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Jobs - Julie Bukar - Founder - JGB BioPharma Consulting Inc

Our job site is updated frequently. New jobs appear on the top of the Complete Job Openings Listing. However, please feel free to send your resume or an email inquiry to Jobs@JGBBioPharma.com. Then we can contact you if a good job fit arises.

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1) Quality Engineer Associate – Contract (Massachusetts) 4005

2) Scientific Director – Contract (New Jersey) 0661

3) Web Content Specialist – Contract (Southern California) 73M5173

4) Material Handler III – Contract (New Jersey) 1722

5) Material Handler III – Contract

6) QC Associate 1 – Contract (Southern California) 5337K73

7) Clinical Supply Technician 1 – Contract (Massachusetts) 7025

8) Buyer Associate – Contract (Massachusetts) 9276

9) Warehouse Operator 1 – Contract (Pennsylvania) 8979

10) Manufacturing Assistant 1 – Contract (New Jersey) 8261

11) Associate Scientist II - R&D – Contract (San Francisco Bay Area) 73J0327

12) Cost Analysis 1 – Contract (Massachusetts) 8205

13) Laboratory Technician II – Contract (Massachusetts) 7650

14) Manufacturing Technician I – Contract (Massachusetts) 6438

15) Financial Analyst III – Contract (New Jersey) 0528

16) Scientist 1 - Analytical Chemist 1 – Contract (Pennsylvania) 7439

17) Work Force Analytics Manager – Contract (New Jersey) 3260

18) Recruiter III – Contract (New Jersey) 6719

19) Senior Biostatistics – Full Time (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) J140FB

20) Compliance Specialist 1 – Contract (Massachusetts) 3138

21) SAS Programmer II – Contract (New Jersey) 6757

22) QA Compliance Specialist – Contract (Massachusetts) 8002

23) Documentation Specialist II – Contract (Massachusetts) 4275

24) Quality Assurance Lead III – Contract (Massachusetts) 3155

25) Documentation Specialist II – Contract (Massachusetts) 8230

26) Laboratory Analyst 1 – Contract (Massachusetts) 3669

27) Project Support Coordinator – Contract (Maryland) 2587J73

28) Manufacturing Associate 1 – Contract (Massachusetts) 6644

29) Manufacturing Specialist III – Contract (Massachusetts) 9544

30) Data Entry Clerk III – Contract (New Jersey) 7644

31) Quality Control Analyst III – Contract (Maryland) 6099

32) Documentation Specialist II – Contract (Massachusetts) 1963

33) Technical Writer III – Contract (New Jersey) 8279

34) Quality Control Analyst II - Chemistry – Contract (Massachusetts) 3550

35) QC Lab LEQ ValidationTechnical Writer I – Contract (Massachusetts) 5429

36) Manufacturing Associate 1 – Contract (Massachusetts) 1773

37) Project Manager II – Contract (New Jersey) 2322

38) Coordinator 1 – Contract (Pennsylvania) 9735

39) Medical Director - Oncology – (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) ZR121P

40) Technologist II: Cell Based Assay Reagent Qualification – Contract (Massachusetts) 0978

41) Clinical Systems Specialist – (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) G113FT

42) Clinical Systems Specialist – (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) G113FT

43) Sr Financial Analyst – Contract (Southern California) 8202A73

44) Admin Assistant II – Contract (Massachusetts) 9195

45) Project Manager 1 – Contract (New Jersey) 9125

46) Facilities Maintenance Admin Coordinator – Contract (Massachusetts) 0170

47) Quality Control Analyst 11 – Contract (Massachusetts) 7557

48) Quality Control Analyst 1 – Contract (Maryland) 7260

49) Clinical Medical Director – Contract (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) GT127M

50) Clinical & Research Assay Team Leader (Manager, Assoc Director, Director) – Full Time (South Korea) TG144F

51) Manufacturing Technician II – Contract (Massachusetts) 0599

52) Manufacturing Assistant 1 – Contract (New Jersey) 7147

53) Vice President, Research and Development – Full Time (New York) T143BR

54) Purchasing – Contract (Maryland) 73V0634

55) Associate Director, Chemical Development – Full Time (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) TH111J

56) Associate Scientist II - R&D – Contract (Maryland) 73P5454

57) Human Resources Administrative Assistant – Contract (Massachusetts) 3120

58) Quality Control Analyst 1 – Contract (New Jersey) 3218

59) Training Specialist – Contract (Massachusetts) 9011

60) Senior Manager, Clinical Site Budget Negotiation – Full Time (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) TC111W

61) Drug Safety Associate – Full Time (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) B111MR

62) Lab Animal Technician II – Contract (Massachusetts) 4994

63) Document Control Clerk – Contract (San Francisco Bay Area) 2092P73

64) Senior Clinical Research Associate – Full Time (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) F82JM

65) Regulatory Affairs Manager – Full Time (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) G125RY

66) Administrative Assistant 1 – Contract (New Jersey) 0037

67) Verification Specialist Reimbursement – Contract (Massachusetts) 1565

68) Quality Inspector II – Contract (New Jersey) 0247

69) Laboratory Analyst 1 – Contract (Pennsylvania) 9302

70) Analyst II - Finance – Contract (Massachusetts) 9507

71) Clinical Project Leader II – Contract (Pennsylvania) 0015

72) Staffing Coordinator – Contract (New Jersey) 0563

73) Associate Director, Clinical Regulatory – Full Time (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) A113KZ

74) Quality Control Analyst 1 – Contract (Massachusetts) 8632

75) Manufacturing Assistant 1 – Contract (New Jersey) 7235

76) CMC Sr. Manager 1 – Contract (New Jersey) 8817

77) Pharmacovigilance Compliance Associate – Contract (Massachusetts) 6205

78) Scientist – Contract (San Francisco Bay Area) 5671J73

79) CMC Project Manager – Contract (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) YP131G

80) Contract Tier Representative – Contract (New Jersey) 7717

81) Executive Director, Development Sciences, Operations Management – Full Time (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) PT113F

82) Admin Assistant IV (Executive) – Contract (New Jersey) 6829

83) Publication Planning Lead (Associate Director Medical Communications) – Full Time (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) A132FJ

84) Copywriter – Contract (Southern California) 73Z0909

85) Clinical Trial Manager for Investigator Sponsored Trials – Contract (New Jersey) 8426

86) Executive Associate – Contract (New Jersey) 6170

87) (Senior) Bioinformatics Scientist – Full Time (New York) GP143V

88) Associate Scientist II - R&D – Contract (San Francisco Bay Area) 73B6551

89) Project Management – Contract (San Francisco Bay Area) 6614K73

90) HTML / Web Content Producer – Contract (Southern California) 73J2298

91) Associate Director/ Director CMC – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) GT113F

92) Project Manager – Contract 9-12 Months (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) P131JF

93) Chemical Engineer Manager – Full Time (Oregon) RZ41M

94) IT Site Manager – Full Time (Oregon) G41JY

95) Project Manager I/II, Pharmacological Sciences Operations – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) Z113FP

96) Clinical Supply Manager – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) GC117R

97) Clinical Supply Manager – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) GC117R

98) Clinical Regulatory, Sr. Associate – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) T113DH

99) Principal Genome Scientist – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) AT103J

100) Financial Systems Analyst – Contract (Southern California) 73B7399

101) Document Control Specialist – Contract (Southern California) 73Z7582

102) High Throughput (HTP) Scientist – Contract (Southern California) 73Y5670

103) Senior Manager, Procurement and Planning – Full Time (Illinois) G73SM

104) Senior Manager, Procurement and Planning – Full Time (Maryland) B73KQ

105) Sr. Manager, QA / QC – Full Time (Maryland) GA73P

106) Senior Director Clinical Development, Respiratory – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) H111BV

107) Senior Java Server Developer - Bioinformatics – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) P103LA

108) Senior Front End Developer for Bioinformatics – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) FB103T

109) Director / Executive Director, Regulatory Affairs – Full Time (Boston Area) GR110B

110) Sr. Director, Clinical Regulatory – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) EH113K

111) EHS Coordinator – Contract (Southern California) 1461D73

112) Manager, Clinical Operations, Oncology – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) HL113W

113) Senior Clinical Research Associate – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) GT113P

114) Scientist II / Senior Scientist Pharmacokinetics/Pharmacodynamics – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) F113KV

115) Associate Director, Project Management – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) BL140Y

116) Director / Sr Director, International Operations – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) G127KM

117) Scientist II, III - Protein Chemistry – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) GR139H

118) CRA III / Sr CRA – Clinical Operations – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) MB139W

119) Clinical Trial Manager – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) A129DK

120) SCRA / CTM (Clinical Operations) – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) DH125N

121) Engineering Technician – Contract (San Francisco Bay Area) 73G4864

122) Health, Safety, and Environment (HSE) Manager – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) B131DM

123) Senior Biostatistician / Manager, Biostatistics – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) B111DK

124) Statistician – Contract (New Jersey) 3817

125) Sr Project Manager Process Improvements & Analytics – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) GP113F

126) Laboratory Technical Supervisor – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) Z138AG

127) Laboratory General Supervisor – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) BX138R

128) Clinical Microbiology Supervisor – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) JP138C

129) Regulatory Affairs Associate / Specialist – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) XR111F

130) Cell Biologist – Contract (Southern California) 73R9202

131) Clinical Project Leader – Full Time (San Francisco/South Bay/Marin/Sonoma/Napa/Santa Rosa/Petaluma) W109FJ

132) Clinical Project Leader – Full Time (San Francisco/South Bay/Marin/Sonoma/Napa/Santa Rosa/Petaluma) W109FJ

133) Clinical Research Associate II – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) VF132D

134) Analytical Chemist – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) Z122EJ

135) Sr QC Stability Associate / Manager – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) BL122T

136) Sr. Project Manager / Associate Director, Oncology – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) P113FX

137) Associate Director / Director Regulatory Affairs – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) RF133J

138) Regulatory Operations Associate – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) A111JP

139) Senior Manager Development Sciences Operations Process Improvements and Analytics – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) RG113T

140) Senior Manager Project and Clinical Process Analytics – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) RG113T

141) Senior Project Manager / Associate Director – Contract to Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) G137AP

142) Interaction Designer – Contract (Southern California) 73R5715

143) Medical Director, Clinical Development – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) GF129B

144) Clinical Assistant – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) M111YV

145) Senior Director / Director, Program Management – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) CY127F

146) Director Clinical Operations – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) A125XL

147) Quality Compliance Team Lead (Asso Dir/ Director) – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) JY131K

148) Senior Manager/Associate Director, Quality Assurance – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) K111DN

149) Senior Manager / Associate Director, Clinical Quality Assurance – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) AL111H

150) Associate Director / Director, Quality Assurance – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) W111EC

151) Senior Scientist (Process Chemical Development) – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) PH111X

152) Scientist / Senior Scientist, Analytical Development (Small Molecules) – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) AL111W

153) Clinical Pharmacologist – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) A133GB

154) CRA I /II – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) S117JT

155) (Senior) Associate Manager CMC Regulatory – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) MA132W

156) Sr Manager , Scientific & Technical Publishing – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) R132GL

157) Senior Medical Director, Drug Safety – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) P111BL

158) Medical Director, Drug Safety – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) TM111Z

159) Director CMC Regulatory – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) XF132H

160) Manager / Sr. Manager CMC Regulatory – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) B132WN

161) Sr Clinical Supply Chain Coordinator – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) R132BN

162) Associate Scientist II - R&D – Contract (San Francisco Bay Area) 1144F73

163) Clinical Program Manager – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) B94RP

164) Senior Java Software Engineer – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) RF103P

165) Supply Chain Manager – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) T82BL

166) Senior Clinical Research Associate – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) F128KZ

167) Specialist, Quality Assurance – 6-12 Month Contract (San Francisco Bay Area) G94LT

168) Manager/Sr. Manager, Clinical Contracts and Outsourcing – Full Time Position (San Francisco Bay Area) RY111J

169) Manager/Senior Manager, Clinical Contracts – Full Time Position (San Francisco Bay Area) C111KP

170) Research Associate – Contract (~ 25 hr/wk for 6 mths or longer; San Francisco Bay Area) B999RT

171) Director / Sr Director Medical Director, Respiratory – Full Time Position (San Francisco Bay Area) Y111AE

172) Senior Medical Director, Drug Safety – Full Time Position (San Francisco Bay Area) MT114A

173) Drug Safety Scientist – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) E114AX

174) Associate Director/Director, Epidemiology – Full Time Position (San Francisco Bay Area) AR114F

175) Systems Engineering Manager – Full Time Position (New York) B126XG

176) Sr. Product Manager – Full Time Position (San Francisco Bay Area) P73AG

177) Associate Medical Director, Respiratory – Full Time Position (San Francisco Bay Area) RT111D

178) Manager, Drug Safety Science – Full Time Position (San Francisco Bay Area) F114JX

179) Manager / Senior Manager, Drug Safety – Full Time Position (San Francisco Bay Area) H114FZ

180) Director, Drug Safety & Pharmacovigilance – Full Time Position (San Francisco Bay Area) GB114A

181) Medical Director – Full Time Position (San Francisco Bay Area) B114TN

182) Sr. QA Associate/QA Manager – Full Time Position (San Francisco Bay Area) G104XB

183) Senior SCRA to Clinical Program Manager Level – Full Time Position (San Francisco Bay Area) W111HL

184) Sr. Manager Training – Full Time Position (San Francisco Bay Area) T114GR

185) Manager, Quality Assurance – Full Time Position (San Francisco Bay Area) D114QF

186) Software Quality Engineer – Full Time (Midwest) RG73B

187) Senior Clinical Research Associate – Full Time Position (San Francisco Bay Area) F114NB

188) Statistical Programmer III – Full Time Position (San Francisco Bay Area) B114NG

189) Principal Statistical Analyst/ Senior Manager, Statistical Programming – Full Time Position (San Francisco Bay Area) G114RF

190) Senior Biostatistician – Full Time Position (San Francisco Bay Area) B114MT

191) Corporate Paralegal – Full Time Position (San Francisco Bay Area) T111KX

192) Clinical Contracts Administrator / Paralegal – Full Time Position (San Francisco Bay Area) GY111P

193) Senior Manager, Clinical GCP Document Control – Full Time Position (San Francisco Bay Area) MT114R

194) Senior Manager, Clinical GCP Document Control – Full Time Position (San Francisco Bay Area) MT114R

195) Director, Statistical Programming – Full Time Position (San Francisco Bay Area) X111JP

196) IVD Systems & Verification Engineer – Full Time Position (San Francisco Bay Area) B118HZ

197) Senior QA Specialist, Manager – Contract to Full Time (San Francisco Bay Area) BK106P

198) Sr. Database Developer (Software Engineering III) – Two Full Time Positions (Midwest) G73RP

199) SCRA / Clinical Trial Manager – Contract or Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) JX111Q

200) Senior Director, Healthcare Compliance – Full Time Position (San Francisco Bay Area) BR114F

201) Clinical Trial Manager / Sr Clinical Trial Manager – Full Time Position (San Francisco Bay Area) RF117Q

202) Scientist (QC) – Contract (Southern California) 2815V73

203) Clinical Project Manager – Full Time Position - 1-2 days/wk in-house (San Francisco Bay Area) ZG104M

204) Scientist II (Purification) – Contract (Southern California) 73T2809

205) Senior Statistical Programmer – Full Time Position (San Francisco Bay Area) ZA111H

206) Recruiting Assistant – Part Time Position (San Francisco Bay Area Preferred)

207) Lead CRA (in-house) – Full Time Position (San Francisco Bay Area) ZW104M

208) Senior Manager, Bioinformatics – Full Time Position (Midwest) B73FN

209) Sr. Staff Scientist, Translational Medicine – Full Time (Midwest) M73QL

210) Staff Scientist, Bioinformatics – Full Time (Midwest) W73BH

211) Scientist III, Bioinformatics – Full Time Position (Midwest) P73NA

212) Senior Data Manager – Full Time Position (San Francisco Bay Area) GL85B

213) Technical Writer – Contract (San Francisco Bay Area) 73N4199

214) Sr. Product Manager, Software Solutions – Full Time Position (San Francisco Bay Area) B73XS

215) Sr. Product Manager, Software – Full Time Position (San Francisco Bay Area) B73XS

216) Clinical Recruiter – Contract or Full Time Position (San Francisco Bay Area) NG104B

217) Diagnostics Product Line Business Owner – Full Time Position (San Francisco Bay Area) RC103X

218) Document Coordinator – Contract (New York) 2223G73

219) Regional Clinical Research Associate – Full Time Position (Texas) N104BX

220) SAS Programmer – Contract (New Jersey) 4345

221) Clinical Database Programmer – Full Time Position (New York / New Jersey) M100PT

222) Human Resources Assistant – Full Time (San Francisco Bay area)

223) Internal Auditor III (Finance) – Full Time Position (San Francisco Bay Area) H95TJ

224) CRAII / Senior Clinical Research Associate II (SCRA) – Full Time Position (San Francisco Bay Area) B111CR

225) Recruiting Coordinator – Contract to Full Time (San Francisco Bay Area)

226) Associate Director – Full time Position (San Francisco Bay Area) Y132Q

227) Equipment Maintenance Technician – Contract (Massachusetts) 6800B73



1) Quality Engineer Associate – Contract (Massachusetts) 4005

DESCRIPTION:

  • Completing document searches, obtaining data and organizing data both hard copy and electronically.  
  • Assist with the editing of quality documents  to ensure compliance with regulatory requirements. 
  • Must be able to work quickly with a high degree of accuracy. 
  • Must possess sound interpersonal and information gathering skills, being able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others.
  • Experience: 0 to 3 years

EXPERIENCE AND QUALIFICATIONS:

  • Able to use Excel and Microsoft Word without assistance.
  • Must have solid computer skills and be able to follow procedures and work in databases.
  • Ability to take direction and complete tasks accurately and completely
  • Bachelors degree required
  • Experience in industry would be helpful

To apply for a position send your resume to Jobs@JGBBioPharma.com

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2) Scientific Director – Contract (New Jersey) 0661

DESCRIPTION:

  • Apply principles and in depth understanding of educational design and outcomes assessment to guide strategic planning, grant review, and identification of the most qualified providers; and 2) cultivate internal and external customer relationships to gain perspectives that influence the ongoing development of educational plans in diabetes area and that demonstrate the value.
  • Must work closely with medical directors as well as cross-functionally within a matrix organization to be effective and to ensure that all IME strategies and tactics, are impactful and are effectively communicated and understood across the company including globally as appropriate, and all activities are compliant with internal and external guidelines, policies and procedures, and 3) externally available to HCPs. 
  • A strong background in successful team management with a strong foundation in diabetes therapeutic area, CME, and principles of adult learning, and education outcomes assessment is required.
  • Develop a strategic medical communication plan and support the execution of the operational and tactical activities within the overall communication platforms for assigned products, technologies, or services. 
  • Must maintain working knowledge of all applicable publication guidelines and regulations, manage projects and recruit/supervise external agency partners, as appropriate to ensure timely delivery of tactics, collaborate with authors of peer-reviewed scientific publications to drive execution of planned publications, ensuring appropriate compliance with internal policies and processes, and understand corporate procurement processes and maintain responsibility for budgets and  spend.
  • Manage the therapeutic medical review and approval of materials (including concepts) in compliance with corporate standards and government/industry regulations.
  • Sustain up-to-date working knowledge of all applicable prevailing guidance, regulation, and law that mandates the nature in which pharmaceutical organizations functions.
  • Define and effectively communicate the medical education and medical communication strategies   
  • Responsible for leading grant review committees to ensure high quality, grant review and decision making (other therapeutic areas may also be assigned) based on defined criteria.
  • Track and manage execution of the diabetes area strategy and budgets from grant decisions through execution 
  • of contract payment and reconciliation.

EXPERIENCE AND QUALIFICATIONS:

  • Doctorate degree from an accredited college or university (e.g., M.D., J.D., PhD, PharmD, or equivalent) 

To apply for a position send your resume to Jobs@JGBBioPharma.com

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3) Web Content Specialist – Contract (Southern California) 73M5173

DESCRIPTION:

  • Methodically reviewing and optimizing indexed catalog data for the best possible customer experience
  • Ensuring that indexed data is clean and of the highest accuracy and quality
  • Running and/or modifying Excel VBA programs to produce data extracts for 3rd parties
  • Administering internal configuration files and search settings (synonyms, dictionaries, type-ahead, etc.)
  • AdHoc analysis of search trend

EXPERIENCE AND QUALIFICATIONS:

  • Very high proficiency in Excel is a must have, data will be manipulated through Excel
  • Excellent communication and the ability to follow up on multiple activities until completion
  • Ability to understand and execute technical tasks with limited supervision and maximum accountability
  • A scientific background in the Life Sciences field with a broad product familiarity
  • A history of working in a web production-focused environment
  • A familiarity with computer programming (VBA)
  • An understanding of basic Site Search functionality (SEO and SEM experience a plus)    
  • Requires a bachelor's degree in a Web technology, Life Science, or Computer science field, or equivalent work experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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4) Material Handler III – Contract (New Jersey) 1722

DESCRIPTION:

  • Responsible for raw material and non-stock receipts; finished goods distribution and the coordination of material movement between warehouse and production areas.
  • Oversight and responsible for daily floor production
  • Performs all aspects of material handling duties
  • Responsible for directing cycle counts activities for assigned facility
  • Ensures timely delivery of all priority receipts
  • Establishes and maintains relationships with customer service groups
  • Manages all sub-inventories and cycle count and processes expired material
  • Recommends new processes or procedures for material handling area
  • Initiates accident and incident reports
  • Provides performance input to management for review

EXPERIENCE AND QUALIFICATIONS:

  • Leadership skills
  • Ability to Interact within other departments
  • Experience with warehouse operations
  • Experience with material handler equipment, including order pickers, reach trucks, and fork trucks
  • Ability to work rotating shifts, overtime and weekends
  • Knowledge of general warehouse and inventory control
  • Ability to make decisions
  • Experience: 6 to 9 years.
  • GED or High School and at least 5 or more years of related experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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5) Material Handler III – Contract

DESCRIPTION:

EXPERIENCE AND QUALIFICATIONS:

To apply for a position send your resume to Jobs@JGBBioPharma.com

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6) QC Associate 1 – Contract (Southern California) 5337K73

DESCRIPTION:

  • Carry out Standard Operating Procedures involved in high throughput manufacturing, visual inspection, material handling and inventory control
  • Quality Control Testing for the production of protein analysis tools
  • Complete all batch records and manufacturing documents according to quality systems standards as required
  • Maintain accurate inventory of products and inventory records using an online materials resource planning tool
  • Complete production schedule to plan maintaining sufficient throughput levels measured on an hourly basis
  • Verbal or written communication of problems to manufacturing leadership and assistance in identifying variables and offering resolutions
  • Escalate equipment issues to technical support through verbal and written communication
  • Keep manufacturing leadership informed of the status of assigned QC processes
  • May train other team members on techniques and processes
  • May perform other related duties as required and /or assigned
  • Interact daily with equivalent levels of personnel in the manufacturing area
  • Attend trainings or read content to understand and follow applicable manufacturing processes and Standard Operating Procedures
  • The job encounters semi-routine work situations of limited scope and complexity where ability to recognize deviation from accepted practice is required

EXPERIENCE AND QUALIFICATIONS:

  • Accuracy is required in performing all functions of this position; errors in work could cause delays in production schedules
  • BS in a Science related field (Biology or Chemistry Preferred)
  • Manufacturing experience
  • Protein Analysis experience
  • Experience with Good Documentation Practices

To apply for a position send your resume to Jobs@JGBBioPharma.com

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7) Clinical Supply Technician 1 – Contract (Massachusetts) 7025

DESCRIPTION:

  • Must be able to ensure work of others is in compliance to established procedures and policies. 
  • The candidate must accurately document information relative to preparation, packaging, and shipping of clinical supplies in accordance with cGMP's and departmental SOP's.
  • The candidate is required to identify deviations and problems to their supervisor.
  • Accurate completion of appropriate documentation relative to the preparation, packaging, and shipping of clinical supplies in accordance with cGMPs and departmental SOPs. This is to include the verification of the work and documentation of other staff members.
  • Perform domestic and International distribution operations; picking and packing of materials according to specific pack-outs to maintain the drug temperatures during transit
  • Perform and Support Warehouse Operations; maintain warehouse locations, in good housekeeping condition, pick or issue materials
  • Participate in cycle counting of inventory, as needed compliance with established procedures, policies, and regulations. Identify any operational deviations and notify the appropriate supervisor.  
  • Assist in conducting investigations, assessment of options and implementation of solutions in order to maintain a fully compliant operation within Clinical Supplies.
  • Participate in secondary packaging and assembly of investigational product (IP) and warehousing activity for domestic and international clinical trials. Position may include clinical label design and generation.  (as needed)
  • Ensure all IP produced is compliant by following the packaging instructions, employing in-process controls and accurate completion of the batch records. 
  • Participate in the set-up of packaging equipment. (as needed)
  • Process Clinical Supply returns; verify returns, enter into database, store until destruction is approved, prepare for destruction (as needed)
  • Complete other tasks and duties as requested

EXPERIENCE AND QUALIFICATIONS:

  • One year working in distribution environment. 
  • Direct experience in Shipping/Picking/Packing and shipment tracking. 
  • Ability to multi task during peak times.           
  • High School Diploma necessary, Associate Degree preferred  

To apply for a position send your resume to Jobs@JGBBioPharma.com

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8) Buyer Associate – Contract (Massachusetts) 9276

DESCRIPTION:

  • Main focus will be on gathering information from suppliers to support the qualification and purchasing of these materials via a controlled system.This includes setting up item master data in the MRP system, organizing and communicating requirements to suppliers, and assessing supplier responses to ensure they meet the requirements.
  • Plans and procures raw materials or other materials including machinery, equipment, tools, packaging materials, parts, services and supplies in support of assigned production areas. 
  • Confers with suppliers and analyzes supplier operations to determine factors that affect prices and determines lowest cost consistent with quality, reliability, and ability to meet required schedules. 
  • Reviews proposals, negotiates prices, selects or recommends suppliers, analyzes trends, follows up orders placed, verifies delivery, approves payment and maintains necessary records. 
  • Procures supplies, raw materials, services, equipment and commodity products for delivery at specified time and location. 
  • Requests quotes from suppliers, performs new supplier sourcing and evaluation.. 
  • Participates in QA Supplier Audits as assigned.
  • Negotiates contracts (to specified value) subject to management approval. 
  • Plans, schedules, and monitors the movement of materials through the production cycle. 
  • Implements value added programs with suppliers in support of production needs. 
  • Adheres to appropriate Standard Operating Procedures for business planning unit to ensure compliance with SOPs, ISO 9000, and cGMP procedures, MRB, and corrective action goals. 
  • Works under very general supervision. 
  • Work is reviewed for soundness of judgment and overall adequacy and accuracy. 
  • Contributes to the completion of organizational projects and goals. 

EXPERIENCE AND QUALIFICATIONS:

  • Proficient in Excel
  • Proficient in Word
  • MRP experience               
  • Bachelor.s degree and/or 3 - 5 years 
  • Relevant work experience. CPM/APICS certification preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

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9) Warehouse Operator 1 – Contract (Pennsylvania) 8979

DESCRIPTION:

  • Responsible for activities supporting the primary and secondary packaging, labeling, and assembly, warehousing, and shipping preparation of investigational drugs used in various clinical studies. 
  • Sign and date batch records for activities performed on all supplies prepared for clinical investigation and verify the work of other production staff members. 
  • Work is assigned and reviewed by Packaging Supervisor, Production Supervisors, Warehouse Supervisor, and/or Team Leaders. Instructions will be in the form of written batch records as well as verbal instructions.


EXPERIENCE AND QUALIFICATIONS:

  • Must be detailed oriented, dependable
  • Able to work independently and also in a team environment. 
  • Must have the ability to read, especially small and repetitive text patterns and the ability to follow numeric sequences and perform accurate counting. 
  • Must be capable of performing repetitive motions and lifting small to medium sized loads of 30 to 50 pounds
  • High School Diploma

To apply for a position send your resume to Jobs@JGBBioPharma.com

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10) Manufacturing Assistant 1 – Contract (New Jersey) 8261

DESCRIPTION:

  • Follows standardized procedures under close supervision in performing assigned unit operations necessary to support production.
  • Performs routine tasks in the areas of Vial inspection, Packaging, Vial Washing, Vial Depyrogenation and Vial Capping.  This includes but it is not limited to loading vials onto the Vial Washer while monitoring critical parameters as per procedures on the vial washer and tunnel, unloading vials from the vial capper and inspecting for defects on the vials, loading the vials onto autoclave racks and adding components to the vial capper while monitoring machine's critical parameters as per procedures.  
  • This job will also entail transfer of heavy vessels on wheels  and autoclave racks on wheels. 
  • Loading vials onto the automated vial inspection machine, changing label reels, loading and taking inventory of packaging items (inserts, labels, cartons, trays, shippers) and loading/taping shippers.
  • Perform routine daily and weekly cleaning of manufacturing area 
  • May serve as witness of routine unit operation tasks for batch record signing. 
  • Maintains all associated documentation for operations being performed.
  • Receives detailed instructions on all work. 
  • All activities are closely supervised and work is reviewed upon completion. 
  • Ability to offload product off carts and onto pallets; move transfer carts in and out of manufacturing area
  • Based on production schedules, random and different start time scenarios may occur so a very flexible work schedule is required for the candidate. 

EXPERIENCE AND QUALIFICATIONS:

  • Prior vial packaging and filling experience desired.
  • Prior mechanical experience and/or experience working as a Production Line Mechanic is preferred.         
  • Typical minimum education and experience required is High School and 1 year of vial packaging and filling experience.  
  • Experience working in a GMP/Pharmaceutical environment is preferred.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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11) Associate Scientist II - R&D – Contract (San Francisco Bay Area) 73J0327

DESCRIPTION:

  • Conduct routine/designed scientific or engineering experiments (may be pre-designed) using laboratory equipment and calculations. Plan use of equipment, materials and own time.
  • Assist or on occasion drive the evaluation and procurement of equipment and materials. Understand the New Product Introduction process and impacts business opportunities through successful task completion. Make detailed observations and analyze data. Maintain accurate lab notebook and training file in accordance with Division standard. 
  • Advise supervisor of factors that may affect quality, accuracy, timeliness and usefulness of data. Assist supervisor in the interpretation of experiment results. 
  • Advises supervisor of factors that may affect experiment; suggests additional experiments. 
  • Suggest options for additional experiments. Plan well understood technical options to reach a specific technical objective. 
  • Troubleshoots experiments. Identify and solve elementary problems in experimental designs. 
  • Contribute ideas and suggestions to improve standard laboratory techniques, improve protocols, processes and equipment. 
  • Lead the documentation of repeatable lab procedures as required. 
  • Read literature directly associated with assigned project. 
  • Maintain some familiarity with competitive products and assist with competitive audits or documentation as required. 
  • Comply with all company safety regulations and procedures. Report non-compliance and may serve as team lead. 
  • Suggest improvements in safety and productivity based on solid technical understanding of expected R&D outcomes. 
  • May be required to perform other related duties as required and/or assigned. 
  • Position exercises judgment within defined procedures and practices to determine appropriate action. 
  • Performs duties independently with only general direction given on routine work. 
  • Receives detailed instruction on new assignments or in the design of experiments. Ability to appreciate importance of project toward Company.s objectives. Job encounters recurring work situations with occasional variations from the norm, involving a moderate degree of complexity. 
  • Works on problems where analysis of situation or data requires a review of multiple identifiable factors. 
  • Accuracy is required in performing all functions of this position. 

EXPERIENCE AND QUALIFICATIONS:

  • Ability to apply basic scientific principles.
  • Excellent communication and problem solving skills are required.
  • Proficient in MS Word, Excel and PowerPoint
  • Experience with oligo synthesis and purification is preferred.
  • Experience in HPLC purification processes for oligonucleotides is desired but not required.     
  • Requires a Bachelor's or a Master's degree in chemistry, biochemistry, Biology or related fields with 0-2 years of experience in R&D or industrial laboratories or the equivalent knowledge and experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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12) Cost Analysis 1 – Contract (Massachusetts) 8205

DESCRIPTION:

  • Assists general accounting, cost accounting, and budgeting for respective management center. 
  • The candidate is expected to contribute toward the completion of the project tasks and assignments. 
  • Works independently under general supervision and direction and is subject to review solely for soundness of judgment and overall adequacy. 
  • Performs work to be used for decision making, assist with gap analysis to ensure business process readiness to implement 
  • Work with the team to identify items that are duplicates, obsolete or inactivate, create plan to items in manufacturing
  • Focus on finance master data for items for both, cogs and non-cogs (i.e. Unit of measure,valuation class, material type, etc).  
  • Compile list of potential corrections that may be needed along with the implications of the proposed corrections. 

EXPERIENCE AND QUALIFICATIONS:

  • Experience in cost accounting within a manufacturing site preferred Knowledge of MFG PRO or similar shop floor manufacturing reporting system 
  • Familiarity with Standard Costing, BoMs, Routings, and work order management.
  • SAP, TM1, Access, advanced Excel, Hyperion, Visio, MFG/Pro (a plus)            
  • Bachelor's degree accounting or finance and 3 - 5 years' experience

To apply for a position send your resume to Jobs@JGBBioPharma.com

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13) Laboratory Technician II – Contract (Massachusetts) 7650

DESCRIPTION:

  • The primary responsibility in this position is routine laboratory testing and analysis of patient samples using established standard operating procedures, tabulating results, and helping with the preparation of patient data reports using a LIMS. 
  • Other responsibilities include assisting with general lab support duties, reagent preparation, light instrument maintenance, and quality assurance and quality control activities in the laboratory. 
  • The candidate will work in a dynamic, fast-paced, CLIA and GLP compliant laboratory which will require the capability of working under minimal supervision, planning and prioritizing assignments to meet timelines while remaining organized.

EXPERIENCE AND QUALIFICATIONS:

  • 3+ year's direct experience using LC/MS/MS methods, software, and instruments in clinical chemistry or regulated bioanalysis applications.       
  • Bachelor's or master's degree in Chemistry, Biology, Biotechnology or Medical Technology

To apply for a position send your resume to Jobs@JGBBioPharma.com

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14) Manufacturing Technician I – Contract (Massachusetts) 6438

DESCRIPTION:

  • Document production activities in batch records, log sheets and attachments.
  • Follow operational procedures and both written and verbal instructions from the supervisor.
  • Perform manual packaging on an assembly line.
  • Identify and communicate process deviations to the supervisor.
  • Keep up to date training on all procedures.
  • Work with hazardous materials
  • Work closely with various level manufacturing and support personnel in a dynamic and team oriented environment.
  • Routinely and safely handle high value product vials in various stages of packaging completion.
  • Use computer based systems for timecards, e-mail and inventory management.


EXPERIENCE AND QUALIFICATIONS:

  • 1-2 years working in a packaging, or equivalent manufacturing environment.
  • High School Diploma / GED.
  • Demonstrated basic math skills.
  • 0-1 year working in a packaging, or equivalent manufacturing environment.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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15) Financial Analyst III – Contract (New Jersey) 0528

DESCRIPTION:

  • Assist the finance group to close the books and present monthly results to business partners on a timely basis. 
  • Assist with providing monthly commentary to explain variances between actual results and / or budget / forecasts. 
  • Consolidate monthly actuals data in central tool from local SAP data
  • Provide support for the monthly performance reports and analysis reporting to marketing and medical teams
  • Marketing and medical teams support 
  • Address any data needs from marketing and medical groups on an ongoing basis. 

EXPERIENCE AND QUALIFICATIONS:

  • Experience: 6 to 9 years.
  • Good analytical and communication skills, strong work ethic     
  • Accounting or Finance degree

To apply for a position send your resume to Jobs@JGBBioPharma.com

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16) Scientist 1 - Analytical Chemist 1 – Contract (Pennsylvania) 7439

DESCRIPTION:

  • Validation, optimization and robustness testing for various assays currently under development
  • Assists in method development, qualification, and troubleshooting, data analysis and management
  • Revision, optimization, and validation of biochemical and immunochemical assays for vaccine in-process testing, release, and stability studies 
  • Also, responsibilities include technology transfer, training, revising/writing SOPs, and providing oral/written summaries
  • Analytical and immunological assay testing for in-process, release and stability samples
  • Inventory, reagent prep, equipment and general laboratory maintenance

EXPERIENCE AND QUALIFICATIONS:

  • Proficient in MS Word, Excel, Powerpoint and Outlook
  • Interact well with a diverse group of individuals
  • Self motivated and willing to be pro active in resolving issues.           
  • BS/MS in Analytical Chemistry, Biotechnology, biochemistry or other Life Science

To apply for a position send your resume to Jobs@JGBBioPharma.com

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17) Work Force Analytics Manager – Contract (New Jersey) 3260

DESCRIPTION:

  • Responsible for developing the HR reporting (reports/dashboards) and analytics that aligns with the company business objectives. 
  • Consults with lead to determine workforce planning needs, analytic needs and proposes options.
  • Responsible for the coordination and analysis of data for the people & organizational development, HR and company talent information.
  • Responsible for managing projects in support of people & organizational group
  • Partner and collaborate with HR, finance and  legal to understand and deliver data needs.
  • In collaboration with HRBP, WFP Lead & HCA, individual will be responsible to provide analytic knowledge and expertise to support business requests across the group. Also this position must ensure collaboration within HR, Finance, and Business to integrate and align data, research and methods as well as the prioritization of analytic work and resources. 
  • Assist workforce planning projects in the development and implementation of workforce planning analytics consisting of, but not limited to, intelligence (environmental scans including complete external labor market scanning and benchmarking of trends, current state analysis), scenario modeling (cost, revenue, and headcount optimization), and gap analysis.
  • Assist in the development of workforce action plans and monitor and reporting needs there of
  • Prepare executive presentations using data and analytics to tell a compelling story
  • Responsible for staying current on analytical trends and assessing viability of analytical options for the organization. 

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor's Degree in Statistics, Finance, or Advanced Mathematics or related field 
  • Five (5) years – Eight (8) years in HR with experience in talent or HR analytics or equivalent data/demographic metrics
  • 5-8 years of practical experience and familiarity with advanced data modeling techniques (linear/logistic regression, ARIMA, Cluster Analysis, etc.) 
  • 5-8 years of experience working with business partners and building relationships 
  • 5-8 years of experience managing multiple priorities and driving multiple projects at once 
  • Advanced level of excel
  • Excellent communication abilities, both written and verbal are essential for leading, coaching and corresponding at all levels of the organization
  • HRIS experience: SAP and Workday (preferred)
  • Ability to formulate statistical calculations and analytic methods 
  • Strong analytical and organizational skills with the ability to manage multiple projects
  • Project management, complex problem solving, process design abilities

To apply for a position send your resume to Jobs@JGBBioPharma.com

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18) Recruiter III – Contract (New Jersey) 6719

DESCRIPTION:

Responsible for partnering with hiring managers in the employment process. In this role, you are the internal staffing partner and employment consultant throughout the entire process. Focus on sourcing, recruiting, assessing and interviewing internal and external candidates for employment within the R&D and Medical Affairs groups. 
Will work with hiring managers to develop specific approaches and strategies to maximize the efficiency and effectiveness of hiring, in addition to continuously developing a pipeline of specific competencies to meet evolving hiring needs and requirements.
  • Conducts interviews to recruit prospective employees and refers job applicants to specific job openings. Evaluates employment factors such as job experience, education and training, skills, knowledge, and abilities, physical and personal qualifications, and other data pertinent to classification, selection, and referral. 
  • Prepares rating on applicants, makes recommendation on starting salaries, and provides applicants with information about the company. 
  • May administer tests and interpret results, check references, extend formal job offers, etc. 
  • May be involved in sourcing and screening candidates for executive-level positions. 
  • Utilizes company knowledge and technical expertise to anticipate issues in the employment area. 
  • Researches and identifies alternative solutions. 
  • Makes recommendations and implements approved changes. 
  • Negotiates with agencies and executive search firms or outside advertising organizations. 
  • May be involved in directing the work of less experienced personnel. Works independently. 
  • Exercises considerable latitude in determining objectives and approaches to assignment. Effects of decisions are long- lasting and heavily influence the future course of the organization. 
  • Serves as consultant to management and special external spokesperson for the organization on matters pertaining to its plans and objectives
  • Responsibility involves driving the end-to-end recruiting process for positions. 
  • Cultivating and sustaining strong relationships with the business to understand hiring needs 
  • Conducting candidate screening 
  • Facilitating the interview process and assessment, including interview scheduling 
  • Providing recommendations to the hiring manager on selection of finalist candidates 
  • Preparing and extending candidate offers and following-up to ensure appropriate on-boarding procedures 
  • Respond to candidate inquires about the overall  program 
  • Attend campus events as needed, travel up to ~15% of time and the ability to attend some evening recruiting events 
  • Provide additional administrative support as needed throughout the businesses and overall Strategic Staffing organization. 
  • Assist with special projects as needed. 
  • Experience: 6 to 9 years.

EXPERIENCE AND QUALIFICATIONS:

          
  • Bachelor's Degree

To apply for a position send your resume to Jobs@JGBBioPharma.com

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19) Senior Biostatistics – Full Time (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) J140FB

DESCRIPTION:

Description:

This position reports to the Director of Biostatistics and has no direct reports. The preferred candidate will have experience in the pharmaceutical or biotechnology environment setting a high bar of excellence in the analysis and reporting of clinical study data to internal stakeholders as well as to external audiences (external experts, journals, regulators). Ideally, this experience would include exposure to the design, analysis and reporting of clinical studies in late stage clinical development.

  • Support the development of innovative and efficient plans for developing new medicines in a variety of therapeutic areas.
  • Works with Biometrics, Clinical Development and Operations, Regulatory Affairs, DMPK and Project Management to meet project deliverables in a timely and scientifically sound manner.
  • Provides technical statistical expertise, innovation and partnership on study design and endpoint selection, calculates sample sizes and prepares the statistical section of study protocols.
  • Independently develops and authors statistical analysis plans.
  • Collaborates in the review of protocols, case report forms, data specifications, CSRs and other study related documents
  • Performs quality control of analysis data and TFLs
  • Utilizes knowledge of guidance documents to provide statistical advice, and uses knowledge of literature to provide data analysis and presentation methods to support publications and presentations.
  • Ability to work on multiple clinical trials across multiple therapeutic areas.
  • Proactively solicits input from others to gain common understanding and agreement.
  • Plans and performs exploratory analyses of existing study data for publications, reimbursement negotiations, drug defense strategies and further development planning.
  • Provides Biostatistical input into strategic decision making
  • Represents the outputs of analyses with key audiences, including internal stakeholders, external experts, DSMBs, regulators and reimbursement committees
  • Plays an active role in shaping late stage development programs (Phase 2B, Phase 3A, Phase 3B)

EXPERIENCE AND QUALIFICATIONS:

  • PhD degree (required) in Biostatistics or equivalent.
  • 2+ years of experience in Clinical Development in a pharmaceutical or biotechnology setting in the statistical analysis of biomedical data.
  • Late-stage development experience in working in teams and in interacting with key internal and external stakeholder groups, including regulatory agencies
  • Working knowledge of the regulations and procedures relating to Biostatistical analysis and interpretation of late-phase development studies
  • Excellent English verbal and written communication skills.
  • Scientific programming capability with statistical software packages; SAS and/or R preferred
  • Detail oriented and well organized.
  • Ability to work on several projects simultaneously.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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20) Compliance Specialist 1 – Contract (Massachusetts) 3138

DESCRIPTION:

  • Provides support for the supplier quality program through the generation and maintenance of supplier quality documentation including supplier files, supplier change notifications, supplier desktop audits.  
  • Maintain the supplier lists.   
  • Work independently with internal clients, suppliers, and cross functional groups. 
  • Frequent internal company and external contacts.  
  • Assist with the revisions of site documents to align with  Global Quality Directives, Standards, and Guidance Documents. 
  • Project Management of assigned initiatives. 
  • Maintains compliance with regulatory as well as company and department policies and procedures. 
  • Contributes to the completion of organizational projects and goals.

EXPERIENCE AND QUALIFICATIONS:

  • Must have a minimum of 1-3 years in a regulated industry
  • Must have previous biologics, biotechnology, pharmaceutical or biopharmaceutical experience
  • Preferred, relevent experience within Quality or Compliance
  • Preferred experience with Supplier Quality
  • Coordinate multiple priorities in a fast paced environment
  • Experience in maintaining CGMP compliance
  • Solid organizational, analytical and problem solving skills
  • Strong communication skills with the ability to interact with all levels throughout the organization
  • In addition, demonstrated excellent interpersonal skills and flexibility
  • Must have understanding and/or working knowledge of CGMP regulations
  • Strong project management skills        
  • Minimum of a BS in Biology, Chemistry, Microbiology or related field 

To apply for a position send your resume to Jobs@JGBBioPharma.com

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21) SAS Programmer II – Contract (New Jersey) 6757

DESCRIPTION:

  • Provide statistical programming expertise in SAS for the production of analyses, tabulations, graphics, and listings from clinical trial data. 
  • Contribute to the preparation of analysis plans. 
  • Prepare, document and test required programs and procedure data displays in an efficient manner for inclusion in integrated clinical, statistical reports and other similar reports. 
  • Contribute to the integrated clinical/statistical report and other similar documents. 
  • Ensure analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming and reporting. 
  • Perform quality assurance procedures on work performed by others. 
  • Develop, test, validate, document, maintain and execute software and/or systems using the currently endorsed tools or support of production activities. 
  • Assist in the integration of data from remote entry sites, contract organizations and co-licensing partners to the central database. 
  • Therapeutic area is internal medicine

EXPERIENCE AND QUALIFICATIONS:

  • Understands the basic skills and goals of reporting clinical data. 
  • Writing knowledge of SAS; SQL and UNIX. 
  • Proven ability to organize workload and priorities and complete tasks on time. 
  • Demonstrated ability to work effectively in a team environment. 
  • Strong interpersonal skills and ability to communicate effectively. 
  • Ability to identify and solve technical problems. 
  • Experience in CDISC Version 2,3 preferred. 
  • Strong experience in SAS analytical database design a must        
  • Must have a science degree and 2+ years working in a pharmaceutical / research environment. 
  • Advanced degree in Science or Mathematics

To apply for a position send your resume to Jobs@JGBBioPharma.com

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22) QA Compliance Specialist – Contract (Massachusetts) 8002

DESCRIPTION:

  • Manage the cleaning verification program for manufacturing areas
  • Issue cleaning paperwork and manage separate logs
  • Review all QC data and document approval or rejection
  • Plan / schedule and execute all provisional release of equipment
  • Communicate delays and off shift support requirements to QA teams
  • Maintain spreadsheets for metrics and schedule
  • Generate weekly on time metrics
  • Attend daily scheduling meeting to understand and changes and communicate QA needs
  • Gowning and lab entry required. 
  • Label GMP process equipment for use based on CV release results. 
  • Reject equipment as needed
  • Attend triage as needed to discuss deviations during CV process

EXPERIENCE AND QUALIFICATIONS:

  • Attention to details
  • Science background
  • Excellent organizational Skills
  • HS diploma and 3-6 years experience

To apply for a position send your resume to Jobs@JGBBioPharma.com

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23) Documentation Specialist II – Contract (Massachusetts) 4275

DESCRIPTION:

  • Work as a team member on cross functional improvement or project teams
  • Maintain the controlled supply of cGMP documents originating within the company
  • Review documents to determine distribution requirements and processes distribution requests according to set procedures
  • Work with primary originators of document to translate the document into written form
  • Ensure the writing, editing, reviewing and approving of documents in a timely manner to meet established deadlines
  • Update and maintain document databases
  • Perform data entry for tracking documents and may provide some guidance to other employees and execute basic training on elementary document control systems
  • Coordinate projects with document originators to meet deadlines
  • Represent department at required meetings as needed

EXPERIENCE AND QUALIFICATIONS:

  • Proficient in Microsoft WOrd, editing and formatting
  • Minimum 2 years' experience in cGMP documentation       
  • High School Diploma / GED

To apply for a position send your resume to Jobs@JGBBioPharma.com

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24) Quality Assurance Lead III – Contract (Massachusetts) 3155

DESCRIPTION:

  • Performance of quality and cGMP compliance activities in accordance with the program schedule
  • Coordination with Site Quality resources to support the needs of the program, such as:  Quality Control Lab, Document Control, Engineering Document Control, Change Control, QA Bulk
  • Performance of Consent Decree Numbered Step oversight activities that are executed consistently, accurately and on time
  • Performance of quality oversight of deliverables related to numbered steps in the Consent Decree Work plan (CDW) in a timely manner
  • Identification and reporting of verification issues
  • Effective communications within their quality team
  • Identification and reporting of quality related risks to the program
  • Collaboration with the team, to help achieve the overall program objectives;
  • Alignment to the standards by developing compliant, simple, sustainable, non-redundant systems that includes the appropriate role of quality;
  • Leverage and alignment of interfaces between all systems through communication across teams;
  • Oversight, performance and coordination of the document control process and compliance oversight of project documents records, local change request process; quality oversight of new facility and utility design, architecture and construction, including associated project documentation);
  • Quality oversight of cycle development (cleaning and sterilization) protocols and reports;
  • Review and approval of technical reports; GMP drawing sets; decommissioning protocols or plans, engineering studies; design specifications; project change forms; procedures, controlled documents and control records; change controls; return to service notifications, corrective maintenance work orders, and action notices; non-conformances, deviations, CAPAs; as they pertain to the program;
  • Review and approval of validation plans, protocols, and summary reports; commissioning and qualification plans, protocols, and summary reports; requalification protocols and summary reports; commissioning test packs including automation test packs, protocols and summary reports; as they pertain to the program;
  • Review and approval of equipment and facility user requirement specifications; system impact and critical aspect analysis; design qualification protocols and summary reports, performance qualification protocols and reports; CCR validation assessment concurrence; computer system validation plans and testing protocols, summaries, reports, trace matrices.
  • Participation in program reviews and risk assessments

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor of Science in Science or Technical field and 7 years of CGMP experience
  • 3 years of experience in Quality Assurance, Engineering or Validation related to Quality support for ongoing manufacturing operations

To apply for a position send your resume to Jobs@JGBBioPharma.com

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25) Documentation Specialist II – Contract (Massachusetts) 8230

DESCRIPTION:

  • Tracking and reviewing change control documentation. 
  • Assist with the editing of quality documents (SOP's, guidelines, validation master plans, etc.) to ensure compliance with regulator requirements. 
  • Must be able to work quickly with a high degree of accuracy. 
  • Must possess sound interpersonal and information gathering skills, being able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others. 
  • Work as team member on cross functional improvement of project teams
  • Maintain the controlled supply of cGMP documents originating within the company
  • Review documents to determine distribution requirements and processes distribution requests according to set procedures
  • Work with primary originators of document to translate the document into written form
  • Ensure the writing, editing, reviewing and approving of documents in a timely manner to meet established deadlines
  • Issue document change requests and document status reports
  • Ensure format of cGMP documents is correct, clear and consistent
  • Update and maintain document databases
  • Perform data entry for tracking documents and may provide some guidance to other employees and execute basic training on elementary document control systems
  • Coordinate projects with document originators to meet deadlines
  • Represent department at required meeting as needed

EXPERIENCE AND QUALIFICATIONS:

  • Experience: 3 to 6 years.
  • Demonstrate strong skills in grammar and punctuation
  • Strong organization skills and attention to detail
  • Must be team and customer oriented
  • Ability to work independently        
  • High school diploma
  • Minimum 2 years experience in cGMP documentation
  • Proficient in Microsoft Word, editing and formatting
  • Associated degree and 2+ years of cGMP documentation experience

To apply for a position send your resume to Jobs@JGBBioPharma.com

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26) Laboratory Analyst 1 – Contract (Massachusetts) 3669

DESCRIPTION:

  • Responsible for performing all technical laboratory processes including clinical testing related activities as required by schedule and as per manager discretion. 
  • Individual will be required to record all data in specified formats and/or maintains a lab notebook detailing day-to-day testing; reporting results of testing activities using electronic, written, oral, or graphical presentation. 
  • Responsible for monitoring, ordering and/or receiving delivery of laboratory supplies and equipment, and will be responsible for and/or performing lab and/or facility housekeeping and maintenance. 
  • Must ensure that corporate, quality, regulatory and safety procedures/requirements are being observed and followed at all times

EXPERIENCE AND QUALIFICATIONS:

  • Background in Microbiology, Microbial Identification and Microscope use experience          
  • Associate degree in Microbiology or relative science and 2-3 years experience or Bachelor's degree in Microbiology or relative science and 0-1 year experience

To apply for a position send your resume to Jobs@JGBBioPharma.com

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27) Project Support Coordinator – Contract (Maryland) 2587J73

DESCRIPTION:

  • Maintains skus within Agile PC & E1 software including creation of new skus, corrections to existing skus, data cleanup, report generation and other Agile related duties as assigned.
  • Creates label specifications for new products and corrections to specification of existing products.
  • Work with operation to change or add new BOM, Bill of material or create part numbers for new NPI.
  • Initiate ECO (Engineering change over for newly created part numbers and timely BOM creation into E1 / ERP system.
  • Collaborate with NPI Project Manager to ensure that timelines and deliverables are met for the projects as they transfer.
  • Conduct required Agile and E1 activities related to establishing and releasing a sku for sale to ensure that all deliverables are met in order for the products to be released on schedule
  • May be required to perform other related duties as required and/or assigned.
  • Occasional local travel may be required. 
  • The Successful candidate will be able to demonstrate the ability to work at the required pace and accurately in a fast moving environment.

EXPERIENCE AND QUALIFICATIONS:

  • Ability to work in a reasonably autonomous fashion, within a matrix environment, supporting operations
  • Excellent time management skills and ability to work independently as required.
  • Excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple and changing projects and priorities.
  • Strong collaborative and team-oriented approach
  • Attention to detail
  • Problem-solving skills
  • Strong communication skills (both verbal and written)
  • Ability to multi-task in support of a diverse and complex set of needs
  • Knowledge and understanding of cGMP and ISO guidelines in a laboratory environment
  • Basic computer skills including word processing and spreadsheet applications.
  • Associate's degree or higher
  • At least two years' experience working in a Project related environment

To apply for a position send your resume to Jobs@JGBBioPharma.com

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28) Manufacturing Associate 1 – Contract (Massachusetts) 6644

DESCRIPTION:

  • Operates general manufacturing equipment under close supervision in accordance with current GMPs or standardized procedures and within safety guidelines. 
  • Requires good documentation skills and attention to detail. 
  • Tasks to be completed may include fermentation, protein purification, solvent extractions, tissue culture, preparation of bulk solutions, aseptic fills of buffers, filling and labeling of vials under sterile and non-sterile conditions, routine buffer and media preparation, filtration, vial preparation and sterilization. 
  • Operates general manufacturing equipment in strict accordance with SOPs to complete tasks as noted above as well as large scale bioreactor operations, critical small or large volume sterile fills, and aseptic manipulation of cell cultures. 
  • Operates with minimal supervision complex systems and equipment and optimizes their use in accordance with defined goals. May participate in plant trials for evaluating process modifications. 
  • Troubleshoots processing problems. 
  • Assists in the implementation of production procedures to optimize manufacturing processes. 
  • May attend research meetings related to the transfer process of new products. 
  • May prepare monthly operating reports for use in the analysis of the performance of the unit. 
  • Participates in authoring complex, explicit documentation for manufacturing operations. May provide training to new personnel in a specific technical process. 
  • Demonstrated ability in the application of requisite skills and applies additional skills and knowledge acquired through experience to perform the more complex tasks of the position. 
  • Generally receives no instructions on routine assignments while under little or no supervision. 
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

EXPERIENCE AND QUALIFICATIONS:

  • Experience in Buffer/Dispensary, Cell Culture or Purification
  • 1 year experience with deviation or investigation management systems
  • Training, coaching, leadership experience.
  • Experienced leading and influencing cross-functional teams
  • Experience with Cycle development, Shakedown, Engineering support, Commissioning and Qualification, and Validation of process equipment
  • Experienced authoring and reviewing standard operating procedures, on-the-job-trainings, and other controlled documents
  • Familiarity with deviation management systems (i.e. Trackwise).
  • Experience in troubleshooting, investigation, and root cause analysis in a current good manufacturing practices (CGMP) environment.
  • Bachelor's or Associate's Degree with 5-7 years in CGMP manufacturing environment

To apply for a position send your resume to Jobs@JGBBioPharma.com

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29) Manufacturing Specialist III – Contract (Massachusetts) 9544

DESCRIPTION:

  • The Facilities Specialist uses process knowledge to manage and own all Preventative Maintenance (PM) related process documents, to include: investigations, training, and improvement initiatives within a defined area.
  • Assists with the Document Change Request (DCR) for all process related SOPs and Preventative Maintenance (PM) Records ensuring accuracy and consistency. The Facilities Specialist authors complex, explicit documentation for new and current procedures.
  • Assists in the process of deviation management and root cause analysis for applicable deviations. The Facilities Specialist creates and presents trending and metrics reports on deviations and corrective actions.
  • Develops Facilities training curricula and works with Supervisors and the Quality Training group to develop and ensure consistency in training materials through the on-the-job training program on process operations, theory, and compliance. Occasionally performs training with staff on the floor as well as train-the-trainer activities. 
  • Effectively demonstrates an understanding of CGMPs & how it applies to specific responsibilities.
  • Practices safe work habits and adheres to safety procedures and guidelines.
  • Trains new employees.
  • Routinely interacts with support groups. Understands and maintains production schedule. May recommend development opportunities for less experienced co-workers
  • Collaborates with MFG, QA, QC, MTS, Validation, Scheduling, and Manufacturing Engineering to
  • implement change in process, procedures, project milestones, and work practices.
  • As a continuous improvement driver, the Facilities Specialist helps manage the implementation of projects and new business processes and systems.

EXPERIENCE AND QUALIFICATIONS:

  • Experience working for a maintenance organization in a CGMP Biotech/Pharmaceutical manufacturing environment
  • Training, coaching, leadership experience.
  • Experience with Cycle development, Shakedown, Engineering support, Commissioning and Qualification, and Validation of process equipment
  • Experienced authoring and reviewing standard operating procedures, on-the-job-trainings, and other controlled documents
  • Experience with TrackWise, LiveLink, Gage Insight (IndySoft) and Microsoft Office
  • Experience in troubleshooting, investigation, and root cause analysis in a current good manufacturing practices (CGMP) environment.   
  • Bachelor's Degree with a minimum 5 years of experience in Manufacturing, Quality or Facilities / Engineering

To apply for a position send your resume to Jobs@JGBBioPharma.com

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30) Data Entry Clerk III – Contract (New Jersey) 7644

DESCRIPTION:

  • Review payroll timekeeping input to ensure timely completion and accuracy
  • Compare timekeeping systems with employee pay to ensure compliance with proper processes.  
  • Partner with retained payroll team and payroll vendor to resolve issues and identify areas of process improvements.

EXPERIENCE AND QUALIFICATIONS:

  • Strong attention to detail; familiarity with hourly timekeeping practices.  
  • Ability to interact with all levels of the organization.  
  • Multitasking capabilities and ability to organize large quantities of information.
  • College degree preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

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31) Quality Control Analyst III – Contract (Maryland) 6099

DESCRIPTION:

  • Performs operations necessary for quality testing and plays a role in implementing new technology within quality control. 
  • Conducts data review and preliminary evaluation of results. 
  • Solves problems using limited predetermined options such as repeating the assay when parameters are not met to determine the cause, etc. 
  • Provides input to the technical composition of operating documentation. 
  • Follows standard practices to obtain solutions. 
  • Contributes to the completion of routine technical tasks. 
  • Collate data, perform data entry into MS Excel, and draft quarterly and annual trend reports.
  • Perform routine environmental monitoring and clean utility sampling to ensure that environmental classifications are met.
  • Assist in cleaning and organizational tasks in order to prepare the QC laboratory and office areas for audits and regulatory inspections.

EXPERIENCE AND QUALIFICATIONS:

  • Experience: 6 to 9 years.            
  • Environmental monitoring using air particulate counters
  • Surface and air sampling for viable microorganisms
  • Water sampling and bioburden testing
  • Compressed gas sampling
  • Culturing microorganisms
  • Microbial identification using a Vitek
  • Data trending
  • MS Excel and MS Word Proficiency Required
  • The individual would preferably have QC experience in a biotech GMP environment.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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32) Documentation Specialist II – Contract (Massachusetts) 1963

DESCRIPTION:

  • Perform record issuance and reconciliation activities.
  • Interact/update/maintain the record management database.
  • Initiate/perform periodic record audits.
  • Point of contact for customer record management discussions.
  • Point of contact for record off-site storage and retrieval.
  • Interact/update offsite records management vendor database.
  • Assist with record destruction.

EXPERIENCE AND QUALIFICATIONS:

  • Demonstrated experience with Word and Excel
  • Effective verbal and written communication skills.
  • Strong attention to detail skills.
  • Effective time management and organizational skills.
  • High school degree or 1-3 years' experience in Quality or Operations experience in a cGMP environment.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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33) Technical Writer III – Contract (New Jersey) 8279

DESCRIPTION:

  • Prepares and edits technical SOP/ SWI, and WIN documents. 
  • Ensures documents meet editorial and customer specifications and adhere to standards for quality, graphics, format, and style.
  • Interfaces with process owners and subject matter experts to coordinate, write and edit drafts. 
  • Ensures and follows workflow of documentation in QDMS and eDOC document management systems. 
  • Participates as member of the project team. 
  • Tracks project documentation through creation, approval, publication, and update of life cycle.

EXPERIENCE AND QUALIFICATIONS:

  • Quality documentation software experience 
  • Experience with documentation and workflow systems such as QDMS, eDOC.
  • Bachelor's Degree or Higher

To apply for a position send your resume to Jobs@JGBBioPharma.com

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34) Quality Control Analyst II - Chemistry – Contract (Massachusetts) 3550

DESCRIPTION:

  • Responsible for testing intermediate and final product samples to demonstrate that all products meet all standards required for CGMP operations. Various techniques are utilized in QC including, HPLC, GC, gel electrophoresis and multiple types of spectrophotometry. Additional functions include raw material testing, stability testing, assay transfers and the qualification of new instrumentation utilized in the QC laboratory.
  • Responsible for performing routine and complex testing of in-process samples and final products in accordance with SOPs for product release and validation. 
  • Performing UV-Vis spectrophotometry assays for in-process and final product samples
  • Performing HPLC methods for final bulk material/finished goods
  • Performing maintenance on complex laboratory equipment including HPLC and GC systems
  • Review of QC Data for compliance to procedures and specifications
  • Calculation and evaluation of results
  • Participation in training of less experienced staff
  • Transferring methods from support groups to the QC laboratory
  • Authors protocols and technical reports related to the implementation of QC equipment
  • Effectively demonstrates an understanding of CGMP's and how it applies to specific responsibilities:
  • Following accurate oral and written procedures for testing of in-process and final product samples
  • Communicates inter-departmentally and with outside contacts to solve technical issues
  • Exercises sound judgment and decision making when problem solving
  • Revises standard operating procedures as needed
  • Works independently under general supervision and direction
  • Work in compliance with CGMP's

EXPERIENCE AND QUALIFICATIONS:

  • Proficient in Outlook and Microsoft Word and Excel and lab based data management systems
  • Experience with UV Vis Spectroscopy and wet chemistry
  • Scientific technical writing ability
  • Bachelor's Degree in Life Sciences or Master's Degree in Life Sciences discipline and 1 year experience in CGMP lab environment

To apply for a position send your resume to Jobs@JGBBioPharma.com

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35) QC Lab LEQ ValidationTechnical Writer I – Contract (Massachusetts) 5429

DESCRIPTION:

  • Draft protocols and reports for Laboratory Equipment Qualification (IQ, OQ, and PQ) according to company policies.
  • Assist multiple teams of technical experts in the technical writing of Laboratory Equipment Qualification
  • Requires working with QC staff that will provide document redlines and review completed work.
  • Revisions of EQ documentation must be done utilizing defined content and formatting requirements.
  • Prior experience with Livelink a plus.
  • This person should be very familiar with documenting Laboratory Equipment Qualification / validation studies, specifically pertaining to QC. 
  • Familiarity with cGMP is required. 
  • Organize documentation and cross-reference documents as necessary.
  • Edit, standardize, or revise material prepared by other writers or subject matter experts.
  • Prepare rough drafts of the documentation for review with subject matter experts, project staff and/or customers.
  • Technical writer will be trained in company SOP do

EXPERIENCE AND QUALIFICATIONS:

  • Must write in a concise and easy-to-read manner.
  • Excellent writing and editing skills.
  • Able to actively listen to what other people are saying and ask questions as appropriate.
  • Able to work with new material or information to grasp its implications.
  • Able to type 50 - 60 words/min proficient with MS Word, Excel, and PowerPoint
  • Bachelor's Degree required

To apply for a position send your resume to Jobs@JGBBioPharma.com

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36) Manufacturing Associate 1 – Contract (Massachusetts) 1773

DESCRIPTION:

  • Effectively demonstrate understanding of cGMPs and how they apply to specific responsibilities
  • Accurately complete all appropriate production documentation
  • Identify, escalate, and document events that deviate from normal operation
  • Maintain the cleanliness and orderliness of the processing area
  • Stock production area with supplies as necessary
  • May perform support functions for more senior operators
  • Perform cleaning operations to prepare the equipment as well as the area for manufacturing operations
  • Identify and assist with troubleshooting of routine issues and/or defects.
  • Follow verbal and written procedures in operating production equipment and performing process steps

EXPERIENCE AND QUALIFICATIONS:

  • Basic navigation of Microsoft Office
  • Ability to gown and gain entry to manufacturing areas
  • Extended experience operations in with sterilization techniques.
  • Experience in a GMP environment using autoclaves and parts washer.
  • Experience with computer programs.
  • High School diploma/GED with 1-3 years of experience or Bachelor's Degree with no prior experience.
  • Preferred Associate's, Bachelor's or equivalent degree in science related field.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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37) Project Manager II – Contract (New Jersey) 2322

DESCRIPTION:

  • Drive timely resolution to assigned audit findings, ensuring that implication of process changes is considered across all relevant processes and areas of the businesses.  
  • Collaborate with the different parts of the business to bring about standardized resolution that will not increase risk to any guiding policies (internal or external) and will ensure compliance. 
  • Lead cross functional project teams to drive forward process improvement projects, ensuring consistency across all applicable SOPs and policies, including training plan development, process implementation and monitoring
  • Ensure standardization of process execution for all activities applicable to the different groups.
  • Collaborate with compliance, legal and transparency to ensure that any risk related to assigned areas are addressed within processes and continue to monitor to ensure that we remain in compliance with these and any changes made to external policies that regulate our business.
  • Manage tracking system for all audit resolution activities ensuring that activities are completed by the assigned deadline
  • Performs other duties as assigned.

EXPERIENCE AND QUALIFICATIONS:

  • Project management experience
  • Strong communication skills
  • Experience with one or more of the following areas:  compliance auditing, pharmaceutical process improvement,  IME, ISTs, Publications, pharmacovigilance or EBM preferred
  • Working  knowledge and understanding of the external environment that influences Medical Practices and the regulations and guidances such as the OIG, PhRMA Code, FDA
  • Looking for global QA and compliance experience
  • Bachelor's degree from an accredited four-year college or university
  • Minimum of 5 years of experience in the Pharmaceutical industry

To apply for a position send your resume to Jobs@JGBBioPharma.com

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38) Coordinator 1 – Contract (Pennsylvania) 9735

DESCRIPTION:

  • Primary role is to provide high level support to the clinical supplies team with minimal supervision, and to exercise discretion and solve moderately complex problems. 
  • Enter/update shipments/addresses into the Clinical Supplies Management System (CSMS). 
  • Attach regulatory documents in the CSMS and transition the site to the appropriate shipping status. 
  • Review shipment request in the CSMS to ensure all required documents have been attached, verify that the shipping addresses are correct and to select and approve the appropriate kits. 
  • Scan all Clinical Supplies Shipping Request into the appropriate data base
  • If required, e-mail/call the investigative sites to return copies of the acknowledgement of receipt. 
  • Attach tracking confirmation in the CSMS and transition the system to the appropriate status
  • Complete the IP stock management and IP Tracking tools entries. 
  • Enter financial tracking in to the appropriate system (ACTIME). 
  • E-mail Miscellaneous Shipping Forms for processing to appropriate locations(s) 
  • Filing as required 
  • Work with internal and external customers, including other areas such, Legal, Finance, Purchasing, GMA, R&D, vendors, consultants 
  • Coordinate/assist with departmental projects and processes 
  • Assist other members of department on specialized projects as appropriate, and act as a resource person for the department 
  • Establishes courses of action for self and others to ensure that work is completed efficiently. 

EXPERIENCE AND QUALIFICATIONS:

  • Detail oriented, self-motivated, and able to prioritize. 
  • Demonstrates strong organizational skills.
  • Demonstrates strong communication skills (verbal/written) that can clearly convey information and ideas. 
  • Provides consistent and balanced communications. 
  • Must be able to effectively communicate with all levels of associates and customers in a global and multicultural environment. 
  • Ability to Multi-Task and manage heavy workloads
  • Must be able to work autonomously with minimal supervision. 
  • Must be able to handle multiple tasks simultaneously and provide high quality work. 
  • Must be able to work under tight deadlines. 
  • Ability to work well within cross-functional and internal teams. 
  • Works effectively and cooperatively with others; establishes and maintains good working relationships. Shares, encourages, and actively engages with colleagues.
  • Prior pharmaceutical/biotech Industry experience
  • Knowledge of Inventory Management Systems
  • Expertise with Microsoft Applications (word, excel, powerpoint)
  • Prior logistics experience
  • Bachelor’s degree preferred (Associates Degree combined with experience will be acceptable).

To apply for a position send your resume to Jobs@JGBBioPharma.com

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39) Medical Director - Oncology – (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) ZR121P

DESCRIPTION:

  • Report to the Chief Medical Officer and provide medical direction for the oncology clinical programs
  • Lead the clinical strategic efforts for the oncology programs
  • Lead and develop all protocols for the oncology programs and work closely with the clinical investigators and the project teams
  • Provide medical monitoring for sponsored oncology trials
  • Establish and lead efforts for publication planning and investigator sponsored trial program
  • Lead advisory boards and investigator meetings
  • Lead clinical research teams, and play a very active role on project teams
  • Prepare and deliver proposals, plans and updates to the governance committees at regular intervals and when requested
  • Develop processes and standards that are in accordance with GCP and ICH guidelines to enable efficient and consistent clinical activities
  • Work effectively with internal stakeholders (e.g. Biometrics, Research, Regulatory Affairs, CMC) and external stakeholders (e.g. investigators, FDA, NCI) to ensure efficient execution of the clinical programs
  • May be required to manage other clinical personnel as needed

EXPERIENCE AND QUALIFICATIONS:

  • Thorough understanding of clinical hematology/oncology and the drug development process from phase I-III. Significant experience with later stage clinical trials, successful track record of NDA/BLA submissions, and experiences with FDA and ex-US regulatory authorities are highly desired
  • Deep understanding of cancer cell biology and its application to clinical experimentation
  • Thorough understanding of relevant nonclinical development in hem/onc area
  • Strong implementation skills
  • Substantial experience with developing clinical protocols and medical monitoring
  • Must have good rapport with investigators and viewed as a peer to investigators; pre-existing relationships with global KOLs a plus
  • Familiarity with ICH and other regulatory requirements related to clinical activities
  • Strong and demonstrated effective leadership of multi-disciplinary teams including an ability to appropriately prioritize and resource to drive for results, use sound judgment in complex situations, to effectively influence and work with others at multiple levels within and outside the organization is required
  • Ability to work independently within a defined strategic context, contribute to strategy and take initiatives and assess risks
  • Excellent organizational, communication, and presentation skills
  • Willingness to travel as needed
  • MD or equivalent with Board certification in Hematology/Oncology or related discipline (PhD with relevant experience would be considered)
  • A minimum of 8+ years experience in drug development phase I-III in the pharmaceutical or biotech industry

To apply for a position send your resume to Jobs@JGBBioPharma.com

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40) Technologist II: Cell Based Assay Reagent Qualification – Contract (Massachusetts) 0978

DESCRIPTION:

  • Responsible for patient immune surveillance, pharmacokinetic, and biomarker support for clinical trials and post-marketing programs. The group develops assays and monitors treatment efficacy and immune responses to therapeutic products. 
  • Work in a GxP environment as part of a fast-paced team to maintain assays used to support clinical sample testing. 
  • Responsibilities include qualification and optimization of new reagents used in various cell-based assays.
  • Performs all necessary laboratory assignments, including: preparing reagents, quality control, and thorough documentation of all work in a team-oriented work structure. 
  • Maintain and propagate mammalian cells. 
  • Execute and analyze cell-based assays according to detailed protocols. 
  • Review assays for quality control acceptability, maintain QC records and instrument/equipment records. 
  • Perform preventative maintenance and calibrations on equipment. 
  • Takes individual responsibility for and participates in a team approach to work flow management. 
  • Demonstrated ability in the application of the requisite skills to perform the required tasks of the position. All lab related activities of a technical nature require review as mandated by laboratory standard operating procedures. 
  • Assignments are task-oriented with detailed instructions and work is closely supervised. 

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor's degree in Science-related field and 3-5+ years laboratory experience. 2+year experience maintaining cultured cell lines.
  • Proficient in Microsoft Word and Excel. Experience in flow cytometry and analysis of data using FlowJo. 
  • Experience with Prism and JMP software. 
  • Experience working in a regulated environment (ie: GLP-like).

To apply for a position send your resume to Jobs@JGBBioPharma.com

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41) Clinical Systems Specialist – (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) G113FT

DESCRIPTION:

  • Responsible for providing the day-to-day management , maintenance and support of development sciences systems, the development of custom reports, system integration and the flow of data between systems, and involvement in the implementation of new systems.
  • Manages system administration and user support for multiple systems in development sciences.  These may include systems used in clinical operations, regulatory, biometrics, pharmacovigilance, pharmacological sciences, and business intelligence/data visualization tools.
  • Understands and responsible for existing data architecture of systems.
  • Participates in system implementation activities, including participation in business process analysis and requirements gathering.
  • Ability to develop test plans and procedures.
  • Contributes to the development of systems-related process documentation and training materials.
  • Manages and monitors data transfers between relevant systems.
  • Manages user and master data administration.
  • Participates in system validation activities.
  • Works with staff to refine systems needs, implement processes and systems, and foster an environment for continuous improvement.
  • Scopes, develops and maintains custom reports and dashboards using business intelligence and data visualization tools (e.g. OBIEE, Crystal Reports, etc.)
  • Provides technical expertise for the development of new data structures for reports

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor's degree or equivalent experience in biotechnology, science or computer science
  • 5 years demonstrated experience providing application support, maintaining user accouts and performing simple configuations in a pharmaceutical or biotechnology environment
  • Expert knowledge of relational databases and SQL
  • Expert knowledge in reporting tools
  • 2 years experience gathering requirements or performing business analysis activities
  • Demonstrated ability to work independently and manage multiple tasks and projects
  • Strong communication  and customer service skills
  • Knowledge of or experience with data warehousing structures and principles
  • Experience with one or more of the following systems is preferred: document scanning and management systems ( LiveLink, Sharepoint) eTMF systems,  CTMS  (Siebel Clinical, Medidata CTMS, TrialWorks), IxRS (Bracket, Almac, Balance), sample management systems, Regulatory publishing systems, EDC, SAS, Safety systems, LIMS.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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42) Clinical Systems Specialist – (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) G113FT

DESCRIPTION:

  • Responsible for providing the day-to-day management , maintenance and support of development sciences systems, the development of custom reports, system integration and the flow of data between systems, and involvement in the implementation of new systems.
  • Manages system administration and user support for multiple systems in development sciences.  These may include systems used in clinical operations, regulatory, biometrics, pharmacovigilance, pharmacological sciences, and business intelligence/data visualization tools.
  • Understands and responsible for existing data architecture of systems.
  • Participates in system implementation activities, including participation in business process analysis and requirements gathering.
  • Ability to develop test plans and procedures.
  • Contributes to the development of systems-related process documentation and training materials.
  • Manages and monitors data transfers between relevant systems.
  • Manages user and master data administration.
  • Participates in system validation activities.
  • Works with staff to refine systems needs, implement processes and systems, and foster an environment for continuous improvement.
  • Scopes, develops and maintains custom reports and dashboards using business intelligence and data visualization tools (e.g. OBIEE, Crystal Reports, etc.)
  • Provides technical expertise for the development of new data structures for reports

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor's degree or equivalent experience in biotechnology, science or computer science
  • 5 years demonstrated experience providing application support, maintaining user accouts and performing simple configuations in a pharmaceutical or biotechnology environment
  • Expert knowledge of relational databases and SQL
  • Expert knowledge in reporting tools
  • 2 years experience gathering requirements or performing business analysis activities
  • Demonstrated ability to work independently and manage multiple tasks and projects
  • Strong communication  and customer service skills
  • Knowledge of or experience with data warehousing structures and principles
  • Experience with one or more of the following systems is preferred: document scanning and management systems ( LiveLink, Sharepoint) eTMF systems,  CTMS  (Siebel Clinical, Medidata CTMS, TrialWorks), IxRS (Bracket, Almac, Balance), sample management systems, Regulatory publishing systems, EDC, SAS, Safety systems, LIMS.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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43) Sr Financial Analyst – Contract (Southern California) 8202A73

DESCRIPTION:

  • To review, analyze and perform all duties required to effectively monitor project capital and expenses within the IT and ERP teams. Participation and leadership will be required to facilitate various corporate initiatives and projects. 
  • Participates in projects to improve the operational and financial effectiveness of the team. Extracts financial data from various accounting and information systems. 
  • Performs statistical, cost, and financial analysis of data reported in the various financial systems. Utilizes a knowledge of the company's financial systems, such as Hyperion, Cognos and JDE.
  • Assists in the analysis of financial data and extracts and defines relevant information; interprets data for the purpose of determining past financial performance and/or to project a financial probability.
  • Develops financial reports for forecasting, trending, and results analysis, interprets financial results. 
  • Uses various software applications, such as spreadsheets, relational databases, statistical packages, and graphics packages to assemble, manipulate and/or format data and/or reports. 
  • Excellent written and oral communication skills are required. 
  • Must be able to interface effectively with all levels of company employees. Requires a functional knowledge of corporate operations.
  • Job encounters recurring work situations with occasional variations from the norm, involving a moderate degree of complexity. Accuracy is required in performing all functions of this position. 
  • Must demonstrate judgment, tact and diplomacy in dealing with internal and external customers as well the ability to handle confidential and proprietary information. 
  • Initiative and organization skills are extremely valuable to ensure a smooth office operation. 
  • Must possess self-motivation, enthusiasm, and a positive attitude and perform as a team player.

EXPERIENCE AND QUALIFICATIONS:

  • This position interacts with varying levels of personnel requiring the ability to clearly communicate verbally and in writing. 
  • Effectiveness in this role requires a functional knowledge of corporate operations. 
  • The incumbent determines own practices and procedures and contributes to the development of new concepts. 
  • Decisions are made within policy constraints; solutions are expected to be creative and practical. 
  • Performs routine duties independently with minimal instruction given on new projects or assignments. Job encounters recurring work situations with frequent variations from the norm, involving a diverse scope and high degree of complexity. 
  • Accuracy is required in performing all functions of this position; mistakes in work could cause substantial data errors and financial loss.The incumbent must possess self-motivation, enthusiasm, and a positive demeanor toward the job, the company and their work team.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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44) Admin Assistant II – Contract (Massachusetts) 9195

DESCRIPTION:

  • Support managers with administrative duties related to metrics management, presentations, asset management and space planning for the site. 
  • Provide administrative support to one or more Directors/Managers and actively participates at various committees  
  • Specific duties and responsibilities may vary based on department and level(s) of management supported. 
  • Responsibilities may include preparing correspondence, reports, tables, and some analyses. 
  • May direct telephone calls and visitors; sorts and distributes mail. 
  • Coordinates (at times complex) on/off site meeting logistics, coordinate meetings where some of the attendees, maintains calendars, makes travel arrangements, etc. 
  • Provides clerical support as necessary: filing, faxing, copying, data entry, etc. 
  • May respond to routine inquiries for information according to department guidelines. 
  • Completes other duties as requested.

EXPERIENCE AND QUALIFICATIONS:

 
  • Candidate who is competent in Excel, statistics, Visio, PowerPoint, Outlook and other in-house applications. 
  • Outstanding organizational skills, strong computer/pc skills, and an aptitude to quickly learn new technologies as part of the job (i.e. how to schedule video meetings) are essential skills. 
  • Ideal candidate will also have a strong design eye for presentation and good interpersonal skills including communication to work with many types of people.         
  • HS Diploma. 
  • College degree preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

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45) Project Manager 1 – Contract (New Jersey) 9125

DESCRIPTION:

  • Work to ensure alignment across the various medical affairs stakeholders, creating and maintaining project plans that include timelines and approved budgets and ensure adherence to plan and/or strategic risk mitigation development.
  • Support assigned teams in development of project plans including team membership, project scope, deliverables and timelines.
  • Drive project management support of key projects to ensure deliverables are met and on time. 
  • Project management support includes but is not limited to development and maintenance of timelines, critical analysis of risks to project deliverables and forecasted budget, alignment of team members.
  • Support the project management office with the monthly reporting process, tracking projects.
  • Support the standards group with the management and review of the audit resolution and process monitoring tracking process.
  • Ensure communication across various project teams to ensure alignment of changes 
  • Support process improvement and challenge teams to thinks transversally across the organization to ensure streamlining and implementation of best practices

EXPERIENCE AND QUALIFICATIONS:

  • BS degree
  • Minimum of 5 years of experience managing projects
  • Minimum of 5 years pharmaceutical experience in clinical research or medical affairs
  • Strong understanding of Adverse Event reporting requirements
  • Strong organization and communication skills

To apply for a position send your resume to Jobs@JGBBioPharma.com

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46) Facilities Maintenance Admin Coordinator – Contract (Massachusetts) 0170

DESCRIPTION:

  • Schedule personnel for new employee training, and subsequent assignment of site-based training curricula.
  • Responsible for the safe record keeping of all facilities maintenance work orders
  • Assist management with recording/processing all documentation and forms
  • Provide on-going customer support (e.g. reports, assistance with training systems/programs, etc.) for all internal clients.
  • Collaborate with internal clients to analyze, design, develop, implement, and measure effectiveness of procedures based on identified business needs.
  • Work with area supervisors to manage assignments and tasks
  • Manage projects and initiatives which directly support area operations.
  • Maintain SOP manuals up to date; audit annually.
  • Monitor department activities to ensure compliance.

EXPERIENCE AND QUALIFICATIONS:


  • Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as policies and procedures.
  • Acting as role models for fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
  • Bachelor's Degree and 3 years of experience working in a regulated environment.
  • Proficiency in Microsoft PowerPoint, Word and Excel.
  • Strong interpersonal and verbal and written communication skills.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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47) Quality Control Analyst 11 – Contract (Massachusetts) 7557

DESCRIPTION:

  • Execute the responsibilities relating to the quarantining, sampling, testing, inspection and disposition of all raw material lots received by the quality control raw materials department. These activities include chemical raw materials, component inspection, and final packaging.  In addition to lot release activities, a QC Analyst II is expected to participate in the mentoring and training of new analysts.
  • Demonstrate proficiency in a task by the completed of an on the Job Training.  
  • Maintain proficiency training per curricula on all governing procedures.
  • Perform all aspects of responsibilities as it pertain to  release activities that will include but is not limited to the quarantining, sampling, testing, and disposition of raw materials and final packaging/component lots.
  • Support additional areas of QCRM including Rejected, Quality Hold, and Non-conforming materials.
  • Perform all activities adhering to strict cGMP guidelines.
  • Maintain on-time completion of all training requirements.
  • Perform simple laboratory instrument up keep including the cleaning, calibration, and the preventive maintenance of the instrument as outlined within the departments governing procedures.
  • Perform high level troubleshooting activities.
  • Participate in audit readiness.
  • Mentor and Train junior analysts.
  • Participate in department initiatives to support the continuous improvement of the quality systems of the QC Raw Materials department.
  • Practice safe work habits and adhere to safety procedures and guidelines.

EXPERIENCE AND QUALIFICATIONS:

  • Experience with raw materials inspection and disposition.
  • Experience working within a cGMP environment.
  • Ability to prioritize and successfully manage multiple competing activities.
  • Flexibility and ability to adapt to a dynamic work environment.
  • Work independently with direction from management.
  • Able to work in a fast paced environment
  • Strong customer service orientation
  • Experience with Lims, Trackwise, MFG/PRO and Microsoft office
  • Experience working in a laboratory setting
  • Experience working in a clean room environment
  • Experience operating a Powered Work Truck (PIT)
  • High School Degree with 4+ years of experience in a cGMP Quality Control department within a FDA regulated industry (drugs, biologics).  Or a Bachelor's degree in scientific related field with 2+ years of experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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48) Quality Control Analyst 1 – Contract (Maryland) 7260

DESCRIPTION:

  • Collate data, perform data entry into MS Excel, and draft quarterly and annual trend reports.
  • Perform routine environmental monitoring and clean utility sampling to ensure that environmental classifications are met.
  • The person will need to assist in cleaning and organizational tasks in order to prepare the QC laboratory and office areas for audits and regulatory inspections.

EXPERIENCE AND QUALIFICATIONS:

  • Environmental monitoring using air particulate counters
  • Surface and air sampling for viable microorganisms
  • Water sampling and bioburden testing
  • Compressed gas sampling
  • Culturing microorganisms
  • Microbial identification using a Vitek
  • Data trending
  • MS Excel and MS Word proficiency required
  • Preferably have QC experience in a biotech GMP environment.
  • B.S. degree in a life science discipline (preferably Microbiology) is desired, but not required if the individual has relevant specific experience in the following:

To apply for a position send your resume to Jobs@JGBBioPharma.com

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49) Clinical Medical Director – Contract (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) GT127M

DESCRIPTION:

  • This position can be done remotely except for very occasional meetings onsite.  
  • The position is needed to start as soon as possible to meet deliverables of Board of Directors (BOD) meetings the end of Oct 2014, February 2015, and budget planning in December 2014. Commitment until the December BOD meeting desired.  Longer term consulting or possible hire to full term possible.
  • Help with strategic long range planning to determine the research and business direction (e.g. line extensions, in-license products, 2nd generation products) of future pipeline.
  • For specific indications help determine the clinical path forward with clinical scenario planning (trial designs, final endpoints, regulatory strategy).
  • Identify KOLs
  • Conduct research on previously done trials and to understand the landscape of the clinical indication.
  • If possible, determine timing of clinical trials (e.g. projected launch date) and cost of clinical trials.
  • The deliverable will be a report / presentation on the above.  
  • May be asked to present at next BOD meeting.

EXPERIENCE AND QUALIFICATIONS:

  • Minimum of 15 years experience working in a clinical science /Clinical research position for the pharmaceutical industry with a minimum title of Director
  • MD preferred; Other degrees combined with relevant experience will be considered
  • Experience talking with and presenting to senior staff at all levels (e.g. VPs and C-level staff)
  • Thorough knowledge and understanding of the pharmaceutical development process

To apply for a position send your resume to Jobs@JGBBioPharma.com

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50) Clinical & Research Assay Team Leader (Manager, Assoc Director, Director) – Full Time (South Korea) TG144F

DESCRIPTION:

  • Position is located in South Korea.  Relocation and work permits will be provided.
  • Reports to the Chief Technical Officer and President of R&D
  • Leads a team of bioanalytic researchers to bioanalytical testing, data management, analysis and report writing, performed in accordance with GLP guidelines.
  • Manages scientific design, development, and qualification of assays and sample testing conducted by laboratory personnel (e.g. cell-based, QPCR, ELISA, histology, etc.) to measure PK/PD, immune response and viral shedding in individuals/animals treated with oncolytic viruses.
  • Selects methods and write protocols for assay development; determine methods of quantitation and assay acceptance criteria; write development reports; write clinical analytical methods. Manages the transfer to and conduct of assays at commercial CROs for clinical studies as needed.
  • Ensures timely delivery and accurate analysis of test results.
  • Authors, reviews, and/or finalizes applicable assay documents, such as SOPs, bioanalytic methods, and study reports in area of expertise.
  • Responsible for personnel scheduling in the Assay Department. 
  • Works with management to ensure employees are qualified for corresponding job responsibilities and plans and implement assay team trainings.
  • Coordinates assay team to synergize with Discovery & Engineering (D&E) Research team activities, in association with the D&E Research team leader.
  • Coordinates assay team with Clinical Operations for proper management of sample collection and inventory: writing of technical PK/PD collection & processing manuals; creation and distribution of PK/PD collection kits; and ensuring chain-of-command of clinical samples is recorded and inventories are accurate.
  • Give scientific support to CMC bioanalytical group and QC as needed.
  • This position will have travel to the US ~ 2 weeks a quarter.

EXPERIENCE AND QUALIFICATIONS:

  • Ability to communicate fluently in both English and Korean
  • PhD in relevant field (molecular biology, biochemistry, cell biology, immunology, etc.) with minimum of 5 years of industry experience, or equivalent.   
  • Experience in assay development and validation in an industrial setting. 
  • Experience in cancer biology, virology, biologics, and animal studies is desirable.
  • Project management and experience managing a laboratory are desirable.
  • Excellent analytical, technical document writing and data management skills are required.
  • Ability to establish and maintain good relationships and effective communication is necessary.
  • Ability to be flexible and innovative and to work quickly and efficiently in a growing biotech start-up environment is necessary.
  • Experience working in a GLP environment. Expertise in developing and optimizing assays in accordance with GLP regulations and Bioanalytical Method Validation guidances as applicable.
  • Expertise in various analytic instruments (HPLC, FPLC, fluorescence microscope, spectrophotometer, fluorometer, liquid scintillation counter, gamma counter, luminometer, Muse Cell Analyzer, etc.)
  • Skill in cell-based assays, virus propagation and purification, QPCR and PK and immunogenicity assays for biologics.
  • Computer proficiency (Microsoft Office, Gen5, GraphPad Prism, JMP and other biochemical analytical software).
  • Ability to work cross-functionally and with international organizations.
  • Strong sense of responsibility, accountability, and integrity.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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51) Manufacturing Technician II – Contract (Massachusetts) 0599

DESCRIPTION:

  • This position is for GMP protein purification.  
  • Operates manual purification manufacturing equipment under close supervision in accordance with current GMPs or standardized procedures and within safety guidelines. 
  • Requires good documentation skills and attention to detail. 
  • Tasks to be completed may include protein purification, preparation of bulk solutions, aseptic fills of buffers, filling and labeling of vials under sterile and non-sterile conditions, routine buffer preparation, filtration, vial preparation and sterilization. 
  • Operates general manufacturing equipment in strict accordance with SOPs to complete tasks as noted above. 
  • Brings deviations in process protocols to supervisors attention. 
  • Maintains all associated documentation for operations being performed. 
  • Reviews and records physical inventory of stock items. 
  • Receives detailed instructions on all work. 
  • All activities are closely supervised and work is reviewed upon completion. 
  • Receives general instructions on new work, which is generally reviewed upon completion.  

EXPERIENCE AND QUALIFICATIONS:

  • Experience: 3 to 6 years
  • Protein purification experience preferred.
  • AS degree or Biotech certificate  in related discipline.  
  • High School diploma with relevant experience considered.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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52) Manufacturing Assistant 1 – Contract (New Jersey) 7147

DESCRIPTION:

  • Follows standardized procedures under close supervision in performing assigned unit operations necessary to support production. 
  • Performs routine tasks in the areas of equipment preparation, buffer preparation, media preparation, labeling, fill and finish. 
  • Prepares and autoclaves equipment for tissue culture, purification and filling. 
  • May serve as witness of routine unit operation tasks for batch record signing. 
  • Maintains all associated documentation for operations being performed. 
  • May take physical inventory of stock items and chemicals. 
  • Requires very few, if any of the requisite skills to perform the required tasks of the position at this level. 
  • Receives detailed instructions on all work. 
  • All activities are closely supervised and work is reviewed upon completion 

EXPERIENCE AND QUALIFICATIONS:

  • Experience: 0 to 3 years.
  • Electro-mechanical skills and/or GMP skills a plus.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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53) Vice President, Research and Development – Full Time (New York) T143BR

DESCRIPTION:

  • Work closely with the senior leadership team to set short, medium, and long-­term goals for the research team in the context of larger business milestones
  • Managing the day-­to-­day activities of a diverse team of biologists, bioinformaticians, and data scientists to ensure that goals are met
  • Prioritize and translate research discoveries in a clinical and business context
  • Help develop a culture of leadership, mentorship, and collaboration
  • Take the lead in developing presentations and publication ready papers
  • Developing  and managing  a  budget
  • Participate in fundraising efforts (government grants, private capital)

EXPERIENCE AND QUALIFICATIONS:

  • Managing collaborative and interdisciplinary research projects
  • Managing, coaching, mentoring and motivating employees for exceptional performance
  • Managing operations in an industry setting or senior academic post (core facility leadership/laboratory head)
  • Communicating research findings through lectures and publications
  • Developing a budget and participating in fundraising efforts (government grants, private capital)
  • Proficiency in the fundamentals of genetics, genomics, statistical analysis, and data science
  • Strong organizational, written, and communication skills
  • Good analytical and problem solving abilities
  • A proven publication record
  • Experience in genetic biomarker discovery research
  • Experience in reproductive biology or early development is highly preferred
  • Enjoys working in a highly collaborative environment with a diverse team to tackle complex problems
  • Is disciplined and driven to deliver ongoing research results
  • Has a positive attitude with a willingness to roll up their sleeves and do what it takes to get the job done
  • Highly organized
  • Strong written and verbal communicator
  • MD or PhD in the Biological Sciences or a related field

To apply for a position send your resume to Jobs@JGBBioPharma.com

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54) Purchasing – Contract (Maryland) 73V0634

DESCRIPTION:

  • Duties will include ordering material through MRP to support production needs. 
  • Maintain continuous material availability and minimize inventory.
  • Negotiate the purchase of materials, equipment and supplies from suppliers.   
  • Solicit quotations for materials and services, analyze bids for specification compliance, pricing, delivery commitments, and evaluate the sources to ensure they can sustain providing goods and services.
  • Monitor supplier and product performance to ensure compliance with contractual obligations.
  • Negotiate delivery, terms and conditions, pricing, and expedite/follow through on receipt and payment.
  • Communicate effectively with suppliers and management of accounts, problem solve challenges and issues, recommend solutions.   
  • Manage supplier relationships.
  • Maintain databases for supplier and product data as required.

EXPERIENCE AND QUALIFICATIONS:

  • E1 and/or SAP working knowledge is desired. 
  • 2-4 years of purchasing experience  
  • MRP knowledge and ERP experience in a manufacturing environment is required.
  • Computer proficiency required in Outlook, Excel, Powerpoint, and Word is required.
  • Knowledge of procurement processes.
  • Knowledge of business concepts/principles (terms and conditions, transportation, accounting)
  • Basic knowledge of supply chain programs (Consignment, JIT, VMI) and ability to manage project execution of these programs desired
  • ISO or equivalent system and change control (FDA, cGMP) experience desired.
  • Experience in invoice reconciliation and inventory management desired
  • Previous purchasing experience desired

To apply for a position send your resume to Jobs@JGBBioPharma.com

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55) Associate Director, Chemical Development – Full Time (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) TH111J

DESCRIPTION:

  • Reporting to the Senior Director, the incumbent will work on all process chemistry aspects of new small molecule pharmaceuticals 
  • Coordinate process development and optimization at a CMO 
  • Verify process manufacturing documentation from a CMO to assure technical and cGMP compliance 
  • Responsible for designing, overseeing and proving (in the lab by self or by directing activities of direct report or managing through contract with outside firm) the development and optimization of synthetic organic processes to new small molecule drug substances 
  • Responsible for timely preparation and/or supply of API, reference intermediates, drug substance reference material, impurities, and degradation products of appropriate quantity and quality of small molecules in development
  • Regularly report work status to supervisor and writes technical reports as needed for project work
  • Draft and/or review regulatory CMC submissions and briefing documentation
  • Cooperatively work with department team and teams outside department including Analytical Development, Medicinal Chemistry, Formulation Development, QC, QA, and Regulatory Affairs 

EXPERIENCE AND QUALIFICATIONS:

  • At least 12 years of small molecule API development experience developing and optimizing chemical processes 
  • Prepared technical regulatory submission documentation (such as IND, IND update, NDA, briefing documentation, and/or international equivalent) associated with API chemical manufacturing 
  • Team player with demonstrated leadership skills
  • Excellent written and oral communication skills
  • Able to design synthetic routes to defined compounds 
  • Able to lead, mentor and manage activities of PhD direct reports 
  • Hands-on experience with laboratory experimentation, pilot plant scale-up and/or larger scale chemical synthesis 
  • Knowledge of the CMO industry and commercial sources of materials 
  • Knowledge, understanding and application of cGMPs
  • PhD in synthetic and/or mechanistic organic chemistry 

To apply for a position send your resume to Jobs@JGBBioPharma.com

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56) Associate Scientist II - R&D – Contract (Maryland) 73P5454

DESCRIPTION:

  • Conduct routine/designed scientific or engineering experiments (may be pre-designed) using laboratory equipment and calculations. 
  • Plan use of equipment, materials and own time. 
  • Assist or on occasion drive the evaluation and procurement of equipment and materials. 
  • Understand the new product Introduction process and impacts business opportunities through successful task completion. 
  • Make detailed observations and analyze data. 
  • Maintain accurate lab notebook and training file in accordance with division standard. 
  • Advise supervisor of factors that may affect quality, accuracy, timeliness and usefulness of data. 
  • Assist supervisor in the interpretation of experiment results. 
  • Advises supervisor of factors that may affect experiment; suggests additional experiments. 
  • Suggest options for additional experiments. 
  • Plan well understood technical options to reach a specific technical objective. 
  • Troubleshoots experiments. 
  • Identify and solve elementary problems in experimental designs. 
  • Contribute ideas and suggestions to improve standard laboratory techniques, improve protocols, processes and equipment. 
  • Lead the documentation of repeatable lab procedures as required. 
  • Read literature directly associated with assigned project. 
  • Maintain some familiarity with competitive products and assist with competitive audits or documentation as required. 
  • Comply with all company safety regulations and procedures. 
  • Report non-compliance and may serve as team lead. 
  • Suggest improvements in safety and productivity based on solid technical understanding of expected R&D outcomes. 
  • May be required to perform other related duties as required and/or assigned. 
  • Position exercises judgment within defined procedures and practices to determine appropriate action. 
  • Performs duties independently with only general direction given on routine work. 
  • Receives detailed instruction on new assignments or in the design of experiments. 
  • Ability to appreciate importance of project toward the objectives. 
  • Job encounters recurring work situations with occasional variations from the norm, involving a moderate degree of complexity. 
  • Works on problems where analysis of situation or data requires a review of multiple identifiable factors. 
  • Accuracy is required in performing all functions of this position. 

EXPERIENCE AND QUALIFICATIONS:

  • Mammalian cell culture
  • Transient protein expression
  • Cell culture media development
  • Lab organization
  • Requires a Bachelor's degree in Biology, Chemistry, Biochemistry, or other related discipline, or the equivalent knowledge and experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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57) Human Resources Administrative Assistant – Contract (Massachusetts) 3120

DESCRIPTION:

  • Performs a variety of administrative and general business activities to maintain and support the efficient operation of the HR department.  
  • This position reports to the Director, Human Resources.  
  • Responsible for performing general and human resources-related administrative tasks including but not limited to: calendar management, customer service, filing, processing of employee data changes/forms, collecting data and preparing related HR statistics/reports, and other necessary administration support as needed.  
  • The role has responsibility for managing highly confidential information requiring the use of tact and discretion and will provide guidance to all levels of employees regarding human resources practices and procedures.  
  • The role will utilize the SAP and payroll systems to perform critical activities
  • Direct employees to find HR resources and support resolution of payroll issues.
  • Gather data and preparing reports – extracting data from existing information, creating others as necessary.
  • Provide support to HR preparing work employee transactions.
  • Conduct new hire orientations

EXPERIENCE AND QUALIFICATIONS:

  • 2+ years administrative experience preferably in the HR field.        
  • Experience at a manufacturing facility is a plus.
  • Experience at a biotech is a plus.
  • Proficient in utilizing hardware, software and web applications to perform various administrative activities and assist customers. 
  • Demonstrates proficiency in information retrieval from various HR systems.
  • Works efficiently in a complex and demanding environment while maintaining a professional attitude and demeanor.
  • Manages time and logistics for customers supported including resolving conflicts, being decisive exercising sound business judgment and coordinating schedule with other internal/external executives.
  • Displays sense of urgency.
  • Strong MS Office proficiency.  
  • Ability to create and maintain key metrics on reports of a moderate complexity.
  • Ability to communicate effectively with all levels of the organization and across sites.
  • Ability to work with minimal direction.
  • May participate in new hire orientation-must be comfortable speaking in front of an audience.
  • Minimum of HS diploma with preference for those with additional formal education (i.e. certificate or degree).  

To apply for a position send your resume to Jobs@JGBBioPharma.com

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58) Quality Control Analyst 1 – Contract (New Jersey) 3218

DESCRIPTION:


  • Required to be gown certified for Grade A through D areas. 
  • Perform environmental monitoring of viable and non-viable particle sampling and surface/personnel sampling before, during and after production operations

EXPERIENCE AND QUALIFICATIONS:

  • At least one year of relevant post-degree work experience in Environmental Monitoring, Aseptic Manufacturing or Microbiological laboratory operations.
  • Evidence of good oral and written communication skills
  • Effective presentation of concepts and ideas
  • Interpersonal and conflict resolution skills. 
  • Attention to detail, flexibility and an awareness of production and attendant quality control problems.
  • Basic understanding of GMPs and of regulatory requirements as they apply to the sterile pharmaceutical device and drug or related fields. 
  • Bachelor's degree in Microbiology or Biology is preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

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59) Training Specialist – Contract (Massachusetts) 9011

DESCRIPTION:

  • Responsible for performing a variety of complex tasks under general guidance and in accordance with current GMP's. 
  • Work closely with manager to ensure LMS activities, reports, curricula, metrics are completed successfully. 
  • Under the guidance from the manager work with data entry colleagues to ensure all activities for the LMS are completely accurately and in a timely manner.
  • Supports LMS functions and data Integrity for the site having full administrative rights and access.
  • Oversee development of curricula requirements and manage assignments within the learning management system (LMS) for intended audience.
  • Maintain training records and materials, either paper-based or electronic, for intended audience in accordance with GxP and applicable regulations
  • Set up training sessions on the LMS calendar.
  • Enforces standards and is responsible for quality review, publishing, uploading and version control of electronic training material to the LMS.
  • Manages the train-the-trainer program within the LMS and oversee tracking of qualifications.
  • Administers other training programs as tasked to include scheduling/coordination/notification of required resources (e.g.: Instructors, rooms, equipment, training materials, rosters, etc.)
  • Prepare LMS training materials and eLearning computer-based training modules to support site training efforts.
  • Assists with New Hire Orientation set up and preparation as needed.
  • Other duties as assigned.

EXPERIENCE AND QUALIFICATIONS:

  • Prior experience with learning management system preferably Plateau
  • Advanced Microsoft Office experience required, especially Excel
  • Ability to multitask with strong time management skills
  • High attention to detail and accuracy
  • Bachelor's Degree

To apply for a position send your resume to Jobs@JGBBioPharma.com

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60) Senior Manager, Clinical Site Budget Negotiation – Full Time (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) TC111W

DESCRIPTION:

This person will be a member of the contracts and outsourcing team. Will manage the team that draft, and negotiate clinical budgets and administer non-disclosure agreements with sites. Will manage the process and workflow of site contracts, ensure compliance with existing agreements, and ensure the proper routing of documents for execution by corporate officers and perform other duties as assigned. This position reports to the Senior Director, Clinical Contracts and Outsourcing.

  • Manage the process of drafting, negotiation and tracking status of clinical trial budgets, tracking status of CTA negotiation coordination with legal and confidentiality agreements
  • This role will require performing some of the negotiation as well as management of the team.
  • Review the budgets that have been negotiated by the team members and ensure that they are accurate and compliant with company policies and best practices.
  • Manage and mentor the staff
  • Prepare, format and finalize some site CTAs for execution
  • Work with Legal document-tracking database
  • Monitor contracts for compliance with Company and department policies
  • Liaise with legal for review of CTA
  • Draft and establish processes for document flow, and train others on procedures

EXPERIENCE AND QUALIFICATIONS:

  • At least seven (7) years of site budget and contract negotiation experience
  • Minimum of five (5) years of experience in a contract administration environment in a pharmaceutical, CRO or biotech company
  • Strong Excel and math skills required
  • Broad knowledge of general pharmaceutical contract law, regulatory law and policies relevant to clinical contracts (healthcare compliance, GCP, CFR)
  • Excellent negotiation and written/verbal communication skills
  • Ability to work independently and interdependently, as well as manage others
  • Strong creative thinking and problem solving skills
  • Ability to understand the full clinical development process
  • Must have good organization and planning skills, proven ability to handle multiple priorities
  • Must be a leader within the department
  • Proficiency with MS Word, Excel, Access and Outlook required

To apply for a position send your resume to Jobs@JGBBioPharma.com

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61) Drug Safety Associate – Full Time (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) B111MR

DESCRIPTION:

  • Report to the Safety Physician/Associate Director/Director/Senior Director of Drug Safety.
  • Review, track, route, and manage approval process for adverse event reports and other products processed by external vendor and follow up with medical monitors and other study team members as appropriate.
  • Coordinate and facilitate the weekly review of SAEs with medical personnel to assure timely assessment of cases.
  • Act as primary Drug Safety representative for assigned studies and for all safety related activities including participation in the review of drug safety related content for study protocols and amendments, case report forms, safety management plans, clinical study reports, ad-hoc safety reports, investigator brochures, annual reports, data management plans, clinical data review plans, data listing reviews, and all other study documents or activities requiring safety review and input.
  • Ensure compliance with local and international reporting of adverse events throughout the program including reporting to Competent Authorities, Ethics Committees, Institutional Review Boards, Investigators, and manufacturer’s.
  • Facilitate the analysis of similar events and/or risk benefit statement for expedited safety reports occurring in clinical studies.
  • Coordinate and facilitate the monthly review of SAE data for assigned studies with medical personnel.
  • Assist in the identification of safety signals and provision of data analyses and summaries including assisting in responding to queries from health authorities, partners, or others.
  • Support the product safety group with tables summarizing AEs, SAEs, and narratives of particular events of interest for the programs.
  • Facilitate SAE reconciliation.
  • Assist with department projects as needed including but not limited to electronic case file reconciliation of legacy cases.

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor’s degree in biological sciences or health care professional (e.g. nurse, pharmacist and etc.), and at least 3 years of Drug Safety experience.
  • Three years recent and relevant experience in Drug Safety case processing and reviewing of safety data
  • Recent experience using drug safety database (e.g. ARISg or Argus)
  • Recent experience using MedDRA and WHO-DRUG dictionaries
  • Working knowledge of FDA and international pharmacovigilance and clinical safety regulations and guidelines
  • Experience with the content of pharmacovigilance documents such as SOPs, guidelines, safety plans
  • Experience with exchanging international safety data with foreign business partners or affiliates
  • Exposure to developing and implementing signal detection activities
  • Ability to independently identify problems and effectively offer solutions
  • Excellent written, oral communication, personal organizational skills and resourcefulness
  • Ability to work collaboratively as part of a team in a fast-paced challenging environment
  • Proven proficiency using MS Word, Excel, PowerPoint and Outlook

To apply for a position send your resume to Jobs@JGBBioPharma.com

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62) Lab Animal Technician II – Contract (Massachusetts) 4994

DESCRIPTION:

  • Responsible for ensuring the health and well being of laboratory animals through the performance of animal husbandry and technical services while ensuring compliance with all applicable regulations and corporate policies and procedures. 
  • Assists researchers in the performance of more complex laboratory procedures. 
  • Provide animal husbandry services according to established procedures including monitoring and evaluating animal health, reporting abnormal conditions, monitoring and providing simple and complex clinical treatments as directed by a veterinarian, LAPM or designee. 
  • May also diagnose and determine a course of treatment under the direction of a veterinarian or LAPM. 
  • Provide environmental enrichment, ensuring constant availability of food and water, and sanitation. 
  • Ensures compliance with GLP, USDA, AAALAC-I, AWA, OSHA, and other applicable regulations or guidelines and with company policies and practices on animal care and research security and may include interacting with inspectors and representatives of enforcement agencies. 
  • Ensures the accurate and timely keeping of records and documentation on activities. 
  • Applies emergency medical knowledge as necessary with a priority of maximizing data gain and minimizing animal loss. 
  • Provides guidance and direction for less experienced staff. 
  • Demonstrated ability in the application of requisite skills and applies additional skills and knowledge acquired through experience to perform the more complex tasks of the position. 
  • Generally receives no instructions on routine assignments while under little or no supervision. 
  • Receives general instructions on new work, which is generally reviewed upon completion. 

EXPERIENCE AND QUALIFICATIONS:

  • Good communication and customer service skills
  • Minimum of 1 year experience with basic rodent husbandry and technical skills preferred.
  • AA or equivalent experience in Animal Science, Biology, Veterinary Technology or related field and 1-3 years experience with laboratory animals preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

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63) Document Control Clerk – Contract (San Francisco Bay Area) 2092P73

DESCRIPTION:

  • Process controlled documents to ensure the most current document is available for use. 
  • Formatting word documents
  • Updating revision history
  • Logging Document Change Control Requests (CCRs) into tracking database 
  • Posting the most current document on the controlled drive so everyone has access. 
  • Filing CCR forms and documents
  • File other quality documents as needed (e.g. batch records, COAs, COOs, etc.) 

EXPERIENCE AND QUALIFICATIONS:

  • Experience coordinating or managing projects in a learning environment
  • Knowledge of Windows, Power Point, Word and Excel or similar programs required
  • Knowledge of Learning Management Systems and evaluation tools
  • Experience with compliance training programs
  • Ability to communicate professionally with all levels of management
  • College degree strongly preferred  
  • 1-3 years of professional work experience 
  • Attention to details 
  • Self motivated 
  • Eager to learn

To apply for a position send your resume to Jobs@JGBBioPharma.com

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64) Senior Clinical Research Associate – Full Time (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) F82JM

DESCRIPTION:

Manage assigned activities of clinical study to ensure it is completed on time, within budget, and in compliance with Good Clinical Practice (GCP), government regulations, and overall clinical objectives.  Responsible for quality study oversight, including but not limited to monitoring, oversee clinical vendors, and review trip reports. Participate in the training and development of lower level CRAs. 

  • Daily activities will vary depending on the clinical phase of the program.  Will have responsibilities for managing more than one project.  Determine methods and procedures for performing new assignments.  Provide mentorship to CTAs and CRAs.
  • Conduct monitoring and oversight of products to verify study data on source documentation and case report forms (CRFs).
  • Manage contract research organization (CRO) personnel and study sites to ensure compliance with the protocol, GCPs, FDA regulations, ICH/GCP guidelines, SOPs, and overall clinical objectives; and to ensure data discrepancies and site/manage all study parameters including, but not limited to, clinical study start-up activities, clinical supplies preparation, enrollment, data collection, and close-out.  
  • Participate in the development of study-related clinical documents including, but not limited to, informed consent forms, site training materials, CRFs, clinical monitoring plans, source document templates, and data audit worksheets.
  • Participate in the evaluation and selection of sites and CROs, and planning of clinical meetings (investigator meeting, steering committee meeting, CRO meetings, etc.)
  • Broad knowledge of FDA and ICH regulatory requirements. 
  • Assist in the preparation of study protocols, IBs, and regulatory submissions.
  • May represent clinical operations in project team meetings.
  • Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
  • Travel is required – up to 50%

EXPERIENCE AND QUALIFICATIONS:

  • BS, RN/PA, BSN degree or equivalent, with 8+ years of clinical research experience, of which at least 6 years must be onsite monitoring experience.
  • Experience in one or more of the following therapeutic areas preferred:  inflammation, infectious disease, and/or oncology.
  • Broad knowledge of GCPs, ICH, and FDA regulatory requirements governing human clinical trials.
  • Proven ability to exercise independent judgment, use critical-thinking to analyze problems which may require multiple factors and approaches.  
  • Excellent technical writing skills.
  • Proven experience working in cross functional project teams.
  • Excellent communication and interpersonal skills.
  • Computer proficiency.
  • Flexibility and integrity
  • Experienced with successfully juggling multiple teams, external sites and projects in a dynamic environment
  • Proactive in spotting potential problems and seeking successful solutions
  • Action and goal oriented
  • Practical approach to clinical and regulatory processes
  • Good judgment and decision-making experience
  • Collaborative and team-oriented
  • Excellent attention to detail

To apply for a position send your resume to Jobs@JGBBioPharma.com

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65) Regulatory Affairs Manager – Full Time (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) G125RY

DESCRIPTION:

The Regulatory Affairs Manager is responsible for ensuring that new products and changes to products are prepared and submitted in a timely manner to Regulatory Agencies in all targeted markets, interfacing with cross-functional development teams and Regulatory Agencies.

  • Prepares and supports regulatory submissions in a timely manner meeting current regulations and guidance document requirements
  • Primary contact and representative for all interactions with Regulatory Agencies for assigned projects
  • Participates on project teams representing Regulatory Affairs to provide inputs and answer questions related to regulatory requirements
  • Ensures regulatory milestones for assigned projects are met
  • Prepares regulatory strategies for development products to determine regulatory pathways to market including FDA. Communicates regulatory strategy and updates, as necessary, depending upon new information generated during development
  • Reviews product labeling to assure compliance with regulatory requirements
  • Ensures working knowledge of assigned products, including claims and associated requirements, in order to perform adequate reviews and compliance with standard operating procedures
  • Interprets and applies FDA and International regulations to business practices and provides regulatory input, advice and guidance to the organization
  • Monitors, tracks and actively assesses evolving FDA regulations, guidances, points-to-consider, warning letters and policies
  • Monitors current developments and potential changes and opportunities in the US and other regulatory jurisdictions

EXPERIENCE AND QUALIFICATIONS:

  • Bachelors Degree in Science or related field
  • At least 5 years experience in managing Regulatory Affairs in a pharmaceutical company
  • Experience working with FDA and International regulations
  • Experience filing submissions in the US and International markets
  • Demonstrated communication and presentation skills
  • Demonstrated attention to detail and organizational skills
  • Ability to lead a team, influence other and handle increasing levels of responsibilities
  • Ability to build relationships between Regulatory Affairs and other areas of the organization
  • Certifications such as RAC (US); Member of RAPS (Regulatory Affairs Professional Society) preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

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66) Administrative Assistant 1 – Contract (New Jersey) 0037

DESCRIPTION:

  • Receives detailed instructions on work and generally works under minimal supervision.  Work is generally reviewed upon completion. Need to learn and understand the various manufacturing processes at the site to allow for appropriate planning while monitoring available labor resources, work centers and performance to schedule.
  • Interacts and supports manufacturing, QA/QC, R&D groups with respect to planning activities
  • Assist with scheduling production activities for various manufacturing processes when needed to meet the monthly plan
  • Routinely review the system generated orders in the system and makes the necessary decision based on production needs to adjust the orders with revised dates, quantities, or resources.
  • Responsible for managing inventory for specific items where individual will monitor inventory and ensure in process material is readily available for production use
  • Assist with the distribution of labeling materials required for production activities, i.e., print identification labels, sample labels.  Perform movement transactions in system for component transfer to appropriate locations. 
  • Perform cycle count of labeling materials
  • Coordinate with planning and warehouse when labeling materials will be needed for production based on the schedule.
  • Process related transactions
  • Create work orders for production
  • Prepares production records for manufacturing
  • Assist with Bill of Material auditing for accuracy
  • File documents accurately
  • May provide clerical support as necessary, including filing, faxing, copying, performing data entry, etc.
  • Completes other duties as requested.

EXPERIENCE AND QUALIFICATIONS:

  • Excellent organization skills and have a high attention to detail 
  • Strong Excel, Power Point, Microsoft Outlook skills
  • Strong writing and communication skills
  • SAP experience a plus
  • HS Diploma

To apply for a position send your resume to Jobs@JGBBioPharma.com

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67) Verification Specialist Reimbursement – Contract (Massachusetts) 1565

DESCRIPTION:

  • Responsible for accurate entry of patient information into department database for individual and multiple patient assistance applications and insurance verifications
  • Triage all incoming faxes and workload via Microsoft Outlook  to ensure all patient assistance and verification requests are entered into the database and distributed appropriately
  • Process patient assistance applications and communicate results to healthcare providers
  • Troubleshoot and resolve reimbursement related issues with team members and insurance companies
  • Maintain a proficient understanding of the Medicare Part D Benefit, Medicaid, and commercial prescription drug plan benefits

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor or Associate’s Degree preferred.
  • Spreadsheet and database skills.
  • Proficient typing skills.
  • Basic understanding of health insurance benefits and reimbursement.  
  • Must be able to multitask and learn reimbursement related concepts quickly.  
  • Must have excellent communication skills and ability to thrive in a team environment.  

To apply for a position send your resume to Jobs@JGBBioPharma.com

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68) Quality Inspector II – Contract (New Jersey) 0247

DESCRIPTION:

  • Monitors and/or performs inspection and control of products and materials. 
  • Performs product and/or component inspections in accordance with specifications and SOP's. 
  • Samples, inspects, and releases components and raw materials as per SOP's and specifications. 
  • Monitors various stages of processing along with the appropriate paperwork in compliance with specifications. 
  • Maintains raw materials, in-process and finished goods retain storage areas. 
  • May conduct simple testing in accordance with defined standard operating procedures. 
  • Contact with outside vendors as necessary. 
  • Demonstrated ability in the application of the requisite skills to perform the required tasks of the position. 
  • Receives general instructions on routine assignments under general supervision. 
  • Receives detailed instructions on new work, which may be closely supervised and reviewed. 

EXPERIENCE AND QUALIFICATIONS:

  • High School Diploma or equivalent
  • Previous GMP experience required (2 plus years)
  • Ability to use hand held measuring devices such as calipers, rulers, micrometers and boregauges to evaluate incoming components
  • Ability to follow AQL sampling plans as specified by internal SOPs
  • Ability to sample water and chemicals/raw materials as specified by internal SOPs
  • Perform incoming visual and dimensional inspections of packaging components and product literature
  • Perform line clearances as required by internal SOPs and batch production records (BPRs)
  • Experience 3-6 yrs.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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69) Laboratory Analyst 1 – Contract (Pennsylvania) 9302

DESCRIPTION:

  • Perform and report results of sample testing as assigned in analytical immunology. 
  • Participate in the development and performing of assays including but not limited to Immunodiffusion assays, cell-based potency assays, antibody based assays such as ELISA
  • Maintain records and test results following good manufacturing practices (GMP)
  • Document work clearly and perform tests accurately
  • Perform tasks in a repeatable and efficient manner
  • Communicate effectively with team members and client staff 

EXPERIENCE AND QUALIFICATIONS:

  • At least six months related laboratory experience in a GMP laboratory
  • General laboratory skills, including experience with pipettes, measuring and preparing solutions, calculating dilutions.
  • Bachelor of Science in biology, cell biology or related science

To apply for a position send your resume to Jobs@JGBBioPharma.com

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70) Analyst II - Finance – Contract (Massachusetts) 9507

DESCRIPTION:

  • Contributes to the financial success by providing a variety of financial services.  
  • Implements the financial planning, project tracking, project proposals and costing and re-invoicing, monthly closing and accounting controls processes.  
  • Participates in decision support analyses in support goals and objectives.  
  • Monitors actual results compared to plan, forecasts and other established criteria and develops corrective action plans where appropriate.  
  • Identify, analyze and recommend opportunities for improvement, financial policies and controls for compliance.  
  • Manages the execution of the financial project management system
  • Responsible for planning, forecasting and reporting of expenses, period costs, capital, and headcount
  • Provides tracking and calculation of project financial and resource projections, costs
  • Prepares financial analyses in support of expense management for development
  • Prepares operational budget with department director and reports progress
  • Responsible for the reporting projects tracking
  • Responsible for oversight of the management by project system  and in collaboration with other locations.
  • Assures timely and accurate recording, reconciliation, and reporting of monthly financial information
  • Act as interface to local purchasing and legal department

EXPERIENCE AND QUALIFICATIONS:

  • Generally accepted cost accounting principles
  • General knowledge of pharmaceutical processes and the financial implications
  • Business acumen for reporting relevant financial data
  • Verbal and written communication
  • Effective decision making skills
  • Strong computer aptitude including advanced use of Microsoft Excel and moderate knowledge of Microsoft Powerpoint, Word
  • Ability to work transversally in a matrix organization
  • Bachelors Degree in Finance or Accounting, specialization in cost controlling is welcome
  • 2-3 years cost accounting experience
  • 2-3 years Financial accounting reporting with increasing complexity
  • 2-3 years variance analysis with increasing complexity and limited supervision

To apply for a position send your resume to Jobs@JGBBioPharma.com

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71) Clinical Project Leader II – Contract (Pennsylvania) 0015

DESCRIPTION:

  • Responsible for managing identified research and/or analytical projects. These responsibilities include planning, feasibility evaluation, budgeting, execution, and closeout of said delegated research and/or analytical projects. Coordinates as appropriate with other groups, entities, or platforms within commercial operations in order to ensure timely tracking and completion.  
  • Responsible for the timely and accurate completion of tasks assigned to them as part of their role
  • Actively participates as a member of the team with particular attention to managing/coordinating the planning, feasibility evaluation, budgeting, execution, and closeout of assigned research and/or analytical projects.
  • Builds effective relationships and networks to include but not limited to other groups, entities, or platforms within commercial operations and globally, and with any external partners or suppliers involved in the assigned research and/or analytical projects.
  • Participates in the formal review of all documents required to initiate, execute, or conclude assigned research and/or analytical projects, including regulatory documents if applicable.
  • Attends and/or chairs all meetings of operational or cross functional teams acting in support of assigned research and/or analytical projects.
  • Provide numerical data if available to describe the size of the job, or its impact on the business. Use annual figures and specify currency. Figures should include budgetary responsibility, purchasing authority, resources available. Highlight the key decisions made in this job. Outline the sphere of the job, such as whether the accountabilities are global, country specific, or function specific.

EXPERIENCE AND QUALIFICATIONS:

  • Demonstrated ability to work with substantial independence in managing research or analytical projects. 
  • Facility with the basic document and data management digital tools. 
  • Training or experience in such areas as GCP methods, clinical trial management, data management or analysis, and CBER regulatory document requirements are indicative of the background necessary for success in this position.  
  • Also important are good interpersonal skills – ability to work with individuals at different levels; Independence, self-motivation; strong team worker; resourcefulness; ability to find solutions to operational problems.
  • BA/BS in Biology, Life Science, or related field of study;  3-5 years relevant industry experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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72) Staffing Coordinator – Contract (New Jersey) 0563

DESCRIPTION:

  • Responsible for the scheduling of candidate interviews and handling all communication with candidates and internal stakeholders.  
  • Partnering with recruiters on candidate information, securing interviewer availability, coordinating with clients or other administrative individuals, coordinating interview panels, and managing associated logistics with regards to interview locations/conference rooms
  • Managing candidate communications to ensure smooth execution of interview
  • Work closely with multiple recruiters on offer letters and candidate on-boarding requirements
  • Manage candidate travel requirements and expense reimbursement

EXPERIENCE AND QUALIFICATIONS:

  • Be able to work in a high volume environment with a high-energy team of professionals. 
  • This role will also include project work as it pertains to interview coordination for large-scale staffing expansions. 
  • Must be collaborative, working to solve problems and bringing projects to closure with the recruiting team, other scheduling coordinators, and internal stakeholders
  • A project-management mindset, communicating expectations to all customers and keep to an organizational plan.
  • A passion for customer support
  • Must have strong MS Outlook/MS Word experience for interview scheduling, be pro-active, collaborative and have the ability to create partnerships with others in the organization. 
  • Must be well organized, have strong attention to detail, have a sense of urgency, be able to prioritize and effectively work with a diverse group of people at all levels within the organization. 
  • Experience in a related role, with heavy calendar management and support of multiple stakeholders
  • Very strong attention to detail and ability to multi-task priorities
  • Organizational and time management skills
  • Professional verbal and written communication
  • Positive attitude and strong collaboration capability
  • Preferred prior experience with Taleo or other Applicant Tracking Systems
  • HS Diploma required, Associated Degree preferred; 2-4 years in administrative role

To apply for a position send your resume to Jobs@JGBBioPharma.com

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73) Associate Director, Clinical Regulatory – Full Time (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) A113KZ

DESCRIPTION:


  • Position focuses on clinical and nonclinical aspects of domestic and international regulatory affairs for multiple projects. Leadership in the strategy and implementation of development programs; management of internal regulatory staff; representation in corporate relationships regarding regulatory affairs; and other duties as assigned.
  • Lead regulatory team in establishing global regulatory strategy for development programs
  • Oversee planning, preparation, and submission of BLA’s and NDA’s
  • Oversee planning, preparation, and submission of INDs and international equivalents
  • Oversee IND maintenance and the submission of all amendments
  • Provide strategic insight to the project team regarding product development
  • Communicate with regulatory consultants regarding product development plans
  • Manage interactions with FDA or other regulatory health authorities
  • Manage multiple regulatory staff members
  • Other duties as assigned

EXPERIENCE AND QUALIFICATIONS:

  • 5-7 years experience in Regulatory Affairs in the biotechnology industry
  • Skilled at gathering supportive information and developing product approval strategies
  • Proven ability to manage critical projects as a part of a interdisciplinary team
  • Proven ability to successfully interact with regulatory authorities
  • Prior experience managing regulatory submissions with the ability to successfully manage projects to deadlines
  • Thorough understanding of relevant drug development regulations and guidelines
  • Prior experience in a product development role and experience with biologic products is desirable
  • Proficient with computer and standard software programs
  • Outstanding interpersonal and communication (written and verbal) skills
  • Effective task planning and coordination abilities
  • Bachelors of Science in life sciences or other related field.
  • Advanced degree is desirable

To apply for a position send your resume to Jobs@JGBBioPharma.com

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74) Quality Control Analyst 1 – Contract (Massachusetts) 8632

DESCRIPTION:

  • Performs operations necessary for quality testing and plays a role in implementing new technology within quality control. 
  • At more senior levels, provides an investigative or technological orientation in designing, executing, interpreting and validating quality procedures and test methods. 
  • Completes routine testing of raw materials, in-process and final products in accordance with SOPs for product release and validation. Aids in the development of test methods. 
  • Conducts data review and preliminary evaluation of results. 
  • Solves problems using limited predetermined options such as repeating the assay when parameters are not met to determine the cause, etc. 
  • Provides input to the technical composition of operating documentation.  
  • Follows standard practices to obtain solutions. 
  • Contributes to the completion of routine technical tasks. Failure to achieve results can normally be overcome without serious effect on schedules and programs. Contacts are primarily with immediate supervisor and other personnel in the section or group. Experience: 0 to 3 years.
  • Collect and process samples in a timely manner, review laboratory7 assay documentation for accuracy and timeliness, evaluate preliminary results; aids in the development of test methods and participate with the team to meet group goals and perform routine laboratory duties.
  • Perform water, steam, and critical utility collection as well as associated testing.
  • Perform Biological Indicator Testing, Environmental Monitoring, Testing
  • Perform Bioburden Testing of In-Process products, buffers, and water.
  • Receive manufacturing samples into the QC Lab as well as sample retain disposal.
  • Troubleshoot assay and instrument problems with laboratory supervisor.
  • Enter and review data 
  • Perform safety and operational lab audit.
  • Perform general maintenance of lab equipment.
  • Participate in writing and revisions SOPs, protocols.
  • Assist in the development and optimization of testing methods.
  • Maintain log books related to inventory and equipment.
  • Ensure labs are clean and safe (in compliance with cGMP) and properly stocked.
  • Make detailed observations in support of alert, action, and OOS result investigations.
  • Participate in the qualification of equipment, methods, and processes.
  • Participate and perform special studies & projects assigned to microbiology.
  • Perform plate reading, streaking, gram staining, microbial identification.
  • Perform routine QC testing of in-process and final products in a cGMP lab for release.

EXPERIENCE AND QUALIFICATIONS:

  • Associates degree and minimum of 0-2 years industry experience or Bachelor's degree in Life Sciences discipline.
  • 1 year experience in a cGMP lab environment Working knowledge of practices and technique.
  • Proficient in Outlook and MS Work and Excel and lab based data management systems

To apply for a position send your resume to Jobs@JGBBioPharma.com

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75) Manufacturing Assistant 1 – Contract (New Jersey) 7235

DESCRIPTION:

  • Performs the tasks of the production operation specific to aseptic manufacturing.
  • Under supervision, performs the tasks of the production operation specific to aseptic manufacturing and filling.
  • Maintains batch record documentation and logs as required by corporation and regulatory agencies.
  • Performs cleaning and sanitizing of production equipment and classified production space.
  • Prepares, according to procedures, various stock solutions, saline and buffers as required by the production process.
  • Prepares equipment, glassware, filters, etc. required for production.
  • Assists in process and system validation activities as required.
  • Performs product sampling, environmental monitoring, or other related activities as directed.
  • Requires very few, if any of the requisite skills to perform the required tasks of the position at this level.
  • Receives detailed instructions on all work.
  • All activities are closely supervised and work is reviewed upon completion.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Clean room environment for the aseptic production of sterile products.
  • Involves work with hazardous materials.
  • Follows site SOP's to perform the job

EXPERIENCE AND QUALIFICATIONS:

  • Microsoft Office Suite; Pharmaceutical experience is preferred; cGMP experience preferred
  • Bachelor's degree is preferred but not required

To apply for a position send your resume to Jobs@JGBBioPharma.com

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76) CMC Sr. Manager 1 – Contract (New Jersey) 8817

DESCRIPTION:

  • Responsible for performing as the focal point [global leader or regional contact].  
  • Responsible for the global/regional regulatory maintenance of marketed, consumer health care products approved by the US Food and Drug Administration, European Medicines Agency (EMA) Centralized Procedure (CP), National De-Centralized Procedure (DCP) and National Mutual Recognition Procedure (MRP) as well as other National Health Authorities.
  • The scope of activities involves regular maintenance of non-prescription drug products (over the counter, behind the counter) and health care products.  In addition, the scope of activities includes non-R&D life-cycle management projects, territory extensions and licensing activities for these entities.
  • Development of regulatory CMC strategies for IA Q&C CMC changes or Health Authority requirements.  For approved products, the incumbent is additionally responsible to facilitate completion of submission dossiers assure that submission dossiers comply with Conformance regulatory CMC strategies, author and sign (as appropriate) submission dossier application forms and communications and directly interact as liaison with Health Authority contacts (telephone, face-to-face, etc.).
  • Responsible to contribute and/or lead activities involving Global Regulatory Policy (Health Authority Guidelines, External Organization concept papers, leadership at external conferences).  
  • Responsible to contribute to various coordination activities (eg, Quality Documents, key performance Indicators, databases, etc.).
  • Creates collaborative working relationships with Global Regulatory Affairs, Country Affiliate Regulatory Groups, Industrial Affairs (Industrial Development and Innovation, Quality & Compliance), Pharmaceutical Operations, Business Development, Legal, etc)
  • Must display a high level of individual leadership, strategic and technical guidance; and demonstrate behaviors that live and promote the company values.

EXPERIENCE AND QUALIFICATIONS:

  • Experience working in a team environment within a large organization.  
  • A good knowledge of pharmaceutical product development and relevant Health Authority regulations is essential to support registration of consumer health care products and life-cycle management projects.  
  • Must have some knowledge of key Health Authority thinking, anticipatory foresight and be able to assume leadership of projects. Should demonstrate a high level of initiative, some independence in thinking, strategic development, personnel development and be able to communicate effectively to broad sophisticated audiences both internally and externally.
  • BA/BS in a science/health field (eg, Chemistry, Pharmacy, Biology) plus 7 yr industrial experience (chemical, analytical, pharmaceutical, manufacturing) including 4 year in regulatory CMC or advanced degree (MS/MA, PhD) in a science/health field plus 4 year industrial experience including 2 year in regulatory CMC.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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77) Pharmacovigilance Compliance Associate – Contract (Massachusetts) 6205

DESCRIPTION:

  • Contribute to the development, production and maintenance of the appropriate tracking and compliance tools, reports, plans, tasks and activities pertaining to the management of the GPE compliance management system.
  • Perform data entry, deviation closure and reconciliation activities in the global compliance database.
  • Perform follow-up on pending Corrective and Preventive Actions (CAPAs) and ensure implementation of the same in the Global compliance database.
  • Perform compliance data analysis using available tools to identify potential trends
  • Track and communicate on compliance
  • Manage and update compliance documents in the Sharepoint repository
  • Support affiliates on compliance matters as required
  • Support the conduct of PV audits/regulatory inspections
  • Participate to the development of compliance programs and quality tools to enhance GPE global quality and adherence to SOPs and regulations.

EXPERIENCE AND QUALIFICATIONS:

  • Knowledge of Individual Case Safety Reports (ICSR) management processes including case receipt, case processing, medical review and regulatory submission.
  • Knowledge of compliance international regulations and ICH environment foundations
  • Knowledge of safety databases like AWARE, ARGUS etc.
  • Proficiency in Microsoft Excel, Powerpoint, Word, Access, Visio.
  • Knowledge of quality databases, Sharepoint and SQL queries will be a plus.
  • Good analytical/judgment capabilities to understand/analyze/synthesize and communicate
  • Able to manage both time and priority constraints and to manage multiple priorities simultaneously
  • Attention to details
  • Proven ability to work in international environment and cross-functional team, with good interpersonal skills / assertiveness / team spirit / caching skills
  • A Bachelor’s in life sciences or Pharmacy with a minimum of 1-2 years of experience in Pharmacovigilance activities related to ICSRs/periodic reports/Signal detection.
  • In depth understanding of international pharmacovigilance requirements/updates in particular EU/FDA requirements/international guidelines, e.g. ICH/CIOMS, Clinical development methodology and knowledge of Clinical Trial guidelines (GCP) and regulation
  • An additional degree in pharmaceutical regulatory environment, or in business management or in quality management would be much appreciated.
  • Creativity to propose/create/supervise appropriate tools to support business activity
  • Writing quality documents
  • Project/time management/training

To apply for a position send your resume to Jobs@JGBBioPharma.com

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78) Scientist – Contract (San Francisco Bay Area) 5671J73

DESCRIPTION:

  • Run chef instruments
  • Generate samples for sequencing instruments
  • Analyze data using excel or JMP software
  • Some scripting work
  • Guava analysis
  • Run manual sample prep
  • Run sequencing machines

EXPERIENCE AND QUALIFICATIONS:

  • Experience in system engineering or medical device development
  • Development experience on complex systems within the biotechnology sector– Next Gen sequencing experience is a plus
  • Experience with cell culture, Immunohistochemistry, and particle analysis instruments
  • DNA sequencing
  • Understanding of Bioinformatics
  • Understanding of programming
  • Extremely motivated and be willing to work in a fast-paced environment, hard-working and multidisciplinary team;
  • Resourceful and flexible
  • Adept at planning, prioritizing, multi-tasking, organizing and following through, while remaining highly energetic and focused
  • Straightforward, self-motivated, and trustworthy
  • Energetic and willing to work hands-on in developing and executing a variety of activities
  • An individual with experience in biotechnology or medical device development;
  • An individual with some hands-on experience with current molecular biology techniques and DNA sequencing would be highly regarded in consideration for this position.
  • B.S. or M.S. in Bioengineering or Molecular Biology or related field.
  • Experience with a variety of laboratory devices and instrumentation, including PCR and flow cytometry
  • Strong organizational, communication and team skills, and thrive in a fast-paced environment
  • Proficient at Excel, Word, and PowerPoint
  • Understanding of Genetics

To apply for a position send your resume to Jobs@JGBBioPharma.com

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79) CMC Project Manager – Contract (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) YP131G

DESCRIPTION:

  • Facilitate cross-site collaboration for early and/or late stage development activities. 
  • Responsible for collaboration with team members to track tasks and maximize resources through the application of project management best practices
  • Facilitates information flow between team members and functional leaders.
  • Collaborate with program and team leaders for development of standardized project plan templates.
  • Focus on key tasks, critical milestones and decision points supporting the organization’s portfolio management. 
  • Conduct planning sessions to develop new project plans for upcoming projects. 
  • Ensure suitable composition of departmental teams to support the projects in cooperation with line function management.
  • Support teams with quality awareness, critical thinking, management capabilities and scientific and technical expertise. Win commitment and resolve team and program issues/conflicts through the application of project management best practices to ensure program objectives are meant.
  • Essential to work in a highly integrated manner with the technical lead and program manager
  • Ensure alignment with other departments and functions with focus on clear communication of requirements.
  • Responsible for meeting agenda and minutes.
  • Assess, consolidate and negotiate within department and with management resource needs and constraints, and timelines for assigned projects on an on-going basis
  • Support the program budget planning process through work plan preparation, risk management and maintenance.
  • Understand and proactively manage interactions of project related activities between own department and other departments 
  • Ensure timely availability of agreed deliverables.
  • Meeting agreed program timelines and deliverables.
  • Clear demonstration of effective verbal and written communication.
  • Effective interaction with cross functional peers to facilitate completion of deliverables.
  • Effective interaction of program budget including external expense and FTE requirements
  • Effective communication to management on resource needs, program risks and assumptions and possible delays.

EXPERIENCE AND QUALIFICATIONS:

  • A minimum of a Bachelor’s degree in a scientific discipline is required.
  • Certification in Project Management is preferred.
  • A minimum of 5 years project management experience in the Pharmaceutical, Medical Products or other related industry is desired.
  • Prior experience in managing interdisciplinary or cross functional teams is required.
  • Understanding of FDA regulatory processes and prior experience with regulatory filings is highly desired.
  • A working knowledge of basic financial accounting is required.
  • Strong working knowledge of MS Word, Excel, and PowerPoint and Project is required.
  • Must be able to demonstrate analytical and problem solving capabilities.
  • Excellent oral and written communication skills are required
  • Must be able to demonstrate strong organizational skills.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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80) Contract Tier Representative – Contract (New Jersey) 7717

DESCRIPTION:

  • Handles routine customer service inquires related to human resources, payroll and benefits administration and provides Q&A support as needed. 
  • Opens tickets and logs calls into a computerized call tracking system  
  • Answers questions by primarily relying on standard screens, scripts and procedures for call resolution. 
  • Works closely with the other components of the HR function to escalate cases and sufficiently address customer needs.
  • Answers general questions and redirects misplaced calls.
  • Uses procedures, policies, knowledge database and other reference materials to assist in answering employee, manager and agency HR, payroll or benefits representative inquires.
  • Guides employees and managers on using the on-line tool.
  • Receives and processes employee data change requests or appropriately escalates issues.
  • Collects and validates complete data required to process manual employee personal and organizational transactions and escalates the completed data to the center for processing.
  • Escalates complex issues/inquires to other parts of HR or redirects calls to ITS or other appropriate groups.
  • Provides support and coaching to peers
  • Participates in continuous improvement workshops and project

EXPERIENCE AND QUALIFICATIONS:

  • 1 or more years of general HR experience.
  • Ability to follow strict policy guidelines.
  • Ability to navigate computerized data entry system and other relevant applications.
  • Ability to recognize situations requiring call escalation.
  • Ability to follow standard procedures and scripts without variation.
  • HRIS experience preferred.
  • Strong oral communication skills.
  • Strong listening skills.
  • Strong customer service focus.
  • High School Degree or equivalent work experience.


To apply for a position send your resume to Jobs@JGBBioPharma.com

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81) Executive Director, Development Sciences, Operations Management – Full Time (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) PT113F

DESCRIPTION:

  • Collaborate closely with the team and cross-functional key stakeholders to conduct studies on time, with quality and within budget. 
  • Provide strategic leadership and oversight in the development and implementation of new processes or systems to advance the growth and effectiveness of the functions.
  • This position will report to the VP of Development Sciences Operations Management.  
  • Candidates for this position must have a strong foundation in clinical development/clinical operations and a track record of building successful collaborations including models involving investigator or group-sponsored trials with pharma/biotech involvement.
  • Partner with the development sciences and corporate development leadership, the clinical lead, and other corporate functions as needed to ensure successful implementation and management of the project
  • Develop command of the project and program deliverables
  • Form an internal working group for the project composed of functional subject-matter experts and work with this group to present a united voice and perspective on key issues
  • Ensure effective operational execution of the studies and management of the program
  • Develop and oversee a study implementation plan that includes a detailed task ownership matrix and description of tasks and key program milestones
  • Create and track study quality metrics to ensure accurate and high quality data collection and protocol adherence around key data variables
  • Communicate risks and mitigation strategies relating to scope, schedule, resources and quality to senior leadership
  • Develop positive and strong working relationships; model effective collaboration
  • Available on site for frequent in-person interactions
  • Pursue timely and pro-active issue resolution
  • Partner with vice president to provide strategic leadership in addressing initiatives and issues to ensure operational consistency and successful trial execution across multiple programs

EXPERIENCE AND QUALIFICATIONS:

  • Requires Bachelor degree or equivalent combination of relevant educational and professional experience.  
  • Strong scientific, technical or business background desired.
  • 15 years of Pharma/Biotech experience including at least 10 years of clinical development management experience  
  • Track record of building effective collaborations including models involving investigator or group-sponsored trials with pharma/biotech involvement
  • Extensive knowledge of overall drug development process, and in particular clinical operations, and roles for the various functional areas within research and development
  • Extensive knowledge of Good Clinical Practices and application to the conduct of clinical studies
  • Strong leadership skills; ability to make and lead decisions when necessary
  • Strong financial acumen; capable of planning and oversight of project budgets
  • Proven personnel management, communication, interpersonal and influence skills
  • Ability to gain cooperation of others through consensus building
  • Excellent written and verbal communication skills
  • Keen listening skills
  • Ability to influence the thinking of or gain acceptance of others in sensitive situations
  • Excellent presentation skills with ability to present program information of a multi-disciplinary and complex nature
  • Strong strategic and analytical problem solving skills that leads to positive and productive relationship outcomes

To apply for a position send your resume to Jobs@JGBBioPharma.com

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82) Admin Assistant IV (Executive) – Contract (New Jersey) 6829

DESCRIPTION:

  • Assist in the administration of the NA Compliance Department, including setting up domestic and international travel, expense tracking, contracts and project tracking, coordinating and setting up internal and external meeting, ensuing a smooth and efficient flow of day-to-day operations.
  • Complex calendar and meeting planning, including management of logistics for teleconferences, videoconferences, web-based meetings
  • Interface with staff and senior level managers, internal/external customers and vendors. 
  • Must be highly proficient at Microsoft office applications, including PowerPoint presentations and graphics.
  • Must have a proactive style and be able to work I'm a fast paced and complex business environment.
  • Assist in the structure of agendas, meeting minutes and follow-up of action items
  • Manage logistics for compliance committee meetings, including sr. management/leadership
  • Assist in preparation of reports and presentations.
  • Available to be of assistance as miscellaneous projects/situations arise within the department.
  • Ability to work independently and manage specialized projects as appropriate.
  • Manages multiple, sometimes conflicting, priorities in a fast-paced and demanding environment.
  • Prioritizes and executes tasks with minimal direction or supervision. Compiles and prepares information for presentations using MS Office software. 
  • Assist other members of department on specialized projects as appropriate
  • Central point of contact and coordination of activities for AVP, and the team.
  • Extensive maintenance of managers' daily calendar and coordinate materials needed for daily activities. 
  • Provide general administrative duties such as filing, faxing, photocopying, preparing correspondence, preparing expense reports, and maintaining calendars for department.  

EXPERIENCE AND QUALIFICATIONS:

  • Ability to organize and prioritize, work independently and meet deadlines.
  • Strong organizational/communication skills (both verbal and written) required.
  • Excellent telephone skills.
  • Ability to use the internet to locate pertinent information when required.
  • Experience in interacting with all levels of management and with global colleagues.
  • Excellent PC skills (especially with MS Office products and web browsers).
  • Ability to prepare documents, presentations, and excel budget tables with minimal instruction.
  • Demonstrate proficiency in e-mail, power point, MS Office suite, Outlook calendar and browser usage.
  • Ability to handle confidential matters and information with discretion and diplomacy.
  • Ability to work in a fast paced, rapidly changing environment.
  • Detail-oriented and able to handle multiple tasks simultaneously
  • Associates Degree or equivalent required. Bachelor’s degree is a plus.
  • Experience in administrative support at senior management level preferred.
  • Prior experience in pharmaceutical industry preferred.
  • Legal or Compliance experience within the pharmaceutical industry is desirable.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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83) Publication Planning Lead (Associate Director Medical Communications) – Full Time (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) A132FJ

DESCRIPTION:

  • Responsible for developing scientifically accurate publications and presentations.  
  • Assist with preparation of peer-reviewed journal articles; and congress abstracts, posters, and presentations for sponsored clinical trials
  • Work with internal stakeholders, external authors and medical writers on oral presentations, posters, abstracts, and manuscripts
  • Coordinate internal, partner and external reviews of publication materials
  • Adjudicate reviewer comments with internal and external authors
  • Attend medical and scientific conferences to support sponsored speakers and presentations.
  • Proactively review and interpret pertinent and emerging scientific literature
  • Evaluate clinical trial data from TFLs
  • Ensure publications convey accurate and non-misleading messages or impressions of the product
  • Ensure developed publications are reviewed and approved according to SOP
  • Supervise the work of vendors for medical writing, ensuring work is high quality and developed on time and within budget

EXPERIENCE AND QUALIFICATIONS:

  • Experience in publications and medical writing
  • Excellent communication, organizational, negotiation and time management skills with individuals and groups
  • Ability to work across multi-disciplinary groups and within a matrix environment
  • Experience in hematology/oncology area preferred
  • Ability to summarize complex information and present in a clear, concise, and scientifically accurate manner to a range of audiences
  • Knowledge of good publication practices and guidelines (GPP2, ICMJE)
  • Experience in preparing abstracts, posters, presentations and manuscript
  • Strong problem solving, decision-making, influencing, and negotiation skills
  • Effectively build relationships and work with global medical thought leaders
  • Think strategically; apply knowledge and analytical skills in a highly regulated environment.  
  • 5+ years of experience in industry (e.g., biotech/pharmaceutical/medical device company, contract research organization), academic research, or public health
  • Advanced degree (PhD preferred) in science-related field with 5+ years of experience in biotechnology or pharmaceutical industry; Hematology/Oncology experience preferred                                                                                                                   

To apply for a position send your resume to Jobs@JGBBioPharma.com

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84) Copywriter – Contract (Southern California) 73Z0909

DESCRIPTION:

  • Searching for a strong copywriter/copy editor with an eagle eye for detail, a good sense of humor, and a will-do attitude. 
  • The team supports a large internal client base with needs ranging from ads to emails, brochures to flyers, billboards to web banners.
  • Will handle both overflow copywriting/copy editing for a high volume of these types of pieces under short timelines, as well as creative concepting. 
  • It requires a person who can write quickly and well, isn’t afraid to distill at-times challenging scientific subject matter into compelling marketing copy, and can come up with clever headlines and messaging, as well as long-form editorial content.

EXPERIENCE AND QUALIFICATIONS:

  • Strong copywriting/copy editing background and ability to deliver concise content that adheres to our brand style guidelines; ensures correct trademark usage, grammar, punctuation, etc.; and upholds a consistent approach across all marketing materials
  • Ability to distill complex technical/scientific information into effective value-driven messaging
  • Expert knowledge of Chicago style
  • Preference for and ability to thrive in a fast-paced, dynamic environment
  • Excellent collaboration and customer service skills
  • Understanding of marketing best practices
  • Exceptional attention to detail and high regard for quality
  • Creative advertising agency experience a plus
  • Science background a plus (esp. biology or chemistry), but not necessary
  • BS in English, journalism, marketing, advertising, or related field and 3–5 years of copywriting/copy editing experience 

To apply for a position send your resume to Jobs@JGBBioPharma.com

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85) Clinical Trial Manager for Investigator Sponsored Trials – Contract (New Jersey) 8426

DESCRIPTION:

  • Act as the Clinical Trial Manager in the implementation of investigator sponsored trials primarily in Oncology, may include other therapeutic areas. 
  • Coordination of concept submissions to cross-functional committee teams review and forecast and tracking of study budgets and milestones
  • Provide periodic updates to the cross-functional team members. 
  • Lead the clinical trial team overseeing all trial activities ensuring timelines are met and budget is managed appropriately

EXPERIENCE AND QUALIFICATIONS:

  • Strong budget management experience
  • The ability to work both independently and collaboratively on project team
  • Working knowledge of GCP and local regulatory requirements is desired.
  • Minimum of a BSN, BA or BS in a scientific discipline and at least 4 years of clinical research experience, 2 in Oncology.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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86) Executive Associate – Contract (New Jersey) 6170

DESCRIPTION:

  • Assist in the administration of the department, including setting up an accurate filing system, expense tracking system, contracts and project tracking, departmental meetings
  • Interfaces with staff and senior level managers, internal/external customers and vendors. Ensures a smooth and efficient flow of day-to-day operations.
  • Complex meeting planning, including management of logistics for teleconferences, videoconferences, web-based meetings
  • Assist in the structure of calendar agenda and follow-up of action items
  • Manage logistics for strategic and operating plan review meetings, and business reviews
  • Pro-actively manages the calendar, schedules meetings, manages domestic and global meeting logistics and arranges domestic and international travel with both internal and external parties for manager and team members as requested.
  • Assist in preparation of reports and presentations.
  • Available to be of assistance as miscellaneous projects/situations arise.
  • Ability to work independently and manage specialized projects as appropriate.
  • Manages multiple, sometimes conflicting, priorities in a fast-paced and demanding environment.
  • Prioritizes and executes tasks with minimal direction or supervision. 
  • Compiles and prepares information for presentations using MS Office software. 

EXPERIENCE AND QUALIFICATIONS:

  • Ability to organize and prioritize, work independently and meet deadlines.
  • Strong organizational/communication skills (both verbal and written) required.
  • Excellent telephone skills.
  • Ability to use the internet to locate pertinent information when required.
  • Experience in interacting with all levels of management and with global colleagues.
  • Excellent PC skills (especially with MS Office products and web browsers).
  • Ability to prepare documents, presentations, and excel budget tables with minimal instruction.
  • Demonstrate proficiency in e-mail, MS Office suite, Outlook calendar and browser usage.
  • Ability to handle confidential matters and information with discretion and diplomacy.
  • Ability to work in a fast paced, rapidly changing environment.
  • Detail-oriented and able to handle multiple tasks simultaneously
  • Expertise in PowerPoint
  • Scheduling-both travel and meetings
  • Corporate experience should be mandatory
  • Communication skills incredibly important given global nature of the business and representation of the organization
  • At minimum ten year’s experience in administrative support at senior management level 
  • Prior experience in pharmaceutical industry preferred
  • Financial reporting experience with the pharmaceutical industry is desirable
  • Associates Degree or equivalent required. Bachelor’s degree is a plus.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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87) (Senior) Bioinformatics Scientist – Full Time (New York) GP143V

DESCRIPTION:

  • Working with standard bioinformatics tools and visualization packages
  • Automating and refining the processing and analysis of large data sets
  • Developing and using bioinformatics pipelines to prepare and analyze data
  • Designing, developing, and maintaining databases for scientific and commercial applications
  • Analyzing and working with NGS data, ideally whole genome sequence data


EXPERIENCE AND QUALIFICATIONS:

  • PhD in Bioinformatics, Computational Biology, Computer Science, Mathematics, Statistics, Genetics, Biology or related Genetics field with additional postdoctoral or industry experience (for Senior role)    
  • Proficiency in Python, Perl, Java, C/C++, and R programming
  • Good working knowledge of current best practices in genetic variant discovery, variant analysis, and validation methods
  • Experience with Whole Genome sequence data required (e.g. not microbes, plants etc.)
  • Strong organizational, written, and communication skills
  • Good analytical and problem solving abilities
  • A proven publication record
  • Experience in human genetics is highly preferred
  • Enjoys working in highly collaborative environment with diverse team to tackle complex problems
  • Is disciplined and driven to deliver ongoing research results
  • Has a positive attitude with willingness to be hands on when needed
  • Highly organized
  • strong written and verbal communicator
  • Has hard work ethic with emphasis on execution

To apply for a position send your resume to Jobs@JGBBioPharma.com

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88) Associate Scientist II - R&D – Contract (San Francisco Bay Area) 73B6551

DESCRIPTION:

  • Responsible for creating and developing ideas into successful products. 
  • Requires scientists who are proficient in wet lab bench work to perform experiments for PCR reagents product development. 
  • The successful candidate will have flexible and adaptable mindset and able to work on several real time PCR systems. 
  • The junior candidate will be guided by directive of an established project or a senior member of the group. 
  • Require ability to solve problem independently. 
  • Needs to understand the scientific method and work in a collaborative and fast paced product development group. 
  • Work with a team of scientists to develop and optimize reagents for application
  • Validate new PCR reagents on various real time PCR systems
  • Conduct biochemistry and molecular biology experiments, data analysis and result presentation.

EXPERIENCE AND QUALIFICATIONS:

  • 1-3 years of industrial experience
  • Strong working knowledge of nucleic acid amplification-based methods, statistical methods for experimental design and data analysis
  • Excellent written and oral communication skills, and computer skills. Understanding of DNA sequence and basic level of bioinformatics is required. 
  • Extensive knowledge of DNA polymerases and reverse transcriptase.
  • Self-motivated and able to ensure focused and timely execution of projects
  • Technical level of self guided troubleshooting ability especially in the PCR/qPCR subject area.
  • Excellent written and oral communication skills, and computer skills. Understanding of DNA sequence and basic level of bioinformatics is required.
  • Strong desire to work in an interdisciplinary team environment
  • MS or BS degree in biological sciences.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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89) Project Management – Contract (San Francisco Bay Area) 6614K73

DESCRIPTION:

  • To manage the product commercialization process/new product development and introduction through the stage gate process, managing scope, schedule, risks, issues, trade-offs, communications, and expectations.  
  • To represent the organization in assuring the teams follow product development best practices, and in some cases adhere to specific regulatory requirements, as they lead project teams through the product commercialization process (PCP). This includes assuring design control and thereby long-term product supportability, as well as delivering the agreed upon business value.
  • To demonstrate and adhere to project management best practices, with the goal of not only delivering a product of high quality and value to the organization, but delivering within the agreed upon project contract metrics of schedule, resources, budget and scope.
  • Lead, manage, coordinate, synchronize, and be accountable for the execution of programs from Product Concept through Product Launch & Program Closure.
  • Act as information conduit between the Core Team and Sr. Management; prepare and present Phase Reviews to the Product Approval Committee (PAC) as Core Team representative; initiates Exception Reviews as necessary.
  • Act as project champion and project “general manager”; manages team to execute all project deliverables; leads cross-functional core team.
  • Lead teams to define and prioritize scope, objectives, and requirements.
  • Plan resource requirements and negotiate Core Team resources with functional managers; assist Core Team Members in negotiating extended team staffing.
  • Develop accurate, actionable, and cross-functionally integrated program plans based on business goals, constraints, and risk tolerance.
  • Develop and assertively drive timelines and budgets in coordination with other departments and teams.
  • Drives risk assessment, communication, proactive mitigation planning, and contingency response planning.
  • Regularly track and communicate project status to all stakeholders; schedule and drive core team meetings.
  • Assist Core Team Members in resolving extended team and functional issues.
  • Collaborate and coordinate across all the functional areas (R&D, Marketing, Product Management, QA/QC, Regulatory, Legal, Operations, Manufacturing, Service and Support and others) necessary to insure successful program completion and product launch.
  • Contribute to performance evaluation of Core Team Members
  • Develop and deliver original persuasive presentations
  • Guide program teams through and execute Voice of the Customer (VOC) and User Centered Innovation (UCI) processes in partnership with Product Management and R&D.
  • Build effective relationships with core and extended team members, functional managers, senior management, and customers.
  • Track and monitor team progress against requirements and plans; resolve deviations.
  • Lead, document, and communicate constructive lessons-learned analysis of completed programs.

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor’s degree (B.S./B.A.) minimum, preferably in a scientific/technical discipline (e.g. biology, chemistry, engineering). 
  • Minimum of 4 years of experience combined between product/program management and product development, preferably in the life sciences/biotechnology. 
  • Stage-gate product development process experience.
  • VOC process experience preferred.
  • PMP certification preferred.
  • Ability to distill, prioritize, and act on feedback from a variety of sources.
  • Ability to do the right thing under pressure and tight deadlines in a complex, matrixed environment.
  • Ability to work independently without significant direction
  • Excellent critical thinking, troubleshooting, crisis management, and decision-making skills.
  • Excellent interpersonal and relationship building skills, and the ability to work effectively with a variety of other personal styles. 
  • Excellent leadership skills particularly the ability to influence stakeholders in other functions over whom the Program Manager has no direct managing authority.
  • Excellent oral and written communication skills.
  • Initiative. Self-motivated and independent thinker that routinely translates circumstances and understanding into actions that move the business forward in a measurable manner.
  • Meticulous attention to detail and a passion for driving execution at a detail level when necessary while maintaining the ability to see the big picture.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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90) HTML / Web Content Producer – Contract (Southern California) 73J2298

DESCRIPTION:

  • Seeking an experienced HTML or Web Content Producer capable of designing web pages within Adobe CQ5. 
  • Will be designing pages, creating enhancements and customizations to existing pages using CQ 5. 
  • The individual will address time sensitive content needs responding expediently to enhance overall user experience. 
  • Will work closely with the Web Operations Manager, Traffic Manager and Web Producers.  
  • The ideal candidate has a minimum of 4 years of hands-on professional experience of Web Design.

EXPERIENCE AND QUALIFICATIONS:

  • 4+ years of experience with Web Design and Content Management  within Adobe CQ
  • 4+ years of experience with HTML 
  • 2-4+ years of experience designing web pages within Adobe CQ5 
  • Proficient in Adobe Photoshop
  • A strong eye for layout design
  • Demonstrated ability to enhance, customize and design web pages and content
  • Excellent organizational, verbal and written communication skills
  • Experience using robust project management tool, such as MARS, Basecamp, JIRA, Open Office, etc.
  • Experience in working with in a fast-paced, collaborative, and team-based project environment
  • Javascript, CSS experience, Agile/Scrum environment and enterprise content management experience within an eCommerce environment skills ideal, but no required

To apply for a position send your resume to Jobs@JGBBioPharma.com

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91) Associate Director/ Director CMC – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) GT113F

DESCRIPTION:

  • Proactively managing CMC aspects of one or more global commercial programs including overseeing preparation and submission of global CMC submissions, including marketing and clinical trial applications. 
  • Ensuring that CMC content is complete, well-written, and meets all relevant requirements. 
  • Evaluating proposed manufacturing changes for global impact to ongoing and existing filings, and provides strategic regulatory guidance for optimal implementation of changes. 
  • Researching and interpreting global CMC regulations and, providing regulatory guidance to the Quality, Manufacturing, Process Development and other functional groups.
  • Representing the Regulatory Affairs CMC function on assigned cross-functional project teams.
  • Managing interactions with FDA and other global regulatory authorities for assigned project to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which present CMC information. 
  • Developing excellent relationships with internal functional groups, contract manufacturing organizations, and corporate partners.

EXPERIENCE AND QUALIFICATIONS:

  • 6-8 years of experience in Regulatory Affairs in a global pharmaceutical and/or biotechnology company with expertise in biologics and deep experience in commercial product lifecycle as well as Phase 1-3.  Experience with commercial small molecules may also be considered.
  • At least 2 years of previous supervisory experience managing associates is required.
  • Thorough understanding of relevant drug development regulations and guidelines is essential.
  • Prior success filing marketing applications, supplements, and variations for biologic products within timelines is required; global submission experience desired.
  • Experience in assessing post-approval changes is required.
  • Demonstrated ability to coach, train and mentor teams.
  • Outstanding interpersonal and communication (written and verbal) skills is required
  • Strong writing and editing skills for technical documentation.
  • Proficient with computer and standard software programs.
  • Able to travel 10%.
  • BA/BS degree in life sciences in chemistry, molecular biology, or similar is desirable.  
  • Advanced degree is a plus.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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92) Project Manager – Contract 9-12 Months (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) P131JF

DESCRIPTION:

  • Project manages approximately 1-2 projects.  
  • Facilitate cross-site collaboration for early and/or late stage development activities. 
  • Responsible for collaboration with team members to track tasks and maximize resources through the application of project management best practices. 
  • Facilitates information flow between team members and functional leaders.
  • Collaborate with program and team leaders for development of standardized project plan templates. Focus on key tasks, critical milestones and decision points supporting the organization’s portfolio management. 
  • Conduct planning sessions to develop new project plans for upcoming projects.  
  • Ensure suitable composition of departmental teams to support the projects in cooperation with line function management.  
  • Support teams with quality awareness, critical thinking, management capabilities and scientific and technical expertise.  Win commitment and resolve team and program issues/conflicts through the application of project management best practices to ensure program objectives are met. 
  • Essential to work in a highly integrated manner with the technical lead and program manager.
  • Ensure alignment with other departments and functions inside with focus on clear communication of requirements.  
  • Responsible for meeting agenda and minutes.
  • Assess, consolidate and negotiate within department and with management resource needs and constraints, and timelines for assigned projects on an on-going basis. 
  • Support the program budget planning process through work plan preparation, risk management and maintenance. 
  • Understand and proactively manage interactions of project related activities between own department and other departments
  • Ensure timely availability of agreed deliverables. 
  • Meeting agreed program timelines and deliverables.
  • Clear demonstration of effective verbal and written communication.
  • Effective interaction with cross functional peers to facilitate completion of deliverables.
  • Effective interaction of program budget including external expense and FTE requirements.
  • Effective communication to management on resource needs, program risks and assumptions and possible delays.

EXPERIENCE AND QUALIFICATIONS:

  • A minimum of a Bachelor’s degree in a scientific discipline is required.
  • Certification in Project Management is preferred.
  • A minimum of 5 years project management experience in the Pharmaceutical, Medical Products or other related industry is desired. 
  • Prior experience in managing interdisciplinary or cross functional teams is required.
  • Inhalation product development experience is desired.
  • Understanding of FDA regulatory processes and prior experience with regulatory filings is highly desired.
  • A working knowledge of basic financial accounting is required.
  • ·Strong working knowledge of MS Word, Excel, and PowerPoint and Project is required.
  • Must be able to demonstrate analytical and problem solving capabilities.
  • Excellent oral and written communication skills are required
  • Must be able to demonstrate strong organizational skills.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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93) Chemical Engineer Manager – Full Time (Oregon) RZ41M

DESCRIPTION:

  • Successful candidates will have strong understanding of fundamental theories and be able to apply them in an experimental setting.   
  • This is a team leadership position.
  • Seeking a team leader and manager with a strong technical background.  

EXPERIENCE AND QUALIFICATIONS:

  • Experience in one or more of these areas of expertise is preferred: mathematical (steady state and dynamic) modeling, experimental design, and the analysis and clear presentation of experimental results.  
  • Experience with control system design (MPC, optimization, automation hardware/software); computational fluid dynamics (CFD) modeling software packages (e.g., FLUENT, Gambit); materials science; and latent variable modeling , as is experience in an experimental lab environment. 
  • Strong communication skills are required due to the strong teamwork orientation of the company, the multidisciplinary nature of the work, and the customer interaction that is required. 
  • Successful candidates must be able to learn quickly and work independently in a fast-paced environment. 
  • A sense of humor is essential.
  • B.S., M.S. or Ph.D Chemical Engineering
  • A minimum of 8 years experience as a Chemical Engineer in a Team Leader and / or Management role.
  • Pharmaceutical Industry experience is preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

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94) IT Site Manager – Full Time (Oregon) G41JY

DESCRIPTION:

  • Provide leadership and guidance to the local business by managing the IT infrastructure, operations, budget and staff for the assigned location/business unit.  This position drives the identification, implementation and maintenance of new technologies/business applications through the application of current corporate best practices and ensures that IT operations meet the needs of the business. 
  • Reports to the Regional IT Director.
  • Evaluates and makes recommendations regarding systems and facility requirements to ensure that the IT infrastructure supports and facilitates the growth of our manufacturing operations and expanding business needs
  • Oversees the planning, design, installation and maintenance of systems, networks, security systems, telecommunication systems, servers, mainframes and other IT resources or assets
  • Acts as the IT liaison for the assigned site and corporate leadership teams
  • Provides technical consulting and problem resolution at the leadership level
  • Budgets for site expenses and capital purchases of technology-related equipment & services
  • Identifies and recommends opportunities for cost-savings and process improvements
  • Monitors and reports on the performance of IT systems, projects and operations
  • Manages site specific vendor contracts and relationships, ensuring established SLAs are being met
  • Manages the implementation and support of all systems and business applications for the assigned site to include: manufacturing, operations, sales, and administrative areas
  • Implements standard operating procedures and ensures that daily IT operations are functioning in the most efficient and effective manner
  • Provides direction, coordination, and evaluation of subordinate staff

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor’s degree in IT, IS, Engineering or related field and 7+ years’ experience in progressive IT leadership roles, managing IT operations, infrastructure and projects
  • Strong Business process skills in terms of evaluating what systems are needed, and how to select the s/w for these systems.
  • Prior experience implementing SAP financials, sales, distribution and material management modules
  • Previous IT experience in a Commercial Pharmaceutical Manufacturing facility Required
  • Excellent change and project management skills
  • Strong leadership skills and the ability to effectively interact with colleagues at all organizational levels

To apply for a position send your resume to Jobs@JGBBioPharma.com

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95) Project Manager I/II, Pharmacological Sciences Operations – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) Z113FP

DESCRIPTION:


Candidate project manages drug development programs for the Pharmacological Sciences (PharmSci) organization that range from IND-enabling through post approval phases. This individual will partner with the PharmSci Subteam Lead (PSTL) in leading the PharmSci Subteam (PST) to identify and manage project-related priorities, apply standard and novel project management tools, processes and principles for the PharmSci Subteam in order to meet the established overall program goals and objectives. This individual will develop strategies for monitoring progress and for intervention/problem-solving in collaboration with the Pharmacological Sciences Subteam Leader, Functional Area Leads and other internal and external stakeholders, as appropriate.  The Project Manager interacts with individuals within PharmSci as well as across multiple functional areas, including Development Sciences Project Management, GxP Compliance, Clinical, BioMetrics, Regulatory Affairs, Regulatory Operations, Research & Drug Discovery, and Product Development to ensure corporate goals are met. This individual may represent PharmSci on clinical project teams and sub-project teams.

Responsibilities:
  • Responsible for project managing two or more programs in clinical development phase for the Pharmacological Sciences (PharmSci) organization.
  • Partners with the Pharmacological Sciences Subteam Leader (PSTL) to facilitate the Pharmacological Sciences Subteam (PST) meetings, including but not limited to, meeting organization, meeting minutes and follow up on cross-functional actionable items.
  • Works with PST leads team members, which includes Pharmacokinetics/Pharmacodynamics, Pharmacology and Toxicology, Immunogenicity Assessment, BioAnalytical Sciences and Nonclinical Study Management to develop and maintain overall PharmSci specific timelines to align activities with Core Team milestones and objectives.  Utilizes strong influence management skills to coordinate cross functional efforts and meet overall team objectives.
  • Develops detailed project schedules that integrate key activities, timelines and resources, and tracks the critical path for assigned projects.
  • Develops, independently and as part of a team, decision-making methodologies, tools and solutions for the PharmSci Subteam to identify complex issues with cross functional mid- to long-term project- and program-level impact.
  • Facilitates risk management discussions within the PharmSci Subteam and develops risk mitigation plans with key stakeholders, as necessary.
  • Performs duties under some supervision for complex tasks and problems and independently in all other tasks

EXPERIENCE AND QUALIFICATIONS:

  • 4-8 years of work experience in a pharmaceutical, biotechnology or contract research organization or equivalent with a minimum of 2-4 years of direct project management experience.
  • Excellent verbal and written communication skills.
  • Excellent organizational skills and the ability to manage multiple projects and multiple tasks simultaneously in a fast paced environment.
  • Skilled at developing and maintaining professional interpersonal relationships with colleagues in order to complete the given tasks.
  • Bachelor’s (BS/BA) in Biological Sciences or closely related field of study
  • Preferred experience in the overall drug development  process including the development of large molecules.
  • Preferred experience with regulatory submissions and associated requirements
  • Preferred experience with using MS Project to develop and maintain project timelines.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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96) Clinical Supply Manager – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) GC117R

DESCRIPTION:


Responsible for planning, packaging, labeling and distribution of investigational medicinal product (IMP) and any additional study medication/products to support global clinical trials. Main responsibilities include oversight and management of multiple Contract Manufacturing Organizations (CMO’s) and distribution providers.  Ensure operations and activities are executed in accordance with all internal SOPs, procedures and policies and in accordance with all county, state, and federal regulations including cGMP & ICH.

Responsibilities:
  • Manage the storage, distribution and inventory tracking of bulk product, labeled product, co-medication inventory and materials throughout the supply chain at CMO’s in the most cost effective manner and in compliance with cGMP’s.
  • Manage the day-to-day fulfillment of drug shipment requests for all products under clinical development in a cost effective and cGMP compliant manner. Manage multiple vendor relationships, supply chain, distributions and return/destruction operations using IXRS supply and distribution modules.
  • Collaborate to develop strategic plans with Regulatory Affairs, Quality and Clinical Operations colleagues to ensure adequate drug supply, considering expiry dating and patient activity for all sites in a global program.
  • Schedule and implement labeling, packaging and quality release operations with the CMO and multi-disciplinary team to ensure continuous clinical supply.
  • Responsible to receive reports on excursions or deviations which may occur during shipment, handling, and storage of drug products. Drive such investigations to resolution in collaboration with Quality, CMO and clinical sites and define and implement procedures to minimize future such occurrences.  Collaborate with QC/QA to define acceptable practices and procedures for handling excursions or deviations from recommended storage and handling conditions based upon review of available stability data.
  • Develop tracking systems to document the genealogy and detailed lot usage history of all drugs for each clinical trial.
  • Working with CMOs, manage the distribution and global depot locations with special considerations on import licenses and shipping lead times for country specific requirements.  
  • Arrange for cost effective return/destruction of all product no longer suitable for clinical use.
  • Meet financial objectives of by forecasting budget requirements; preparing project budget; reviewing CMO proposals, issuing and scheduling expenditures; analyzing change in scope and reviewing Invoices for accuracy.  
  • Responsible for building and maintaining an effective business partnership among internal departments such as Finance and Clinical Operations Departments.
  • Active participation in a variety of team meetings and or committees will be required.
  • Must be willing to travel at least 25%-35% of the time, as measured on a calendar quarter (there may be quarters where travel will be 0%).  Both domestic and international travel may be required.

EXPERIENCE AND QUALIFICATIONS:

  • Project Management skills in multidisciplinary environment with complex strategies and geographical specific requirements and ability to adapt to changes. 
  • Excellent organization skills, ability to lead multidisciplinary teams with excellent oral and written communication skills.   
  • Experienced and successful at developing project budgets, tracking budget expenses, contract negotiation, and various financial operations.  
  • Able to analyze and resolve complex logistical issues in a scientific and heavily regulated GMP environment, considering multiple factors and timelines.  
  • Strong analytical and organizational skills. 
  • Ability to work in a fast-paced environment with competing priorities and frequent tight deadlines is essential.
  • Ability to work on assignments that are complex in nature where judgment is required in solving problems and making routine recommendations. 
  • Demonstrated ability to lead clinical budgeting/forecasting process, summarize results and effective communication of results are required.
  • Attention to detail combined with a high degree of accuracy.
  • Ability to use Excel and Microsoft Word software applications for business correspondence, record-keeping and employee benefits information, meetings, documents and presentations. 
  • Excellent desktop software skills including Excel, Outlook and PowerPoint.
  • Ability to work on assignments that are complex in nature where judgment is required in solving problems and making routine recommendations.
  • Candidate must have a Bachelor of Science degree with one of the following additional degrees preferred; MS or PharmD degree in scientific discipline.
  • Minimum of five  years’ experience working in a Manufacturing or Pharmaceutical Environment, at least two to three years of which directly involve Clinical Supplies/Supply Chain, Clinical Operations, Quality, or CMC role in a Biotech, Pharmaceutical, or CRO company.
  • Significant experience managing and influencing customer demands.
  • Working knowledge of the Clinical Trial Directive and global regulatory environment impacting the provision of investigational products in depth knowledge of R&D supply chain and drug development process.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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97) Clinical Supply Manager – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) GC117R

DESCRIPTION:


Responsible for planning, packaging, labeling and distribution of investigational medicinal product (IMP) and any additional study medication/products to support global clinical trials. Main responsibilities include oversight and management of multiple Contract Manufacturing Organizations (CMO’s) and distribution providers.  Ensure operations and activities are executed in accordance with all internal SOPs, procedures and policies and in accordance with all county, state, and federal regulations including cGMP & ICH.

Responsibilities:
  • Manage the storage, distribution and inventory tracking of bulk product, labeled product, co-medication inventory and materials throughout the supply chain at CMO’s in the most cost effective manner and in compliance with cGMP’s.
  • Manage the day-to-day fulfillment of drug shipment requests for all products under clinical development in a cost effective and cGMP compliant manner. Manage multiple vendor relationships, supply chain, distributions and return/destruction operations using IXRS supply and distribution modules.
  • Collaborate to develop strategic plans with Regulatory Affairs, Quality and Clinical Operations colleagues to ensure adequate drug supply, considering expiry dating and patient activity for all sites in a global program.
  • Schedule and implement labeling, packaging and quality release operations with the CMO and multi-disciplinary team to ensure continuous clinical supply.
  • Responsible to receive reports on excursions or deviations which may occur during shipment, handling, and storage of drug products. Drive such investigations to resolution in collaboration with Quality, CMO and clinical sites and define and implement procedures to minimize future such occurrences.  Collaborate with QC/QA to define acceptable practices and procedures for handling excursions or deviations from recommended storage and handling conditions based upon review of available stability data.
  • Develop tracking systems to document the genealogy and detailed lot usage history of all drugs for each clinical trial.
  • Working with CMOs, manage the distribution and global depot locations with special considerations on import licenses and shipping lead times for country specific requirements.  
  • Arrange for cost effective return/destruction of all product no longer suitable for clinical use.
  • Meet financial objectives of by forecasting budget requirements; preparing project budget; reviewing CMO proposals, issuing and scheduling expenditures; analyzing change in scope and reviewing Invoices for accuracy.  
  • Responsible for building and maintaining an effective business partnership among internal departments such as Finance and Clinical Operations Departments.
  • Active participation in a variety of team meetings and or committees will be required.
  • Must be willing to travel at least 25%-35% of the time, as measured on a calendar quarter (there may be quarters where travel will be 0%).  Both domestic and international travel may be required.

EXPERIENCE AND QUALIFICATIONS:

  • Project Management skills in multidisciplinary environment with complex strategies and geographical specific requirements and ability to adapt to changes. 
  • Excellent organization skills, ability to lead multidisciplinary teams with excellent oral and written communication skills.   
  • Experienced and successful at developing project budgets, tracking budget expenses, contract negotiation, and various financial operations.  
  • Able to analyze and resolve complex logistical issues in a scientific and heavily regulated GMP environment, considering multiple factors and timelines.  
  • Strong analytical and organizational skills. 
  • Ability to work in a fast-paced environment with competing priorities and frequent tight deadlines is essential.
  • Ability to work on assignments that are complex in nature where judgment is required in solving problems and making routine recommendations. 
  • Demonstrated ability to lead clinical budgeting/forecasting process, summarize results and effective communication of results are required.
  • Attention to detail combined with a high degree of accuracy.
  • Ability to use Excel and Microsoft Word software applications for business correspondence, record-keeping and employee benefits information, meetings, documents and presentations. 
  • Excellent desktop software skills including Excel, Outlook and PowerPoint.
  • Ability to work on assignments that are complex in nature where judgment is required in solving problems and making routine recommendations.
  • Candidate must have a Bachelor of Science degree with one of the following additional degrees preferred; MS or PharmD degree in scientific discipline.
  • Minimum of five  years’ experience working in a Manufacturing or Pharmaceutical Environment, at least two to three years of which directly involve Clinical Supplies/Supply Chain, Clinical Operations, Quality, or CMC role in a Biotech, Pharmaceutical, or CRO company.
  • Significant experience managing and influencing customer demands.
  • Working knowledge of the Clinical Trial Directive and global regulatory environment impacting the provision of investigational products in depth knowledge of R&D supply chain and drug development process.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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98) Clinical Regulatory, Sr. Associate – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) T113DH

DESCRIPTION:

  • Responsible for the coordination, preparation, and submission of a variety of regulatory submissions for biologics and small molecule drug product candidates in several therapeutic indications. 
  • Coordinate the preparation and submission of domestic and international regulatory submissions related to clinical and nonclinical aspects of product development,
  • Coordinate INDs or international equivalents and amendments
  • Coordinate NDAs, BLAs, ANDAs or international equivalents and amendments
  • Coordinate Orphan drug applications
  • Coordinate Information related to clinical trials including protocols, investigator brochures, and investigator information
  • Annual Reports coordination
  • Assist in coordination of meetings with Regulatory Authorities and associated briefing document preparation
  • Attend relevant functional area and project team meetings, including nonclinical and clinical/regulatory subteams
  • Review documents (SOPs, protocols, and reports) related to clinical or nonclinical studies as necessary
  • Other duties as assigned

EXPERIENCE AND QUALIFICATIONS:

  • 2 - 4 years experience in clinical regulatory within a biotech/pharmaceutical environment or equivalent training and experience in related function; preferred 2 years experience in regulatory
  • Proficiency with computer and standard software programs is required
  • Excellent verbal and written communication skills
  • Attention to detail
  • Four year degree in Biology, Chemistry, or other Life Science
  • Advanced degree preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

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99) Principal Genome Scientist – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) AT103J

DESCRIPTION:

  • Provides scientific and technical leadership for the development of the product for rapid identification of disease-causing variants from genome and exome sequencing datasets.  
  • This position also interacts with the community, customers, and key opinion leaders to drive scientific collaborations, grant proposals, and scientific service deliverables that advance the capabilities, customer value and awareness for genome informatics solutions.  
  • The Principal Genome Scientist routinely represents the company as a scientific lead at industry conferences and key customer meetings and events.

EXPERIENCE AND QUALIFICATIONS:

  • Extensive knowledge and background with analysis and interpretation of next generation sequencing data, with direct experience identifying variants driving human disease and/or therapeutic response.  
  • Experience working closely with a software development team is a strong plus.
  • Team player, excellent communicator

To apply for a position send your resume to Jobs@JGBBioPharma.com

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100) Financial Systems Analyst – Contract (Southern California) 73B7399

DESCRIPTION:

  • Duties will include user support for a worldwide user community,  cost Participate in month end activities including system variance analysis and report generation.
  • Tier 1 user support
  • Adhoc data pulls
  • Variance analysis
  • Cost center maintenance
  • Accounting month end close support
  • User security maintained

EXPERIENCE AND QUALIFICATIONS:

  • Strong team player
  • Ability to learn quickly
  • Excellent interpersonal skills with the ability to interact effectively across all levels of the organization.
  • Excellent written and verbal communication skills, with capability to utilize these to build strong business relationships with employees at all levels.
  • Intermediate skill with MS Excel.
  • Any Hyperion Planning, IBM Cognos or HFM experience a plus, but not required
  • SQL stills a plus
  • Strong computer skills (e.g., MS Office, Outlook).
  • Demonstrated ability to set priorities, manage a variety of tasks and projects simultaneously and meet deadlines.
  • Bachelor’s degree in accounting, finance, economics, information systems or computer science

To apply for a position send your resume to Jobs@JGBBioPharma.com

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101) Document Control Specialist – Contract (Southern California) 73Z7582

DESCRIPTION:

  • Administration of the change control system consists of initiating and tracking all incoming, in-process and completed change requests, tracking all associated supporting documentation and following up to ensure the changes are completed and documentation is properly closed out.
  • Communicates with internal customer to collect product related information
  • Manages the change request workflow, which is the vehicle to send request for changes
  • Manages the change workflow, which is the vehicle to execute the request for changes
  • Maintains accurate records of all in-process Product change orders & Document Change Orders (admin function)
  • Provides end-users status updates on their requests
  • Executing product data changes for approved changes orders in site support systems
  • Runs report and queries related to the change management activities
  • Responsible for all changes related to sku discontinuation
  • Initiate Master Data updates as necessary, ensuring completion of corrections.
  • Maintain Quality Records in compliance with ISO Standards.
  • As necessary, evaluates ERP system data to verify accuracy.
  • Will take part in mass data updates as well as ERP system and report modification testing.
  • Provide OJT Training for new team members.
  • May be required to perform other related duties as required and/or assigned.

EXPERIENCE AND QUALIFICATIONS:

  • Requires a minimum of 2 – 4 years relevant experience in a data management, manufacturing, planning, or quality role in a change control environment.  Knowledge of computer applications and current software is desirable (Microsoft Excel, Outlook, Word, Access, Project and PLM/ERP system
  • Works independently on new and on-going assignments
  • Identifies and solves problems using established business rules and procedures
  • Detail oriented
  • Good verbal and written communication skills
  • Continuous improvement minded
  • Comfortable with ambiguity and change
  • Associate’s degree from accredited college/university or equivalent experience.  
  • Applied technical knowledge of PLM and ERP/MRP systems is preferred.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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102) High Throughput (HTP) Scientist – Contract (Southern California) 73Y5670

DESCRIPTION:

  • Apply in-depth knowledge in Molecular Biology to complete services projects or to develop new platform technologies. 
  • Design, plan, and conduct laboratory experiments independently. Job duties will include leading services projects. 
  • Training and guidance of other team members may be also required.
  • Scientist III level employees solve problems associated with their project through application and integration of analytical skills, creativity, and judgment utilizing appropriate scientific principles.
  • Interact regularly with peers, subordinates, and functional peer groups, as well as customers and will present complex problems across functional areas. 
  • Write technical reports, develop protocols, and may give technical presentations to customers or at meetings.
  • All deliverables will impact business performance and operational efficiency.

EXPERIENCE AND QUALIFICATIONS:

  • Molecular Biology techniques (DNA recombinant cloning, qPCR, and DNA/RNA) is required. 
  • High throughput (HTP) experimental setup and hands–on experience using automated instruments is required. 
  • Experience with LIMS or other database managements system are desirable. 
  • Expertise in cell biology is a plus. 
  • The successful candidate should also have excellent organization and communication skills.
  • Hands-on experience using automated instruments
  • Cloning
  • M.S. with 5+ years of relevant experience, or PhD with 2+ years of relevant experience, in Molecular Biology or related discipline.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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103) Senior Manager, Procurement and Planning – Full Time (Illinois) G73SM

DESCRIPTION:

Description:

Responsible for guiding the procurement network in the sourcing of materials, commodities and/or services, ensuring the best leverage of company dollars across multiple sites. Implements proactive procurement philosophies (JIT, PAC, Reverse Auctions, E-Commerce), strategies, policies and procedures for successful integration into multiple business plans across various corporate departments at a Network Level. Manages Buyers and/or Commodity Managers to ensure they continually meet or exceed optimum levels of quality, technology, service and cost of supply base.  Measure against department goals and report performance levels monthly through metrics report card.  


Responsibilities:
 
  • Direct and coordinate activities involving purchasing and distribution of materials, equipment, supplies and services throughout the organization. 
  • Develop quality suppliers who will meet or exceed company delivery, quality, and cost objectives. 
  • Negotiate with suppliers to obtain the best value for the network/organization.  
  • Responsible for meeting inventory goals for purchased material quarterly as well as year-end.  
  • Implements programs and tracking tools to ensure goals are achieved.  
  • Participate and report status to senior management as required at operations reviews. 
  • Requires knowledge of cross-functional businesses within the life sciences group. 
  • Establish, implement, and maintain procedures for maintaining purchasing and supplier quality rating systems. 
  • Prepares reports and required documents. 
  • Determine and enforce, through functional groups, document requirements relating to purchasing and supplier rating system in order to meet internal and external needs. 
  • Evaluate and develop improved techniques for purchasing, expediting and managing the supplier rating system. 
  • Works with Quality, R&D, Production, Marketing, and Accounting to develop new suppliers as required to meet changing demands. Analyze business conditions to determine present and future needs for supplies and materials. 
  • Participate and/or take the lead in departmental and interdepartmental projects. 
  • Report metrics on group performance. 
  • Set an example for effective communications within and outside the department. 
  • Train Purchasing agents/buyers on job duties and perform supervision as necessary or required. 
  • Provide mentoring, coaching, performance reviews and career development  for your team. 
  • This position will require the flexibility to travel domestically and internationally on a routine basis 
  • Other duties  as assigned.

EXPERIENCE AND QUALIFICATIONS:

  • Strong interpersonal, analytical, problem-solving and project management 
  • Experience in managing strategic supplier programs and supplier development.
  • Experience in cost reduction programs.
  • Proven experience in price and contract negotiations.
  • Experience in supplier development.
  • Experience in international sourcing.
  • High standards of integrity.
  • High energy level and strong self-motivation.
  • Must have working knowledge of commonly used concepts, practices, and procedures within a manufacturing environment. 
  • Excellent knowledge of Microsoft Applications 
  • Experience with Lotus Notes, SAP and JDE (E1) preferred.
  • Experience in managing teams remotely
  • Demonstrates excellent leadership and coaching abilities.
  • Good interpersonal skills.
  • Follows and provides direction accurately and efficiently.
  • Excellent documentation and communication skills.
  • Bachelor's degree (B. A.) from a four-year college or university; or five years related experience and/or training; or equivalent combination of education and experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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104) Senior Manager, Procurement and Planning – Full Time (Maryland) B73KQ

DESCRIPTION:

Description:

Responsible for guiding the procurement network in the sourcing of materials, commodities and/or services, ensuring the best leverage of company dollars across multiple sites. Implements proactive procurement philosophies (JIT, PAC, Reverse Auctions, E-Commerce), strategies, policies and procedures for successful integration into multiple business plans across various corporate departments at a Network Level. Manages Buyers and/or Commodity Managers to ensure they continually meet or exceed optimum levels of quality, technology, service and cost of supply base.  Measure against department goals and report performance levels monthly through metrics report card.  


Responsibilities:
 
  • Direct and coordinate activities involving purchasing and distribution of materials, equipment, supplies and services throughout the organization. 
  • Develop quality suppliers who will meet or exceed company delivery, quality, and cost objectives. 
  • Negotiate with suppliers to obtain the best value for the network/organization.  
  • Responsible for meeting inventory goals for purchased material quarterly as well as year-end.  
  • Implements programs and tracking tools to ensure goals are achieved.  
  • Participate and report status to senior management as required at operations reviews. 
  • Requires knowledge of cross-functional businesses within the life sciences group. 
  • Establish, implement, and maintain procedures for maintaining purchasing and supplier quality rating systems. 
  • Prepares reports and required documents. 
  • Determine and enforce, through functional groups, document requirements relating to purchasing and supplier rating system in order to meet internal and external needs. 
  • Evaluate and develop improved techniques for purchasing, expediting and managing the supplier rating system. 
  • Works with Quality, R&D, Production, Marketing, and Accounting to develop new suppliers as required to meet changing demands. Analyze business conditions to determine present and future needs for supplies and materials. 
  • Participate and/or take the lead in departmental and interdepartmental projects. 
  • Report metrics on group performance. 
  • Set an example for effective communications within and outside the department. 
  • Train Purchasing agents/buyers on job duties and perform supervision as necessary or required. 
  • Provide mentoring, coaching, performance reviews and career development  for your team. 
  • This position will require the flexibility to travel domestically and internationally on a routine basis 
  • Other duties  as assigned.

EXPERIENCE AND QUALIFICATIONS:

  • Strong interpersonal, analytical, problem-solving and project management 
  • Experience in managing strategic supplier programs and supplier development.
  • Experience in cost reduction programs.
  • Proven experience in price and contract negotiations.
  • Experience in supplier development.
  • Experience in international sourcing.
  • High standards of integrity.
  • High energy level and strong self-motivation.
  • Must have working knowledge of commonly used concepts, practices, and procedures within a pharmaceutical or device/ diagnostics manufacturing environment. 
  • Excellent knowledge of Microsoft Applications 
  • Experience with Lotus Notes, SAP and JDE (E1) preferred.
  • Experience in managing teams remotely
  • Demonstrates excellent leadership and coaching abilities.
  • Good interpersonal skills.
  • Follows and provides direction accurately and efficiently.
  • Excellent documentation and communication skills.
  • Bachelor's degree (B. A.) from a four-year college or university; or five years related experience and/or training; or equivalent combination of education and experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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105) Sr. Manager, QA / QC – Full Time (Maryland) GA73P

DESCRIPTION:

  • Experienced Quality Leader needed to drive the center of excellence for GMP reagents and complex detection reagents.  
  • Manage a mix of RUO (ISO 13485) and cGMP Quality operations which includes Quality Assurance, Quality Management System, and Quality Control - monitoring and acceptance of incoming raw materials through final production release.  Assure compliance to corporate standards and industry standards.
  • Manage the site Quality Management System including assuring effective management reviews, complaint handling, CAPA system, change control, calibration maintenance, internal auditing, R&D transfers, and manufacturing area support.
  • Responsible for the continued development GMP capability and maintenance of compliance to US FDA Quality System Regulations (QSR, Part 820)
  • Ensure effective transfers of new products into production that meet all the Quality requirements for the classification.
  • Coordinate the development of action plans when corrective steps (CAPA) are required and implements these through the site steering team.  Responsible for routinely managing, tracking and reporting Critical Success Factor metrics to support plant Quality initiatives.
  • Ensure site wide training is effective and that the plant operates within the required regulatory guidelines by examining and testing plant-wide processes and products from a final product acceptance and compliance perspective. 
  • An the GMP center of excellence – assist in overall GMP strategy, best practices, and guidance across multiple GMP sites across the globe

EXPERIENCE AND QUALIFICATIONS:

  • Requires thorough knowledge of cGMPs for medical devices or pharmaceuticals.
  • FDA audit experience with successful outcomes 
  • Effective communication skills are required, both written and verbal. 
  • Problem solving skills are required in situations that are not procedurally managed. 
  • Knowledge of the pharmaceutical GMP regulations and their appropriate application is needed to assure compliance with regards to manufacturing problems. 
  • Analytical ability is required to make competent decisions based on a review of analytical data
  • Bachelor's Degree in Scientific/Technical field (i.e. Chemistry, Biology, or Engineering). 
  • A minimum of 5-10 years of management experience in a GMP or similarly regulated facility.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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106) Senior Director Clinical Development, Respiratory – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) H111BV

DESCRIPTION:

  • Plan and manage the implementation of clinical development plans required for evaluating the efficacy and safety of investigational drugs and biologics.  
  • Medical monitoring activities associated with the management and oversight of Phase II trials, leading to Phase III trials. 
  • The therapeutic areas of interest include respiratory and oncology.  
  • This position reports to the CMO
  • This position will have an Associate Medical Director as a direct report
  • Strategic clinical trial input to the clinical operations team
  • Investigator selection and evaluations
  • Evaluation of safety data from clinical trials and reports safety findings to regulatory authorities and licensing partners
  • Supports writing efforts on clinical study reports
  • Identifies and maintains liaison with leading investigators in the areas of medicine where products are being developed
  • Reports clinical study findings at professional meetings
  • Involves project teams to identify clinical indications appropriate for investigational drugs

EXPERIENCE AND QUALIFICATIONS:

  • At least 10 years of experience in drug development in the biotechnology or pharmaceutical industry; respiratory experience strongly desired
  • Experience being the Medical strategic lead on Phase 2 or later stage clinical trials.
  • Direct report management experience
  • In depth knowledge of clinical trial design, data interpretation and analysis and the ability to analyze, interpret, and report clinical trial findings
  • Effective oral and written communication skills
  • Strong interpersonal skills and ability to work effectively with project teams
  • Medical Doctor degree, board certified

To apply for a position send your resume to Jobs@JGBBioPharma.com

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107) Senior Java Server Developer - Bioinformatics – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) P103LA

DESCRIPTION:


  • Looking for an experienced server-side developer who has a good eye for software architecture and API design, and a proven track record of building scalable bioinformatics / scientific software systems for big data analysis workflows in genomics and life sciences. 
  • This position will help build out the industry-leading genomic data analysis cloud platform for large scale scientific and clinical data analysis and management. 
  • Experience with genomics, bioinformatics and life sciences is required.
  • As a senior back end developer, you will develop software and infrastructure used to deliver the  cloud-based product line to a global community of researchers, scientists, clinicians and medical geneticists. 
  • Work closely with our scientific product leads, bioinformaticians, and front end developers on developing big data management frameworks, tooling, applications and reporting / visualizations that support large-scale, sophisticated data analysis and interpretation of genomic and genetic data. The solutions you develop will be used by molecular biologists, clinical geneticists and researchers, and biomedical informaticians, and will fundamentally enable the application of technologies for the improvement of human health.
  • A good fit would be a rock star Java developer with an aptitude for tackling complex data processing, analysis and workflow challenges in the life sciences. You will need a strong analytical mindset and a talent for executing quickly while still following best practices and who thrives on new technology and has an avid interest in bioinformatics and genomics. Use a hybrid web stack, with mostly Java on the back end but some Python and Perl as well. You will be expected to help make decisions on server-side library and framework usage, including both generic software frameworks as well as ones focused on life sciences and bioinformatics, as well as scaling our distributed computing cloud configuration supporting large scale data management and processing for our customers around the world.

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor’s or Master’s Degree in Bioinformatics, Computational Science, Biological Life Science
  • 5+ years of recent Java development experience – this is a primary requirement.
  • 5+ years’ working experience involving Bioinformatics software bioinformatics tools and biological databases
  • 3+ years’ experience building NGS pipelines for processing human sequencing data from at least Illumina and Ion Torrent platforms
  • 3+ years working in a team-based agile development environment
  • Familiarity with Linux required, experience with Python and Bash scripting preferred
  • Understanding of Next Generation Sequencing technique and expertise with NGS bioinformatics tools such as GATK, Bowtie, etc
  • PhD in Bioinformatics or Computational Science preferred
  • 8+ years bioinformatics development experience in a research or translational setting
  • Experience working with both DNA-Seq and RNA-Seq data
  • Experience with commercial and open source NGS pipeline infrastructure tooling and cloud infrastructure like Amazon Web Services, Heroku, etc
  • Strong experience with Python language and libraries; 3+ years applying Python scripting to bioinformatics preferred
  • Strong communication skills and willingness to ask a question. We do not typically assign 100% specced-out tasks that always must be implemented an exact way; you'll be given a business problem to solve for the user, and expected to understand and explore the space of design alternatives to come up with a good solution, using rapid prototyping to test your design hypotheses. Questions will occur and it is important that you be comfortable asking them and chasing down answers.
  • Know how to optimizing complex distributed software systems in a cloud deployed environment.
  • Strong believer in version control tooling and know your way around git and Github.
  • Resourceful and can pull down a Java or Python project and get running on development the same day.
  • Like working with teams on large apps where modularity, performance, flexibility, maintainability, and API integration are fundamental concepts that inform your code and architecture decisions.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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108) Senior Front End Developer for Bioinformatics – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) FB103T

DESCRIPTION:

  • Will lead front end development on the DataStream tools used to deliver the entire company product line to the customers, and to integrate products and platform technology into a wide range of scientific workflows across academia, pharma, biotech and clinical settings. 
  • Will work closely with the scientific product leads, bioinformaticians, and back end developers on developing tools and visualizations that support large-scale, sophisticated data analysis and interpretation. 
  • The solutions you develop will be used by molecular biologists, clinical geneticists and researchers, and biomedical informaticians, and will fundamentally enable the application of company technologies for the improvement of human health.
  • A good fit would be a developer who can execute quickly while still following best practices and who thrives on new technology and has an avid interest in bioinformatics and genomics. Using a hybrid web stack, with mostly Java on the back end but some Python and Perl as well. 
  • Expected to help make decisions on front-end library usage, front-end and javascript architecture, and lead implementation of CSS, HTML and JS. Help evaluate and select modern tooling (such as SASS, Coffeescript, Grunt) and selectively apply techniques in the space (such as Raphael, D3, Backbone). 
  • Talented front-end developer who writes clean, well-organized CSS and HTML and composes Javascript beyond the walled garden of JQuery.

EXPERIENCE AND QUALIFICATIONS:

  • A bioinformatics degree is not required for this position, but experience building web-based user interfaces or information visualizations for biomedical researchers, scientists and clinicians is a must.
  • Exceptional HTML5, CSS and JavaScript skills, JKQuery
  • Experience working with Java backends a must; Java software development experience strongly preferred.
  • MVC, SVN, Linux command line
  • Demonstrated ability to quickly and independently implement MVC sites using Bootstrap or similar frameworks.
  • Strong attention to detail and visual design -- please expect to show your portfolio
  • Bonus: experience with CoffeeScript, SASS, Django and similar
  • Bonus: experience with JS app and visualization frameworks: EmberJS, Angular, Backbone, D3
  • Strong experience with MVC client-side libraries, having done one or more substantial projects with a framework such as Backbone or Ember.
  • Experience : built web applications that involve multiple user roles working together in a multi-step workflow
  • Have demonstrated design skills for rich data-driven web apps
  • Projects to identify what’s missing or unworkable in a wireframe or high-level set of design requirements, and have the basic design and UX chops to improvise when necessary.
  • Strong communication skills and willingness to ask a question. 
  • Expected to understand and explore the space of design alternatives to come up with a good solution, using rapid prototyping to test your design hypotheses. 
  • Know how to optimizing website resources and front-end performance for data-heavy Javascript apps
  • Should be comfortable and effective using SASS (or LESS, Stylus, etc.) and know your way around Grunt, Bower, etc. Coffeescript tolerance is a plus.
  • Well-versed in the classic front end skills as well - you know your meta tags, SEO basics, and analytics / user tracking, and can deal with IE8 etc. should the unfortunate necessity arise.
  • Version control tooling and know your way around git and Github.
  • Resourceful and can pull down a PHP or Ruby project and get running on development the same day.
  • Like working with teams on large apps where performance, responsive design and API integration are fundamental concepts that inform your code and architecture decisions.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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109) Director / Executive Director, Regulatory Affairs – Full Time (Boston Area) GR110B

DESCRIPTION:


  • Responsible for developing innovative global regulatory  strategies  for  program  and  leading  the  preparation,  submission  and approval  of marketing applications. 
  • Responsible for managing interactions with health authorities and for ensuring that regulatory documents are in compliance with health authority regulations.
  • Develop and implement creative regulatory strategies aimed at achieving marketing authorization and appropriate product labeling. Ensure cross functional alignment on regulatory plans and strategies
  • Responsible for the timely production and submission of regulatory documentation, including investigational and marketing applications (IND, CTA, NDA, MAA etc.) in compliance with global regulatory agency requirements
  • Serve as primary liaison with regulatory authorities, including overseeing the writing of pre-meeting briefing materials, leading the preparation for meetings with regulatory agencies, and ensuring appropriate follow-up
  • Review Clinical study protocols, Clinical study reports, Investigator brochures, safety reports, Annual reports, CMC reports and regulatory submissions
  • Maintain regulatory expertise and serve as internal consultant on relevant global regulations and guidelines, current regulatory environment and regulatory precedent

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor’s degree in a scientific discipline, Advanced degree (PhD, MS) preferred)
  • 7+ years of pharmaceutical industry experience required. At least 4 years of regulatory affairs with experience associated with global submissions.
  • Must have comprehensive understanding of global regulatory requirements for registration, development and approval of investigational products
  • Excellent knowledge of global regulatory requirements and processes and filing experience (IND, CTA/NDA/MAA)
  • Strong interpersonal, communication, and leadership skills
  • Ability to review regulatory and scientific submission documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies
  • Demonstrated leadership and people management skills in team and departmental settings
  • Excellent organizational, prioritization and planning skills. Ability to work independently on projects and initiatives internally and with external vendors

To apply for a position send your resume to Jobs@JGBBioPharma.com

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110) Sr. Director, Clinical Regulatory – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) EH113K

DESCRIPTION:

Summary:

Directs the clinical and nonclinical aspects of the global development of early and late-stage drug candidates, both biologics and small molecules, providing strategic direction and senior-level regulatory expertise.  Oversees and mentors multiple direct reports to achieve regulatory objectives in line with corporate goals.  Ensures positive interactions with corporate partners.  Leads due diligence, regulatory intelligence, and regulatory affairs initiatives.  Supports development and implementation of department policies.

Responsibilities:

  • Defines the clinical and nonclinical regulatory strategy supporting efficient drug development for early and late-stage products
  • Oversees planning, preparation, and submission of clinical trial applications and marketing applications in the US and internationally
  • Oversees maintenance of approved products and supports global commercialization of these products
  • Oversees all clinical and nonclinical interactions with global regulatory authorities
  • Manages and mentors multiple direct reports
  • Supports executive team on due diligence, regulatory intelligence, and regulatory affairs initiatives
  • Serves on senior staff committee responsible for developing and implementing department policies

EXPERIENCE AND QUALIFICATIONS:

  • Prior oncology experience is preferred. 
  • Rare disease experience is a plus.
  • Prior experience in filing marketing applications, obtaining approvals, and maintaining the licenses for drugs and/or biologics
  • Skilled at gathering regulatory intelligence and developing product approval strategies
  • Excellent skills in managing multiple regulatory affairs professionals
  • Proven ability to successfully interact with regulatory authorities
  • Prior experience in filing global marketing applications and with advertising and promotion regulations is desirable
  • Prior experience with both biologics and small molecules is desirable
  • At least 12 years of experience in Regulatory Affairs in the biotechnology or at least 8 years of experience in managing regulatory staff
  • Minimum of B.S. degree in life sciences or equivalent; advanced degree preferred.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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111) EHS Coordinator – Contract (Southern California) 1461D73

DESCRIPTION:

  • Assist in development of training programs
  • Assist in the implementation of EHS programs for chemical handling, biosafety, hazardous waste, electrical safety, industrial hygiene, radiation, lasers and facilities maintenance programs.
  • Assist in the management of safety committees.
  • Assist with the site emergency response team.
  • Track site environmental, health and safety metrics
  • Assist in the maintenance of the incident management database
  • Assist in the updates to the EHS inspection program and tracking corrective actions 

EXPERIENCE AND QUALIFICATIONS:

  • Requires minimum of a Bachelor’s degree and 3 years of experience in an environmental, health and safety related discipline and technical/practical knowledge of EHS regulations, codes and guidelines.  
  • Experience in OSHA’s VPP is strongly preferred.  
  • Requires a bachelor’s degree in safety engineering, environmental or industrial hygiene or comparable field; or the equivalent knowledge and experience.  
  • Must have working knowledge of federal and local EHS regulations, including OSHA and EPA. 

To apply for a position send your resume to Jobs@JGBBioPharma.com

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112) Manager, Clinical Operations, Oncology – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) HL113W

DESCRIPTION:


Responsible for managing operational activities of assigned clinical programs. Provides a level of expertise, aligned with the principles and standard practices for operational activities of clinical trials. Act as the lead for assigned projects and provide regional insight to global projects where applicable. Responsible for CRO training, management and agreements related to CRO clinical activities. Partner with key stakeholders internal and external to ensure continuous harmonized operations of global activities and to maintain high standards for functioning in a matrix environment.

Responsibilities:
  • Responsible for representing Operations on cross-functional study teams and vendor, CRO operational meetings and ensuring compliance with global operational standards and procedures
  • Manages cross-functional study teams and vendor operational meetings to ensure compliance with  operational responsibilities
  • Provide leadership for Operations related issues and advise management team of potential issues and solutions
  • Manage, coach and develop junior staff in order to maximize their capability and contribution to provide high quality deliverables
  • Responsible for the review and oversight of  responsibilities in study data management plans for  operations and operational responsibilities associated with all clinical trials
  • Responsible for ensuring that all  components of the trial master file are up to date and accurate for assigned investigational trials
  • Monitor global regulatory intelligence for global industry practices for operational efficiency and compliance
  • Responsible for operational guidance for investigators and provide CRO training related to  the study conduct
  • Responsible for managing  queries for clinical studies from CROs
  • Participate in the conduct of audits and Inspections related to Operations
  • Address consistency in collection, processing and evaluation of clinical data, contribute to the development of global SOPs and policies to ensure compliance with regional regulatory requirements and to drive improvements in global processes
  • Represent Clinical Operations on global teams as an operation owner and/or function as a vendor relationship manager for vendors
  • Support sponsored clinical trials and development program

EXPERIENCE AND QUALIFICATIONS:

  • Previous experience working in global environment
  • History of successfully developing effective relationships with outside vendors and CROs
  • Outstanding verbal communication skills which resulted in professionally communicating and guiding individual and team efforts related to Clinical Operations
  • Demonstrated skills in negotiation, multi-tasking, organization and decision making
  • Proficiency in databases, coding and data mining methodologies we well as Microsoft applications
  • Ability to travel to global sites required.
  • Prior experience working on cross-functional teams in a lead capacity
  • Minimum of 4 years oncology clinical trial experience
  • Minimum 5years experience in Clinical Operations: working with CROs and other vendors
  • At least 5 years of management experience in a clinical research environment
  • A Bachelor of Science / Masters prefer

To apply for a position send your resume to Jobs@JGBBioPharma.com

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113) Senior Clinical Research Associate – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) GT113P

DESCRIPTION:

  • Participates in the planning, management and execution of clinical studies, with a strong focus on data quality, risk mitigation, enrollment, investigator/site relationships, and general project oversight in compliance with Regulatory Authorities’ regulations/guidelines andStandard Operating Procedures and Work Instructions.
  • May lead cross-functional study team(s) and/or sub-team(s)
  • Prepares content for training materials and coordinates training on study procedures
  • Prepares operational plans and defines study-specific working practices
  • Contributes to the development study execution plans and risk management plans
  • Develops, manages, and maintains relationships with external partners
  • Serves as study manager for the functional area in managing protocol execution
  • With input from therapeutic area Development Sciences Team, contributes to the development of study documents including protocols, informed consent forms, and study manuals
  • Oversees setup and management of the CTMS and TMF
  • Participates in country and site selection
  • May manage feasibility studies
  • Reviews feasibility data
  • Liaises with vendors to ensure quality site selection
  • Participates in preparation of RFP assumptions and SOW
  • Contributes and reviews specs for affiliated vendors (IVRS, labs)
  • Oversees all aspects of clinical vendor management (performance, quality, timelines, deliverables, etc.)
  • Provides input, reviews, and approves vendor study specifications
  • Ensures appropriate escalation of issues in timely and efficient manner
  • Participates in design and approval of various project and communication plans
  • Reviews essential regulatory documents
  • Prepares, reviews, approves and assures adherence to Monitoring Plan
  • Reviews eCRF specs (EDC), CRF completion guidelines and Data Management documents, as needed
  • Contributes to the development and review of Clinical Data Review Plan
  • Designs, reviews and approves study tools (for investigative site use)
  • Plans/organizes/leads investigator meetings
  • Contributes to the preparation and review of materials for Investigator Meetings and CRA training
  • May provide oversight of country regulatory approvals (e.g. CTA, MoH) and country/site IRB/EC approval
  • Reviews regulatory packages (essential documents - blank forms and templates for 1572s, financial disclosure, etc.),
  • Authorizes investigational product shipment to investigational sites
  • Reviews and approves informed consent forms (e.g. site or country specific ICFs)​
  • Ensures enrollment is tracked and recorded appropriately
  • Contributes to the development and maintenance of recruitment strategy
  • Addresses enrollment and retention issues
  • Provides oversight of clinical monitoring to ensure quality data (in-sourced or out-sourced),
  • Reviews monitoring trip reports to demonstrate oversight
  • Reviews study data as defined by Study Team
  • Follows up on trending outstanding eCRFs and data queries
  • Performs oversight and co-monitoring visits to ensure data integrity
  • Oversees resolution of study conduct issues
  • Ensures ongoing reconciliation of TMF
  • Monitors GCP/ICH site level compliance
  • Manages/oversees study and vendor close out activities
  • Oversees the completion of all archiving and final TMF reconciliation and transfers as required

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor’s degree in biological science preferred.
  • Combination of educational and work experience providing competencies to perform the required accountabilities specific to position
  • 4-6 years industry experience, including a minimum 4 years clinical research experience with 3 years experience working with solid tumors:
  • Possesses record of strong therapeutic experience
  • Ability to relate to and discuss disease and treatment process
  • Can demonstrate core knowledge of RECIST and stand of care within disease area.
  • Line management and/or mentoring experience of Jr. CRAs and Clinical Assistants:
  • Mature monitoring/mentoring skills expressed by calm and thorough review of situations. Proactively identifies and/or addresses problems. Seeks to understand all contributing factors. Proposes, implements, and evaluates appropriate resolution.
  • Exhibits significant positive participation:
  • Takes direction well
  • Possesses the ability to define and meet requirements
  • Displays flexibility for improvement and creating solutions.
  • Demonstrates high proficiency and extensive experience managing large scale vendors (CRO, Central Laboratories, IXRS, etc.)  in a global environment
  • Ability to function independently, take initiative and collaborate in process improvement activities and teams
  • Ability to constructively influence the decision making process
  • Timely escalation of issues with solution based approach
  • Adequate identification of key stakeholders and decision makers throughout
  • Demonstrates, by example, proactive problem solving abilities and follow through
  • Exhibits proficiency in all aspects of monitoring, co-monitoring, teaching, and training
  • Strong experience with EDC and upfront data quality implementation procedures specific to the protocol under study
  • Understanding of the clinical development plan and how the individual projects are impacted
  • Ability to travel is required
  • Displays strong written and verbal communication skills
  • Proficient with Microsoft Office Suite Software

To apply for a position send your resume to Jobs@JGBBioPharma.com

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114) Scientist II / Senior Scientist Pharmacokinetics/Pharmacodynamics – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) F113KV

DESCRIPTION:

Summary:

Responsible for the design, execution, interpretation and reporting of clinical pharmacology and clinical/nonclinical pharmacokinetic/pharmacodynamic (PK/PD) studies. This includes the assessment of PK/PD relationships of recombinant protein and small molecule drug candidates that are situated throughout all stages of development  (Phase 0-IV).  The individual will assess and recommend dose levels and regimens for molecules in Phase 0-IV clinical development (including new indications for existing therapeutics) by working in close partnership with medical directors, clinical scientists, biostatisticians, bioanalytical research scientists, pharmacologists and toxicologists, , formulation and process scientists, and project teams. This assessment will require modeling, simulations and predictions of PK and PD, and make recommendations on dose regimen for drug candidates in clinical development.  Population PK/PD and exposure-response analysis of drug candidates will be conducted as the programs progresses in clinical development..   The individual will be responsible for the planning, implementation and organization of regulatory filings along with presentation of PK/PD data to internal cross-functional teams, external collaborators, US and ex-US regulatory authorities and the scientific community.    

Responsibilities:
  • Design and interpret PK/PD studies in support of molecules in clinical and nonclinical development.
  • Model, simulate and predict nonclinical and clinical data to drive decisions on dose and frequency of dosing
  • Perform population PK analyses on drug candidates as they progress through clinical development
  • Provide expert PK/PD advice to cross-function project teams
  • Interact with pharmacologists, toxicologists, medical directors and regulatory affairs personnel for the timely completion of clinical and nonclinical studies and regulatory filings.
  • Represent the Pharmacological Sciences Department on multi-disciplinary drug development teams and lead departmental sub-teams.
  • Interact with external collaborators, multi-company project teams regarding and outside contractors
  • Write reports, sections to INDs, NDAs, etc. and publish findings at the appropriate time

EXPERIENCE AND QUALIFICATIONS:

  • Desire to work in a position focused specifically on modelling and pharmacokinetics
  • Strong background in quantitative clinical pharmacology analysis, pharmacokinetics and/or statistics with extensive knowledge of drug development process
  • Hands-on experience with population PK/PD and exposure-response analysis using NONMEM/R/SPLUS software in clinical drug development
  • Hands-on experience with non-compartmental and compartmental PK/PD analysis using WinNonlin
  • Excellent writing and verbal communication skills both cross-functionally as well as outside to various regulatory agencies.
  • Hands-on experience with preparing clinical pharmacology/PK/PD related sections in regulatory submissions (i.e., IB, IND, NDA, MAA, BLA) preferred.
  • Clinical pharmacology and clinical/nonclinical PK/PD study design, implementation and interpretation; experience in modeling and simulation
  • Experience with GLP procedures and documentation or equivalent familiarity with FDA guidance’s.
  • In vitro/in vivo ADME experience preferred
  • Pharmacokinetic experience with biologics and the associated immunogenicity issues is a plus.
  • At least 2 years experience for Scientist II or 5 years for Sr. Scientist of industry experience.
  • Ph.D. in a pharmaceutical science, bioengineering or related field.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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115) Associate Director, Project Management – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) BL140Y

DESCRIPTION:

Summary:

A team leader who will be an influential individual within our organization, responsible for providing project management planning and guidance to support in market (commercialized)  and late clinical development stage programs. This individual will be a key member of project teams, working closely with Project Leaders, team members from multiple functions including Marketing, Sales, Medical Affairs, Business Development, Manufacturing, Regulatory and Financial Planning and Analysis as well as senior management. For partnered programs, this individual may be required to assume alliance management responsibility in addition to providing Project Management support.

Responsibilities:        
  • Planning – Ensure team objectives are clearly established and communicated. Create and maintain project plans and timelines, organize and conduct project team meetings as required. In combination with project leaders, ensure that project objectives are clearly established and agreed with the project team and management. Monitor the progress of project teams and update/adapt project plans as necessary.
  • Financial planning – partner with Finance to define project activities/timelines to drive quarterly forecasting and annual budget planning rounds.
  • Risk Analysis and Problem Solving – identify risks, opportunities, issues and constraints. Plan risk mitigating activities and facilitate resolution of issues and corrective actions as necessary.
  • Resource Utilization – Ensure that adequate resources are available and effectively allocated for maximum efficiency and productivity, highlight resource constraints/shortages to management.
  • Communication – Ensure that management is kept apprised of team achievements and progress against plans. Regularly communicate project status including expectations, opportunities and risks. Reporting will occur via regular written communication as well as organized presentations, discussions and informal interactions with management and stakeholders.
  • Organizational Development - Identify and lead opportunities for business process design and improvements.

EXPERIENCE AND QUALIFICATIONS:

  • In-depth operational and strategic understanding of pharmaceutical research and early development projects gained through active project experience.
  • A track record of successful leadership roles in pharmaceutical projects either through formal leadership positions or across a matrix.
  • Demonstrated ability to work in teams, build strong relationships and influence across functions.
  • Very strong written and oral communication skills. (Candidates may be asked to deliver a presentation as a part of the interview process.)
  • Very strong planning skills. 
  • Familiarity with planning and visualization tools such as MS Project is desired.
  • Advanced degree in life sciences or business (or equivalent industrial experience).
  • High energy level, personal productivity, creativity and commitment. 
  • Able to provide mentorship to junior staff as necessary; no direct reports

To apply for a position send your resume to Jobs@JGBBioPharma.com

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116) Director / Sr Director, International Operations – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) G127KM

DESCRIPTION:

The Senior Director, International Operations will develop and execute early access programs.  The role reports in to the Vice President, Commercial Development.  This opportunity includes all activities related to facilitating drug access prior to commercialization efforts, registration, and/or broad product availability.

Responsibilities:
  • Establishing early operations and in-country support for NPP (Named Patient Programs)
  • Lead the efforts of a matrix team toward providing access to patients
  • Ensure expeditious product release in each market
  • Design, document and implement required NPP processes
  • Coordinate due-diligence efforts across all functions including other Commercial managers,  PV, Manufacturing, Compliance, Quality, Legal, Finance, Medical and Regulatory
  • Identify, select and contract with local partners and local consultants
  • Coordinate training for all external parties, including but not limited to product, disease, market access and adherence programs
  • Manage partners
  • Manage all ongoing early access programs
  • Establish performance metrics for each partner/consultant
  • Partner with local resources, if available
  • Oversee contract execution and management for all partners
  • Adapt global patient adherence programs to local markets
  • International Operations Strategy & General Responsibilities

EXPERIENCE AND QUALIFICATIONS:

  • The successful candidate will have 10+ years’ experience in biotech or pharmaceuticals, including work with highly specialized, small market pharmaceutical products
  • 5+ experience or at least two product launches in international markets
  • Experience with commercial and NPP pathways to product access
  • Minimum of bachelor’s degree in a science or technology, advanced degree preferred
  • Experience with local regulatory and pricing/reimbursement authorities
  • Able to drive performance in a multi-disciplinary environment
  • Comfortable working concurrently in multiple countries and regions
  • Domestic and global travel required 50-75%
  • Relocation assistance not provided.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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117) Scientist II, III - Protein Chemistry – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) GR139H

DESCRIPTION:

  • The successful candidate will have a track record of success in the discovery, design, and optimization of antibodies and ECD-fc fusions with therapeutic potential.  
  • Experience developing and optimizing bi-specific antibodies is a plus. 
  • Strong leadership skills are required and the ability to work closely with a cross functional team of discovery biologists is required. 
  • The selected candidate will be a hands-on manager of direct reports and is expected to work at the bench as needed.

EXPERIENCE AND QUALIFICATIONS:

  • Experience with multiple classes of therapeutic proteins, including antibodies, bi-specifics, receptor-Fc fusions, and secreted proteins is desirable
  • Experience with antibody selection, humanization and optimization is desired
  • Experience in protein modeling, structure-function mutational analysis, and protein engineering is a plus
  • Experience with high throughput instrumentation and automation technologies is preferred.
  • Excellent written and verbal communication skills, organizational skills, collaboration skills, and computer skills are required
  • The ideal candidate will have a proven track record of scientific and technological innovation, a significant reputation as an outstanding scientist in his/her field, and an eagerness to work as part of a team discovering new therapeutics 
  • Passion for protein discovery, design and optimization to generate first-in-class therapeutics
  • Broad understanding of protein science, including expression, purification, and characterization
  • Familiarity with high throughput technologies for production and functional testing
  • Excellent leadership skills
  • Collaborative spirit with creative intuition for generating next generation technologies 
  • Ph.D in a biochemistry or related discipline required with 5-8 years laboratory research experience
  •  

To apply for a position send your resume to Jobs@JGBBioPharma.com

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118) CRA III / Sr CRA – Clinical Operations – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) MB139W

DESCRIPTION:

Individual will play a key role in assisting the Clinical Development team in conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. The primary skills include logical thinking, ability to prioritize, “can-do” attitude, the ability to adapt quickly to changing business conditions, strong interpersonal and team building skills. Looking for candidates that are able to recognize and synthesize information about the organizational climate and partner with key individuals to accomplish organizational goals. Overall responsibilities may include the management of clinical operations activities and coordinating cross functional efforts in the administration and progress of a clinical trial(s) in order to achieve trial objectives and corporate goals.

Primary Responsibilities
  • The candidate, working closely with the cross functional team, under direction of the Associate Director, Clinical Operations, will have overall responsibilities for managing the full scope of clinical trials and coordinating efforts in order to achieve study objectives and corporate goals, including:
  • Implementation of clinical trial activities. May act as a global clinical trial lead to solicit RFPs and assist in identification of optimal CRO and manage CROs, clinical site personnel, and other study vendors. 
  • Assisting with managing defined aspects of clinical trials to ensure trials are initiated efficiently and completed on time, within budget and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines. 
  • Track key study metrics using tracking tools (creating and maintaining documents, tables, databases, spreadsheets and files), providing timely and quality updates to the study team.
  • Travel for site monitoring and/or co-monitoring activities, attend investigator meetings or vendor visits/audits, as required (up to 50%).
  • Create and/or review monitoring reports and monitoring visit letters. 
  • Assist clinical study sites with IRB/EC submissions and ensure collection and review of required essential study documents and reports. 
  • Work proactively with data management team in the design and development of eCRFs. 
  • Review completed eCRFs for accuracy.  Oversee data discrepancy management and retraining as needed. 
  • Develop strong working relationships and maintain effective communication within the development department as well as other functional departments within the company.
  • Provide or assist with training internal and external CRAs, CRO team members, and investigative site staff. 
  • Ensure that supportive study supplies and documents are available (e.g., contracts, IXRS, lab kits, non-clinical supply materials). 
  • Perform on-going review of the TMF to ensure files are properly maintained and up to date, archived and stored. 
  • Attend meetings, take and distribute meeting minutes.  

EXPERIENCE AND QUALIFICATIONS:

  • Global trial and CRO management experience is preferred.  
  • Proficiency with word processing, spreadsheet, database, and presentation software (MSOffice skills such as Outlook, Word, Excel, PowerPoint) and with filing systems.  
  • Oncology experience preferred but not required. 
  • BS/BA in Life Science or related discipline 
  • 5+ years industry experience in drug development, including prior on-site monitoring experience

To apply for a position send your resume to Jobs@JGBBioPharma.com

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119) Clinical Trial Manager – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) A129DK

DESCRIPTION:

Responsible for the operational management and oversight of clinical trials within a clinical development program; the level of independence and scope of responsibilities assigned may vary depending on the experience of the successful candidate.  The CTM will work closely with the Medical Monitor and other cross-functional representatives, including Clinical Data Management, Biostatistics, Regulatory/QA, Pharmacology, Biology to ensure successful completion of all clinical activities/project deliverables within the required time frame and budget. Will also provide oversight of the CRO and other third party vendors on assigned study. This individual will report into the Director of Clinical Operations. This is an in-house position.  
 
  • Oversee performance of CROs, third party vendors, and field CRAs  including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to Director or CRO as appropriate 
  • Perform clinical data review of data listings and summary tables, including query generation   
  • Identify, select, and monitor performance of investigational sites for clinical studies; prepare accurate and timely visit reports from all site interaction visits 
  • Develop and maintain good working relationships with investigators and study staff 
  • Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study specific manuals and procedures 
  • Track and report on progress of study including site activation, patient enrollment, monitoring visits 
  • Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team (autonomy may vary with experience)  
  • Investigate queries, monitor discrepancies 
  • Manage investigational product (IP) accountability and reconciliation process 
  • Responsible for review or approval of IP release packages 
  • Negotiate and manage the budget and payments for investigative sites, if applicable 
  • Write or contribute to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents 
  • Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work 
  • Assist with CRA and third party vendor training on protocols and practices  
  • Assist in identification and hiring of appropriate CROs and third party study vendors  

EXPERIENCE AND QUALIFICATIONS:

  • Experience in managing industry sponsored clinical (pharmaceutical) trials.  
  • Cross-functional team leadership experience preferred (at least 2 years)  
  • Management of international clinical studies preferred 
  • Cardiovascular and/or oncology study experience preferred  
  • Experience managing vendors, including performance assessments and total financial management (invoice review, change order management, budget reforecasting, etc.) 
  • Previous experience working with an electronic data capture system and CTMS system required  
  • Proficient with MS Word, Excel and PowerPoint.  Experience with MS Access and MS Project a plus 
  • Strong interpersonal, communication (written and verbal), and organizational skills  
  • Demonstrated ability to work independently as well as part of a multi-functional study team  
  • Able to motivate a team to work effectively under a changing environment  
  • Able to solve problems under pressure  
  • Self-motivated and able to work effectively in a matrix/team environment  
  • Availability for potential travel domestically and internationally 
  • Clinical operations work experience in the pharmaceutical industry and working knowledge of GCP/ICH guidelines and the clinical development process. 
  • Global Phase III experience in cardiovascular or oncology drug development desirable. 
  • Bachelor’s degree or equivalent 

To apply for a position send your resume to Jobs@JGBBioPharma.com

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120) SCRA / CTM (Clinical Operations) – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) DH125N

DESCRIPTION:

  • Manage the execution of multiple clinical programs
  • Manage sites and vendors to assure successful execution of multiple clinical studies (Phase I through IV) from an operational standpoint: timeline, scientific quality and budget perspective with adherence to intra-company and ICH/FDA regulations and guidelines.
  • Act as point person for sites and external vendors; proactively supervise internal CRA(s), other functional teams, and external vendors, including central labs, and IRB
  • Assist CRA on site identification, selection, and qualification
  • Prepare for clinical trial materials, TMF, site regulatory bind,
  • Manage central IRB submission and approval and drug shipment
  • Prepare for SIV
  • Manage advertising program
  • Track trial activities including study timelines, budgets, and quality of the trial/program conduct
  • Maintain the day-to-day communication among sites and vendors
  • Prepare for all reports/documents, e.g., monthly reports, meeting minutes, enrollment reports, monitoring reports, investigator payments and invoices
  • Act as the primary person for resolving emerging issues and problems during the study
  • Oversee SAE report and coordinator activities with Medical Monitor
  • Communicate the study status and issues to the internal project team and sponsor
  • Implement Phase I-IV trials and perform co-monitoring as appropriate.
  • Ensure the integrity and validity of all data by thoroughly reviewing all documentation and by identifying areas of concern throughout the study process.

EXPERIENCE AND QUALIFICATIONS:

  • Preferred experience as both in-field and in-house monitoring, with either previous experience working for or supervising CRO activities, with preferably two years or more trial management experience .
  • Excellent written and verbal communication skills.
  • Ability to use a systematic approach in solving problems through analysis of problem and evaluation of alternate solutions.
  • Life science degree (BS, RN, or higher).
  • Minimum 7 years pharmaceutical clinical trials experience (may include combination of investigative site, CRO, pharmaceutical CRA experiences).

To apply for a position send your resume to Jobs@JGBBioPharma.com

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121) Engineering Technician – Contract (San Francisco Bay Area) 73G4864

DESCRIPTION:

  • Performs maintenance, testing, troubleshooting, calibration and repair on a variety of manufacturing and testing Instrumentation.
  • Carries out routine repairs on a daily basis.
  • Provides technical support to internal customers on operational or maintenance aspects of system equipment.
  • Works independently and prioritizes work schedule of service calls a majority of the time, may require direction from Lead or Supervisor sporadically.
  • Maintains own tool inventory to ensure adequate supply to perform duties.
  • Works with team and administrator to assure there is adequate supply of spare parts in stockroom (specifies and requests purchase of components).
  • Performs all administrative duties including documenting maintenance and repair calls in SAP as well as completing required documentation and reports.
  • Proficient and compliant with ISO standards and practices.

EXPERIENCE AND QUALIFICATIONS:

  • Experience highly desirable : Robotic instrumentation (especially HPLC, Hamilton, Bravo, and Biomek FX), liquid handling instruments, and pneumatic instruments
  • Knowledge of GMP, ISO 9001, and 13485 processes
  • Experience with general handheld tools plus multimeters and other electronic test equipment.
  • Working knowledge of molecular biology, chemistry, and/or biology preferred.
  • Must be able to work effectively alone under minimal supervision and complete assigned work targets in a timely manner. 
  • Excellent organizational skills, including the ability to handle multiple  work tasks and priorities.
  • Excellent verbal and written communication skills and the ability to interpret and summarize scientific/technical results in a clear, concise, accurate manner.
  • Demonstrated ability to formulate and solve problems.
  • Must be flexible to work weekends and overtime during the week or swing shift. 
  • Minimum High School Diploma
  • Experience: 1-2 years repair experience (Field Service or In-House Service)

To apply for a position send your resume to Jobs@JGBBioPharma.com

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122) Health, Safety, and Environment (HSE) Manager – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) B131DM

DESCRIPTION:

  • Responsible for the administration of Health, Safety, and Environment (HSE) programs for design, construction and operational support of site pharmaceutical manufacturing facility. 
  • Plans, implements and coordinates HSE programs to reduce or eliminate occupational injuries and illnesses, and to prevent environmental impacts. 
  • Delivers training, identifies, evaluates and eliminates occupational hazards and ensures site compliance with governmental regulations and HSE Policies and Guidelines. 
  • Manages HSE details of large capital projects, and provides HSE support to ongoing site operations. 
  • Independently resolves a wide variety of issues of complex scope. 
  • Analyzes and evaluates process and operational hazards and mitigates risks. 
  • Contributes to the design of mechanical systems, and wastewater and air pollution abatement systems, and verifies system operation. 
  • Addresses questions and/or issues related to HSE regulatory and corporate requirements in support of project design and construction, process hazard analysis, containment and risk mitigation. 
  • Provides point of contact for regulatory agency visits and compliance investigations. 
  • Plans, develops and manages site procedures for adhering to local, state and federal HSE regulations.

EXPERIENCE AND QUALIFICATIONS:


  • Minimum of 7 years' experience in HSE administration. CIH or CSP certification desirable. 
  • Knowledge of OSHA, EPA and NFPA regulations and codes. 
  • Preferred safety training includes: 24-hour HAZWOPER, OSHA 10-hour General Industry, OSHA 10-hour Construction Industry, and Asbestos Hazard Emergency Response Act (AHERA), and Title 22 California Hazardous Waste Management, and First aid, CPR/AED. 
  • Familiarity with Facilities Engineering and construction Project Management is highly desirable. Examples: HVAC, RODI, Electrical systems, BMS/BAS. 
  • Ability to work with all levels of management. Lead and direct the work of others. 
  • Extensive experience and judgment to plan and accomplish goals. 
  • Strong written and oral communications skills. 
  • Ability to work in high stress environment, to perform multiple tasks, to make decisions and handle emergency situations
  • Professional Engineer or Master of Science degree in HSE-related field of study; or Bachelor Degree with equivalent work experience in pharmaceutical industry

To apply for a position send your resume to Jobs@JGBBioPharma.com

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123) Senior Biostatistician / Manager, Biostatistics – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) B111DK

DESCRIPTION:

  • Work with clinical development teams in the design and conduct of clinical studies and in the evaluation, interpretation and preparation of study results.
  • Provide sound experimental design and data analysis expertise.
  • Author the protocol statistical sections and generate statistical analysis plans and study randomization as needed.
  • Review and sign off on relevant study documents and data management deliverables.
  • Prepare and review mockup tables, figures and listings. Determine analysis and data presentation specifications for CRO programmers and statisticians.
  • Provide verification and QA reviews on final tables, figures and listings.
  • Perform analysis, interpret study results, and collaborate with medical and biostatistics staff to produce interim reports, final reports, and publications.
  • Represent the biostatistics and programming functions on project teams.
  • Work with biostatistics and clinical staff to define datasets and analyses for the integrated summary of safety and efficacy. Interpret results of integrated summary analyses and collaborate with medical and biostatistics staff to produce reports for the application to regulatory agencies.

EXPERIENCE AND QUALIFICATIONS:

  • Must possess a comprehensive and detailed understanding of statistical experimental designs and analyses, clinical trial requirements and statistical software packages such as SAS.
  • Understanding of regulatory guidelines that affect statistical deliverables.
  • Experience with the management and statistical analysis of data obtained from Phase I-III clinical trials or studies in support of U.S. PLAs/NDAs.
  • Experience with PLA/NDA submission a plus.
  • Strong interpersonal and effective communication (oral and written) skills
  • Minimum: Ph.D. in Biostatistics, Statistics or closely related discipline with >2 years’ experience, or a Master's Degree in Biostatistics, Statistics or closely related discipline with >4 years’ experience in the support of clinical studies in a pharmaceutical industry or clinical studies setting.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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124) Statistician – Contract (New Jersey) 3817

DESCRIPTION:

  • Work on the planning and implementation of statistical analyses for ISE and ISS in preparation of a NDA submission, based on existing clinical studies. This entails identifying and understanding existing clinical studies including databases, developing SAPs for ISE and ISS, directing programmers in the integration of clinical databases and generation of statistical analysis outputs, reviewing ISE and ISS documents. 
  • Occasional SAS programming to generate ad hoc analyses is expected.
  • Will serve as study statistician under the guidance of the statistical project lead, providing statistical support to all study related activities, including participating in Clinical Trial Team meetings, SAP development, IVRS specifications, CRF review, working with assigned programmer(s) to set up study database, take leadership role in data review related activities. 
  • Provide support to the planned activities, e.g., generation of open report, as appropriate, transmit blinded data to a 3rd party, 
  • May also coordinate certain randomization related activities with an IVRS vendor.

EXPERIENCE AND QUALIFICATIONS:

  • At least 5 years experiences with Pharmaceutical or Biotech companies.
  • Ph.D or Master in Statistics/Biostatistics or very closely related areas. 

To apply for a position send your resume to Jobs@JGBBioPharma.com

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125) Sr Project Manager Process Improvements & Analytics – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) GP113F

DESCRIPTION:

  • Will partner with clinical development functions and project teams to develop scalable, robust, and streamlined business processes that meet business needs and support achievement of goals and objectives.  
  • Supports development sciences functions by acting as a liaison between project teams, management, and technology management groups for process improvement initiatives and analytics.
  • Leads the development of optimized business processes, process improvements, and change initiatives that meet business needs and support achievement of development sciences goals and objectives
  • Partners projects teams and functions to identify process gaps and involved in defining actionable response strategies 
  • Partners with clinical project teams and business technology management to deliver business results focused on establishing and improving business processes that improve reliability, increase simplicity, and enable growth 
  • Oversees metrics reporting dashboard and associated metrics tools
  • Analyzes and interprets metrics data to provide business insights and answer key business questions that help the development sciences organization make data driven process improvement decisions
  • Coaches, motivates, and provides career and technical advice to business analysts 

EXPERIENCE AND QUALIFICATIONS:

  • Experience successfully applying business analytics and metrics to process improvement projects
  • Demonstrated project management skills with proven ability to oversee and/or manage multiple tasks to conclusion, on time, and without compromise to quality of work output
  • Cross-functional understanding of drug development processes 
  • Awareness of clinical systems including but not limited to CTMS, EDC, and IXRS
  • Experience working in a regulated environment 
  • Highly proficient with project management tools and processes (e. g. MS Project, Excel, PowerPoint, and Visio)
  • Experience with formal process improvement methodologies including Business Analysis, Balanced Scorecard, LEAN, and/or BPMN 
  • 7+ years related experience leading -functional teams in successful business process analysis, design, and optimization
  • BS/BA required with 12-15 years of related experience in pharma/biotech business/operations, 10-13 years with a Masters, 7 - 10 years with a PhD or 2+ Master’s
  • PMP or BPM Certification and/or certification in an established process improvement methodology preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

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126) Laboratory Technical Supervisor – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) Z138AG

DESCRIPTION:

  • Develop a nationally recognized CLIA reference laboratory.
  • Ensure compliance with state and federal regulatory agencies, including timely submission of proficiency testing.
  • Conduct inspection preparation and lead onsite inspections.
  • Act as a Quality Systems Manager and evaluate the policies, procedures, and processes as well as implement laboratory improvements.
  • Oversee laboratory Quality Assurance/Quality Compliance and conduct annual review.
  • Participate in review/approval of all relevant documents and procedures.
  • Ensure smooth operations of high complexity laboratory, including inventory control, results accessioning and reporting, and documentation of variances.
  • Achieve greatest level of test accuracy, timeliness and medical value for a growing patient base.
  • Documentation and implementation of remedial action whenever laboratory testing deviates from best practices.
  • Work with R&D to validate novel testing systems.
  • Develop new tests and maintain existing procedures, following NCCLS guidelines for SOPs.
  • Maintain patient and laboratory records consistent with state and federal regulations.
  • Oversee customer satisfaction and implement procedures for resolving complaints.
  • Evaluate, document, and ensure competency of all testing personnel consistent with state and federal guidelines, and high levels of team productivity and collegiality.
  • Develop laboratory budget to ensure efficient use of resources.
  • Understand and implement OSHA and CLIA requirements.

EXPERIENCE AND QUALIFICATIONS:

  • Excellent analytical and laboratory skills.
  • Experience with a broad array of assays including clinical chemistry, hematology, microbiology, and molecular diagnostics.
  • Experience managing clinical laboratory personnel.
  • Experience managing new laboratories, or sections of laboratories, consistent with best practices and lean/six-sigma principles is highly desirable.
  • Experience with preparing for and coordinating laboratory inspections by State and Federal agencies.
  • Desire to be part of a fast-paced, rapidly growing start-up company.
  • Proficiency with procedures to ensure analytic performance such as Westgard rules and Levey-Jennings analysis.
  • Proven ability to help scale clinical laboratories in a dynamic environment while maintaining excellence in performance at every level.
  • Graduation from an accredited CLS program.
  • Hold a current Clinical Laboratory Scientist license issued by the State of California.
  • At least 4 years of experience in high complexity testing with a proven track record of exceeding quality expectations.
  • Bachelor's degree in chemical, physical or biological science or medical technology from an accredited institution

To apply for a position send your resume to Jobs@JGBBioPharma.com

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127) Laboratory General Supervisor – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) BX138R

DESCRIPTION:

  • Develop a nationally recognized CLIA reference laboratory.
  • Ensure compliance with State and Federal regulatory agencies, including timely submission of proficiency testing.
  • Monitor patient testing and specimen acceptability to ensure accurate analytic performance.
  • Provide orientation and training to all testing personnel.
  • Management of accessioning, test performance and critical analysis of patient results reporting in collaboration with the laboratory director.
  • Coordinate send-out testing to reference laboratories.
  • Achieve greatest level of test accuracy, timeliness and medical value for a growing patient base.
  • Work with R&D to validate clinical diagnostic instrumentation.
  • Manage successful introduction of new tests to laboratory, and maintain existing procedures, following NCCLS guidelines for SOPs.
  • Oversee customer satisfaction and implement procedures for resolving complaints.
  • Ensure competency of all testing personnel and high levels of team productivity and collegiality.
  • Work with Technical Supervisor and Lab Director to develop laboratory budget to ensure efficient use of resources.
  • Understand and implement OSHA and CLIA requirements.

EXPERIENCE AND QUALIFICATIONS:

  • Experience working with a broad array of assays including clinical chemistry,
  • Desire to be part of a fast-paced, rapidly growing start-up company.
  • Hematology, Microbiology, and Molecular Diagnostics.
  • Experience managing clinical laboratory personnel.
  • Experience managing new laboratories, or sections of laboratories, consistent with best practices and lean/six-sigma principles is highly desirable.
  • Strong knowledge and experience with public health laboratory laws and regulations.
  • Proven ability to help scale clinical laboratories in a dynamic environment while maintaining excellence in performance at every level.
  • Graduation from accredited CLS program
  • Hold a current Clinical Laboratory Scientist license issued by the State of California
  • At least two years of experience in high complexity testing, with proven track record of exceeding quality expectations.
  • Bachelor's degree in chemical, physical or biological science or medical technology from an accredited institution.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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128) Clinical Microbiology Supervisor – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) JP138C

DESCRIPTION:

  • Develop a nationally recognized CLIA reference laboratory.
  • Ensure compliance with state and federal regulatory agencies, including timely submission of proficiency testing.
  • Conduct inspection preparation and lead onsite inspections.
  • Act as a Quality Systems Manager and evaluate the policies, procedures, and processes as well as implement laboratory improvements.
  • Oversee laboratory Quality Assurance/Quality Compliance and conduct annual review.
  • Participate in review/approval of all relevant documents and procedures.
  • Ensure smooth operations of high complexity laboratory, including inventory control, results accessioning and reporting, and documentation of variances.
  • Achieve greatest level of test accuracy, timeliness and medical value for a growing patient base.
  • Documentation and implementation of remedial action whenever laboratory testing deviates from best practices.
  • Work with R&D to validate novel testing systems.
  • Develop new tests and maintain existing procedures, following NCCLS guidelines for SOPs.
  • Maintain patient and laboratory records consistent with state and federal regulations.
  • Oversee customer satisfaction and implement procedures for resolving complaints.
  • Evaluate, document, and ensure competency of all testing personnel consistent with state and federal guidelines, and high levels of team productivity and collegiality.
  • Develop laboratory budget to ensure efficient use of resources.
  • Understand and implement OSHA and CLIA requirements.

EXPERIENCE AND QUALIFICATIONS:

  • Excellent analytical and laboratory skills.
  • Experience with microbiology; Manage the processing of infectious specimens, conduct testing, and report test results with constant attention to detail and excellence in quality.
  • Experience managing clinical laboratory personnel.
  • Experience managing new laboratories, or sections of laboratories, consistent with best practices and lean/six-sigma principles is highly desirable.
  • Experience with preparing for and coordinating laboratory inspections by State and Federal agencies.
  • Proficiency with procedures to ensure analytic performance such as Westgard rules and Levey-Jennings analysis.
  • Proven ability to help scale clinical laboratories in a dynamic environment while maintaining excellence in performance at every level.
  • Desire to be part of a fast-paced, rapidly growing start-up company.
  • Under the direction of technical and general supervisors, perform microbiological and/or DNA and RNA oriented laboratory procedures in accordance with standards established in the Clinical Laboratory Improvement Amendments (CLIA).
  • Resolve problems that may adversely affect test performance or reporting of test results
  • Assist with quality assurance and performance improvement activities.
  • Either a current California State Clinical Laboratory Scientist License (a Generalist or a limited license in Microbiology or Clinical Genetics Molecular Biology) or Public Health Microbiology (California) certification.
  • At least 4 years of experience in high complexity testing with a proven track record of exceeding quality expectations.
  • Bachelor's degree in Clinical Lab Sciences or related field.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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129) Regulatory Affairs Associate / Specialist – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) XR111F

DESCRIPTION:

  • Provide support and technical assistance to regulatory personnel reporting directly to either an Associate Director or Director of Regulatory Affairs.
  • Assist efforts associated with the preparation of regulatory documents or submissions for domestic or international projects.
  • Obtain documents/information for regulatory submissions from various functional areas and check for errors, legibility, and missing information.
  • Prepare routine regulatory correspondence, draft more complex correspondence, and assure submission to government agencies in support of investigational and marketed products is completed in accordance with supervisor’s requirements and guidance.
  • Support technical review of data or reports that will be incorporated into regulatory submissions to assure scientific accuracy, clarity and regulatory compliance.
  • Review clinical documents to ensure that data collection and submission meets global and regional accepted regulatory standards.
  • Participate in project teams and interacts and coordinate with personnel in other departments including Marketing, Legal, Clinical, Medical Writing, and Project Management as well as Regulatory Affairs counterparts outside the company as needed.
  • Maintain and disseminate current knowledge base of existing regulations, standards, or guidance documents and proactively seek and find information to help resolve questions related to assigned projects.
  • Assists in archiving regulatory documentation and maintaining related databases.

EXPERIENCE AND QUALIFICATIONS:

  • Has a positive approach to work projects and maintains constructive and positive interactions with colleagues.
  • Willingness and ability to learn and adapt quickly in a changing and fast paced work environment.
  • Good verbal and written communication skills and excellent comprehensive reading skills.
  • Exceptional planning, organizational, and prioritizing skills as well as attention to detail.
  • Proficiency in the use of MS Word, PowerPoint, and Excel; experience with Adobe Acrobat Professional a plus.
  • Position requires a minimum of 2 years relevant work experience in Regulatory Affairs. 

To apply for a position send your resume to Jobs@JGBBioPharma.com

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130) Cell Biologist – Contract (Southern California) 73R9202

DESCRIPTION:

  • The successful candidate will apply his/her in-depth knowledge in Molecular Biology to complete services projects or to develop new platform technologies. 
  • Will design, plan, and conduct laboratory experiments independently. 
  • Job duties will include leading Services projects. 
  • Training and guidance of other team members may be also required.
  • Solve problems associated with their project through application and integration of analytical skills, creativity, and judgment utilizing appropriate scientific principles.
  • Interact regularly with peers, subordinates, and functional peer groups, as well as customers and will present complex problems across functional areas. 
  • Write technical reports, develop protocols, and may give technical presentations to customers or at meetings.
  • All deliverables will impact business performance and operational efficiency.

EXPERIENCE AND QUALIFICATIONS:

  • Molecular Biology techniques and Stable Mammalian Cell Line Generation (Cell Engineering) is required. 
  • Hands–on training in qPCR, next generation sequencing, high throughput, and automation are desirable. 
  • The successful candidate should also have excellent organization and communication skills.
  • Recent Cell Culture Experience with various types of cells
  • Basic Molecular Biology Techniques
  • QPCR and Cloning
  • M.S. with 5 years of relevant experience, or PHd. with 1 year of relevant experience, in Molecular Biology or related discipline.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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131) Clinical Project Leader – Full Time (San Francisco/South Bay/Marin/Sonoma/Napa/Santa Rosa/Petaluma) W109FJ

DESCRIPTION:

  • Responsible for all aspects of project management and coordination of cross-functional projects initiated by medical clinical affairs. This includes the review of project proposals, budgets, and contracts, as well as tracking of all milestones, budgets, and timelines. 
  • Responsible and accountable for assuring that the project team under her or his leadership meets all deadlines and is also required to maintain a close effective working relationship with sponsors, customers, vendors, leadership, and stakeholders. 
  • Demonstrate strong project management skills with the ability to manage project budgets, deliverables, and timelines successfully 
  • Lead cross-functional project teams through successful completion of the project in a matrix team environment 
  • Effectively manage budgets and resources, reduce costs, maintain and accelerate timelines, as well as track and execute the project schedule. 
  • Drives the quality and completion of phase reviews, all milestones and deliverables.
  • Must be able to understand and solve technical issues at a detailed level 
  • Provides leadership to resolve action items 
  • Coordinate the development of project timelines and manage any changes, such as  future timeline changes that may result from changes in scope, delays in schedule or resource constraints
  • Evaluate potential risks and develop preventive and corrective action plans
  • Develop and finalize complete project plans with formalized project budgets, resources, milestones, and deliverable schedule 
  • Coordinates all project update meetings and present or lead presentations for project status reviews 
  • Facilitate and maintain records of all internal and external communications relevant to assigned projects 
  • Manage contractors, consultants, vendors, and suppliers 
  • Develop and tracks all project budgets, milestones and customer deliverables
  • Assist MCA leadership with justifications, budget estimates, resource requirements, and presentations to support new project proposals 
  • Prepare all project related reports on project performance for both internal and external stakeholders
  • Monitor and present project quality performance at periodic project review meetings 
  • Lead multiple projects and facilitate project activities to ensure project specifications and timelines are met.

EXPERIENCE AND QUALIFICATIONS:

  • Develop and manages an interdisciplinary project team throughout the life cycle of the project, including the evaluation phase 
  • Develop and review all project plans, schedule, proposals, budgets and contracts. 
  • Ensure all milestones are met, if not, take appropriate corrective actions and notify stakeholders 
  • Must be knowledgeable in healthcare 
  • Must be able to prioritize multiple, competing tasks with excellent organizational and communication skills. 
  • Require the ability of independent decision making based upon current factors related to specifics of each project. 
  • Use leadership skills to ensure that cross-functional resources are assigned and held accountable for task and outcome completion. 
  • Have demonstrated track record of leading within complex organizations requiring strong influence and people management skills. 
  • Establish communication plans for projects and ensure adherence to the plans and maintain appropriate communication to all project members and stakeholders.
  • Manage risk assessment and mitigation process for assigned projects.
  • Ensure adherence to established project management methodologies and best practices.
  • Excellent presentation skills
  • 3-5 years of project management experience in healthcare industry with a proven track record managing complex projects.
  • Proven knowledge of project management methodologies
  • Proven organizational and planning skills
  • Bachelor’s Degree in Life Science, Healthcare or Nursing 
  • Preferred Masters or Project Management Training 
  • Preferred working experience with dialysis or renal disease.  Experience with project management tools and best practices

To apply for a position send your resume to Jobs@JGBBioPharma.com

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132) Clinical Project Leader – Full Time (San Francisco/South Bay/Marin/Sonoma/Napa/Santa Rosa/Petaluma) W109FJ

DESCRIPTION:

  • Responsible for all aspects of project management and coordination of cross-functional projects initiated by medical clinical affairs. This includes the review of project proposals, budgets, and contracts, as well as tracking of all milestones, budgets, and timelines. 
  • Responsible and accountable for assuring that the project team under her or his leadership meets all deadlines and is also required to maintain a close effective working relationship with sponsors, customers, vendors, leadership, and stakeholders. 
  • Demonstrate strong project management skills with the ability to manage project budgets, deliverables, and timelines successfully 
  • Lead cross-functional project teams through successful completion of the project in a matrix team environment 
  • Effectively manage budgets and resources, reduce costs, maintain and accelerate timelines, as well as track and execute the project schedule. 
  • Drives the quality and completion of phase reviews, all milestones and deliverables.
  • Must be able to understand and solve technical issues at a detailed level 
  • Provides leadership to resolve action items 
  • Coordinate the development of project timelines and manage any changes, such as  future timeline changes that may result from changes in scope, delays in schedule or resource constraints
  • Evaluate potential risks and develop preventive and corrective action plans
  • Develop and finalize complete project plans with formalized project budgets, resources, milestones, and deliverable schedule 
  • Coordinates all project update meetings and present or lead presentations for project status reviews 
  • Facilitate and maintain records of all internal and external communications relevant to assigned projects 
  • Manage contractors, consultants, vendors, and suppliers 
  • Develop and tracks all project budgets, milestones and customer deliverables
  • Assist MCA leadership with justifications, budget estimates, resource requirements, and presentations to support new project proposals 
  • Prepare all project related reports on project performance for both internal and external stakeholders
  • Monitor and present project quality performance at periodic project review meetings 
  • Lead multiple projects and facilitate project activities to ensure project specifications and timelines are met.

EXPERIENCE AND QUALIFICATIONS:

  • Develop and manages an interdisciplinary project team throughout the life cycle of the project, including the evaluation phase 
  • Develop and review all project plans, schedule, proposals, budgets and contracts. 
  • Ensure all milestones are met, if not, take appropriate corrective actions and notify stakeholders 
  • Must be knowledgeable in healthcare 
  • Must be able to prioritize multiple, competing tasks with excellent organizational and communication skills. 
  • Require the ability of independent decision making based upon current factors related to specifics of each project. 
  • Use leadership skills to ensure that cross-functional resources are assigned and held accountable for task and outcome completion. 
  • Have demonstrated track record of leading within complex organizations requiring strong influence and people management skills. 
  • Establish communication plans for projects and ensure adherence to the plans and maintain appropriate communication to all project members and stakeholders.
  • Manage risk assessment and mitigation process for assigned projects.
  • Ensure adherence to established project management methodologies and best practices.
  • Excellent presentation skills
  • 3-5 years of project management experience in healthcare industry with a proven track record managing complex projects.
  • Proven knowledge of project management methodologies
  • Proven organizational and planning skills
  • Bachelor’s Degree in Life Science, Healthcare or Nursing 
  • Preferred Masters or Project Management Training 
  • Preferred working experience with dialysis or renal disease.  Experience with project management tools and best practices

To apply for a position send your resume to Jobs@JGBBioPharma.com

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133) Clinical Research Associate II – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) VF132D

DESCRIPTION:

Responsible for implementing and monitoring clinical trials and expands experience in clinical trial and vendor management procedures.  Works closely with study coordinators and investigators to ensure compliance with protocol and overall clinical objectives.  Develops independence in performing routine work and develops leadership skills.  Identifies projects/tasks and works with Clinical Trial Manager to complete.  Develops ability to organize, manage and set priorities for multiple tasks.  Demonstrates ability to carry out all CRA I functions with minimal supervision.  In collaboration with manager and/or Lead CRA, maintains consistent CRF data quality and discrepancy interpretation across sites.  Uses an established understanding of the disease, molecule and indication.  

Responsibilities:
  • Conducts site visits (pre-study, initiation, interim and close-out visits) to ensure protocol compliance, accurate and thorough data collection, and appropriate study conduct
  • Co-monitors with more junior CRAs to assist manager/Lead CRA with on-site monitoring and study visit training, as needed
  • Assists in CRF design and CRF guidelines
  • Develops study tools and guidelines to be utilized by study sites
  • Assists in the process used to evaluate and select potential investigators and sites
  • Prepares monitoring reports per SOPs
  • Interacts with investigators and study coordinators through frequent communication (written and verbal) and maintains effective management of study issues and assigned sites
  • Presents at Investigator/Study Coordinator meetings and represents company in the technology booth at scientific meetings, as necessary
  • Understands study timelines and manages sites to meet timelines
  • Collaborates with team to maintain consistent CRF data quality and discrepancy resolution across sites
  • Proactively identifies and works to resolve enrollment and data completion issues
  • Performs manual, in-house review of CRF data in clinical database for completeness and accuracy
  • Reviews site’s informed consents against the consent template for presence of all GCP requirements and protocol specific information.  Reviews the consent for accuracy and ensures that the consent is written in language that subjects will understand
  • Develops basic skills in writing informed consent templates, protocol and other documents. Applies knowledge of regulatory requirements/SOPs to documents
  • Coordinates and reviews regulatory documents from study sites; ensures completeness and accuracy
  • Ensures study records are auditable both at investigational sites and in-house
  • Responsible for tracking IND Safety Reports for assigned sites
  • Initiates drug/device shipments and ensures that drug supplies are adequate for assigned studies
  • Assists manager/Lead CRA with the investigator contract, budget, and payment process including legal language and document structure as it impacts assigned studies
  • Responsible for initiating and tracking quarterly site payments
  • Communicates status of trial to manager and team
  • Responsible for coordinating and leading various functional area projects and tasks
  • Develops basic skills in functional area team leadership
  • Partners with team members and other functional areas such as Regulatory, QA, Legal, Biometrics

EXPERIENCE AND QUALIFICATIONS:

  • Good verbal and written communication skills are required.  
  • Attention to detail and organizational skills
  • Working knowledge of GCP and FDA regulations
  • Proficiency in MS Word, Excel and PowerPoint
  • 2+ years of CRA experience in an industry setting, or four years of pharmaceutical/health care field experience including 1 year previous experience as a CRA.
  • Experience in clinical research at either a hospital or pharmaceutical/biotech company
  • BS/BA degree in a life science, RN, or related field

To apply for a position send your resume to Jobs@JGBBioPharma.com

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134) Analytical Chemist – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) Z122EJ

DESCRIPTION:

  • The perfect candidate is detail oriented and fluent with concentration/dilution equations, RP-HPLC, and Waters Empower Software. 
  • Create standard curves with accuracy and precision; modify gradients to enhance performance.  
  • Approximately 75% of time will be spent in the laboratory.
  • Pre-validation method development
  • HPLC and UHPLC (C-18 RP-HPLC)
  • Size Exclusion (HPSEC)
  • Purity assays
  • Potency assays
  • Ultraviolet spectroscopy assay
  • Buffer preparations
  • Formulation stability study time points.
  • Ordering lab consumables.
  • Maintenance of Instruments / Calibration Documentation.
  • Formulation experiments
  • Aerosol test methods.

EXPERIENCE AND QUALIFICATIONS:

  • Experience with Waters Empower Software is mandatory. 
  • Experience with RP-HPLC is mandatory
  • Biologics (protein) experience strongly preferred.
  • Solid understanding of pH and buffer systems is required.
  • QC background is a plus. 
  • GMP experience is required.
  • Must have excellent attention to detail and laboratory documentation skills
  • Flexibility/ experience in a start-up environment
  • Ability to work independently
  • BS/MS in chemistry or related life science with 5+ years’ experience or PhD with the lab skills but less experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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135) Sr QC Stability Associate / Manager – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) BL122T

DESCRIPTION:

  • Oversee the CMO/CRO stability program
  • Propose required stability protocols
  • Plan and execute analytical method transfers
  • Collaborate with contract labs to set up stability studies in compliance with FDA / ICH guidance.
  • Ensure that samples were properly tested and OOS investigations are properly conducted in a timely fashion.
  • Perform investigational stability studies as needed in house.
  • Perform data analysis/trending and write stability reports/CMC sections to support regulatory filings. 
  • Oversee the extractable/leachable program
  • Collaborate together with contract labs to establish the strategy on the program.
  • Coordinate in-house or with the contract labs to develop the analytical methods as needed.
  • Perform or evaluate method qualification/validation/transfer as needed.
  • Ensure that L/E testing is executed properly and raw data is analyzed.
  • Write reports/CMC sections as needed to support regulatory filings. 
  • Collaborate with Pharmaceutics and other departments for analytical development efforts.
  • Refine and review the analytical HPLC stability indicating methods from CMO.
  • Aerosol test methods and device qualification/validation by working with contract labs or the in-house team.
  • Provide input to establish quality aspects of R&D analytical lab 
  • Take responsibility for equipment qualification/PM/calibration.
  • Author SOPs as needed and provide analytical support to investigations on QC aspects of the product.

EXPERIENCE AND QUALIFICATIONS:

  • Must have good knowledge and experience with general laboratory techniques, experience with data review and good general chromatography knowledge.
  • Must have good technical writing skills.
  • Must have good knowledge and understanding of GMP guidelines.
  • Management of CROs and direct report experience a plus.
  • Strong organizational skills
  • Experience in a start-up environment; Flexibility
  • Biologics and / or aerosol drug and/or medical device experience are desirable
  • Experience with device extractables, Rabbit potency test, and microbial testing laboratory data desirable
  • Experience with bottle containers or glass injection vials a plus
  • Mandarin written and verbal fluency is desirable
  • BS or higher in chemistry, biochemistry or related field or equivalent
  • 6 or more years pharmaceutical laboratory experience in a GMP environment

To apply for a position send your resume to Jobs@JGBBioPharma.com

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136) Sr. Project Manager / Associate Director, Oncology – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) P113FX

DESCRIPTION:

  • Responsible for the execution of high quality project management to ensure the achievement of clinical development goals consistent with the product development objectives. 
  • The DPM manager will report into the Assoc. Director/Director and will be responsible for providing project management expertise to cross-functional development sciences project teams. 
  • Responsibilities and deliverables include project plans, timelines, budgets, and high quality team performance.
  • Develop and manage project plans and timelines for assigned studies in accordance with project goals
  • Lead clinical study teams throughout the study planning, conduct, data management, and close out phases.
  • Manage the monthly budgeting process, including forecasting and variance analysis.
  • Ensure high quality team performance by providing problem solving and decision making guidance to teams.
  • Develop and maintain strong, collaborative relationships with key stakeholders and organization.
  • Serve as a lead point of contact or manager of vendors and collaborators.
  • Contribute to the implementation of new project management processes and policies to advance growth and development of the DPM function.

EXPERIENCE AND QUALIFICATIONS:


  • Project Management, organization and planning, problem solving, decision making, communication and influence, teamwork and collaboration
  • Extensive knowledge of overall drug development process relevant to pharmaceutical/biotech organizations and roles for the various functional areas within clinical development.
  • Strong financial acumen; capable of planning and providing oversight of project budgets budget.
  • Strong timeline development and management experience; MS Project experience preferred.
  • Excellent oral, written, interpersonal, and organizational skills.
  • Attention to detail.
  • Demonstrated excellence in managing multiple projects in different clinical phases (I–IV).
  • Knowledge of Good Clinical Practices (GCP) and application to the conduct of Oncology global clinical studies.
  • 5-8 years experience in a Biotech or Pharmaceutical/CRO organization of which 3-5 years have been spent in project management or program management in Oncology drug/diagnostic development
  • A Bachelor of Science required. 
  • Masters or comparable experience in Oncology drug/diagnostic development or the Oncology scientific/clinical field highly desired. 
  • Certification or professional training in project management would be a plus

To apply for a position send your resume to Jobs@JGBBioPharma.com

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137) Associate Director / Director Regulatory Affairs – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) RF133J

DESCRIPTION:

  • Reporting to the Senior Vice President of Regulatory and Compliance, the Associate Director/Director of Regulatory Affairs is responsible for leading activities of Regulatory Affairs with emphasis on global regulatory strategy and the preparation, review and submission of documents to FDA and other regulatory authorities
  • Provides current regulatory intelligence and formulates regulatory strategies.
  • Oversees implementation of regulatory strategy and activities needed to secure approval of new drugs.
  • Oversees coordination, preparation and timely submission of regulatory documents.
  • Maintains current knowledge and expertise of FDA/EMA regulations and ICH guidelines.
  • Provides regulatory advice to other functional areas.
  • Serves as a principal interface with reviewers from FDA and other health authorities
  • Identifies perceived gaps in product development plans that may pose regulatory issues
  • Participates in regulatory due diligence activities.
  • Develops and maintains relationships with external vendors and regulatory health authorities.
  • Coordinates preparation of responses to queries from regulatory authorities.
  • Coordinates activities pertaining to meetings and conferences with FDA, EMEA, and other regulatory authorities
  • Maintains relationships and collaborates with partners to improve effectiveness in regulatory strategies.
  • Mentors department personnel and updates appropriate departments on the current regulatory environment.
  • Supervises employees, consultants/contractors in Regulatory Affairs
  • Optimizes employee performance by developing employees and promoting career growth.
  • Develops and implements regulatory operating guidelines and common work practices/strategies within the team.

EXPERIENCE AND QUALIFICATIONS:

  • Extensive experience in drug development and approval process (INDs, NDAs, MAAs) across all phases of development.
  • Demonstrated ability to interpret and stay current with FDA and other regulatory agency regulations and guidelines.
  • Experience with eCTD requirements and electronic submissions
  • Demonstrated knowledge of the regulatory requirements in the design and conduct of clinical trials, including preparation of regulatory submissions.
  • Demonstrated knowledge of regulatory aspects of Chemistry, Manufacturing and Controls and quality assurance, is a very strong plus.
  • International experience is desired
  • Orphan drug experience is a plus
  • Experience with labeling requirements is a plus
  • Demonstrated management expertise, including leadership and development of employees.
  • Ability to work effectively across teams, functions and with outside partners.
  • Excellent oral and written communication skills.
  • Excellent organizational skills and attention to detail.
  • 10+ years of drug development and regulatory affairs experience in the Biotech/ Pharmaceutical industry.
  • Advanced degree MD, Pharm.D. or Ph.D. preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

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138) Regulatory Operations Associate – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) A111JP

DESCRIPTION:

  • Reports to the Associate Director of Regulatory Operations. 
  • Responsible for the day-to-day support of paper and electronic submissions to Global Regulatory Health Authorities (i.e., FDA, Health Canada, EMA, China SFDA, etc.).
  • Will play a key role in the development of regulatory infrastructure (databases, systems, and tools) used to support the day-to-day department activities. This role will be integral in the roll out and management of eCTD submissions, including the development of its processes.
  • Responsible for the oversight and administration of the Regulatory Archiving Inbox.
  • Supports daily submission activity, including (but not limited to) the assembly of Regulatory Submissions to US FDA in both paper and electronic eCTD format.
  • Supports ex-US submission activity to global health authorities, including (but not limited to) the preparation, formatting, and QC of documents being submitted global health authorities in the Asian and EU regions through CROs and Partners.
  • Review and format document according to Regulatory Operations standards. 
  • Troubleshoot and resolve complex document issues.
  • Gather information in support regulatory submissions for drugs products.
  • Maintain and fix Regulatory System and Database issues (e.g., SharePoint and MS Access).
  • Responsible for the Regulatory Archiving Inbox. Duties include archiving all Health Authority communications received for global health authorities either directly or from affiliates. 
  • Plays an integral role in the QC of Regulatory Documents and Submissions.
  • Provides support and training on custom authoring and formatting tool.
  • Contributes toward the development and implementation of department-wide SOPs, policies and/or work processes to streamline all submission activities and standardize interactions with other departments
  • Assists in typing, formatting, editing, proofing, creating and manipulating complex tables, converting text and graphics, scanning, bookmarking and hyper linking.
  • Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval
  • Provides oversight and participates in the maintenance of the submissions archive room and electronic submission repositories

EXPERIENCE AND QUALIFICATIONS:

  • Strong technical skills, including knowledge of IT systems and document management concepts.
  • Proficiency in relevant systems and software, including eCTD software, Document Management Systems, MS Access, SharePoint, Microsoft Office, and Adobe Acrobat
  • Familiarity with FDA requirements for regulatory submissions (such as eCTD)
  • Outstanding interpersonal, planning and organizational skills
  • Have a passion for quality and an impeccable detail orientation
  • Excellent writing, verbal communication skills and proven successful management abilities
  • Ability to work under deadline pressure / rapidly shifting priorities and manage multiple projects
  • 1-2 or more years of pharmaceutical industry experience
  • 1-2 or more years in regulatory affairs, with demonstrated ability to interact successfully with team members and health authorities where appropriate
  • Bachelor's degree and/or equivalent work experience

To apply for a position send your resume to Jobs@JGBBioPharma.com

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139) Senior Manager Development Sciences Operations Process Improvements and Analytics – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) RG113T

DESCRIPTION:

  • Supports clinical development teams and management with insights, business intelligence, and performance metrics for effective decision making and process improvements. 
  • Supports development sciences functions by acting as a liaison between project teams, management, and technology management groups for process improvement initiatives and analytics. 
  • Leads continuous improvement projects that  support achievement of development sciences goals.
  • Oversees all aspects of selection, building, deployment, and implementation of a metrics dashboard and associated metrics tools
  • Design and oversee data analysis activities providing business context and industry insights to help organization make data driven process improvement decisions
  • Provide interpretation of KPIs, metrics, and analytics to answer key business questions
  • Support study team activities, operating reviews, and management requests through the delivery of information and performance metrics
  • Plan and oversee metric data analysis activities providing business context and industry insights to help the organization make data driven process improvements
  • Lead cross-functional teams to develop and implement clinical development process improvement initiative
  • Drive development of innovative solutions and process improvements through benchmarking and performance management
  • Coach, motivate, and provide career and technical advice to direct reports and others in department

EXPERIENCE AND QUALIFICATIONS:

  • Experience with biotech or pharmaceutical industry benchmarking and developing metrics within a performance management framework
  • Experience and proven track record with process improvement including process mapping within a formalized methodology (i.e. six sigma, LEAN, etc.)
  • Demonstrated project management skills; proven ability to manage multiple tasks to conclusion, on time, and without compromise to quality of work output
  • Cross-functional understanding of drug development processes
  • Experience presenting data and findings to executives and other leadership teams
  • Previous management experience of direct reports
  • Demonstrated ability leading cross-functional teams in the development of complex processes and metrics
  • Strong facilitation and writing skills, and effective problem-solving and interpersonal skills.
  • High degree of customer sensitivity and acumen.
  • Knowledge of IT systems and databases
  • Excellent organizational skills and attention to detail.
  • Highly proficient with project management tools and processes (e. g. MS Project, PowerPoint, Visio), as well as word processing, presentation and spreadsheet applications.
  • Experience with formal methodologies including Business Analysis, PMP, Balanced Scorecard, LEAN, BPMN, Data Analysis
  • BA/BS/BSc or RN with 9 years of experiences in the sciences, technology, or medically related field including 6 years of biopharmaceutical clinical development (clinical research of clinical operations experience obtained at a biotech, pharmaceutical, CRO, or industry supplier company) and 5 years of analytics experience working with a variety of data sources including data from clinical trial systems supporting study design, planning, startup, conduct and closeout
  • PMP Certification and/or certification in an established process improvement methodology preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

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140) Senior Manager Project and Clinical Process Analytics – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) RG113T

DESCRIPTION:

  • Supports clinical development teams and management with insights, business intelligence, and performance metrics for effective decision making and process improvements. 
  • Supports development sciences functions by acting as a liaison between project teams, management, and technology management groups for process improvement initiatives and analytics. 
  • Leads continuous improvement projects that  support achievement of development sciences goals.
  • Oversees all aspects of selection, building, deployment, and implementation of a metrics dashboard and associated metrics tools
  • Design and oversee data analysis activities providing business context and industry insights to help organization make data driven process improvement decisions
  • Provide interpretation of KPIs, metrics, and analytics to answer key business questions
  • Support study team activities, operating reviews, and management requests through the delivery of information and performance metrics
  • Plan and oversee metric data analysis activities providing business context and industry insights to help the organization make data driven process improvements
  • Lead cross-functional teams to develop and implement clinical development process improvement initiative
  • Drive development of innovative solutions and process improvements through benchmarking and performance management
  • Coach, motivate, and provide career and technical advice to direct reports and others in department

EXPERIENCE AND QUALIFICATIONS:

  • Experience with biotech or pharmaceutical industry benchmarking and developing metrics within a performance management framework
  • Experience and proven track record with process improvement including process mapping within a formalized methodology (i.e. six sigma, LEAN, etc.)
  • Demonstrated project management skills; proven ability to manage multiple tasks to conclusion, on time, and without compromise to quality of work output
  • Cross-functional understanding of drug development processes
  • Experience presenting data and findings to executives and other leadership teams
  • Previous management experience of direct reports
  • Demonstrated ability leading cross-functional teams in the development of complex processes and metrics
  • Strong facilitation and writing skills, and effective problem-solving and interpersonal skills.
  • High degree of customer sensitivity and acumen.
  • Knowledge of IT systems and databases
  • Excellent organizational skills and attention to detail.
  • Highly proficient with project management tools and processes (e. g. MS Project, PowerPoint, Visio), as well as word processing, presentation and spreadsheet applications.
  • Experience with formal methodologies including Business Analysis, PMP, Balanced Scorecard, LEAN, BPMN, Data Analysis
  • BA/BS/BSc or RN with 9 years of experiences in the sciences, technology, or medically related field including 6 years of biopharmaceutical clinical development (clinical research of clinical operations experience obtained at a biotech, pharmaceutical, CRO, or industry supplier company) and 5 years of analytics experience working with a variety of data sources including data from clinical trial systems supporting study design, planning, startup, conduct and closeout
  • PMP Certification and/or certification in an established process improvement methodology preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

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141) Senior Project Manager / Associate Director – Contract to Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) G137AP

DESCRIPTION:


  • Assembling/ refining the Microsoft timeline and plan for a NDA submission
  • Tracking inputs needed for NDA submission and working with team members and regulatory to provide required sections in a timely fashion
  • Calendaring meetings, generating agendas and minutes, distributing materials for review with deadlines, tracking review progress and decisions, coordinating and documenting approvals, and maintaining a repository of approved materials.
  • Closely and transparently managing the critical path of the project.
  • Collaborating with cross-functional stakeholders to identify strategic and operational risks to timelines and deliverables to create appropriate mitigation and contingency plans.

EXPERIENCE AND QUALIFICATIONS:


  • Demonstrated judgment in selecting methods and techniques for obtaining solutions.
  • Strong influencing skills:  proven ability to get things done without formal authority.
  • Ability to work effectively with cross-functional teams.
  • Late stage drug development and Regulatory (NDA) submission experience required.
  • Oncology and commercial launch experience is a plus.
  • Highly proficient in MS Office Suite (Excel, MS Project, PowerPoint).
  • Proven Ability to work independently.
  • Bachelor’s Degree required.  Scientific degree preferred.
  • Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders.
  • A minimum of 5 years of Project Management experience supporting cross functional drug development teams in the pharmaceutical/biotech industry is required

To apply for a position send your resume to Jobs@JGBBioPharma.com

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142) Interaction Designer – Contract (Southern California) 73R5715

DESCRIPTION:

  • UX deliverables include concept development, wire framing, user flows, visual design mock-ups and rapid prototyping / demos; including production ready assets, icons, logos, mood boards and presentations
  • UX design leadership, expertise, and support to define approach to programs that accommodate constraints (e.g. scope, timelines & cost etc.) while delivering the best user experience
  • Ability to understand goals of a users (both personal and objective) in order to solve meaning problems in the best way possible
  • Leverage behavior based research to create and use tools such as personas, work models, and interactive prototypes in an iterative and collaborative manner.
  • Capable of rendering high fidelity page design layouts and iconography
  • Establish global standards, style guides, guidelines as well as graphical assets including icon library and screen design templates to ensure consistency across all software and embedded apps
  • Collaborate and develop concept explorations throughout entire project lifecycle, facilitating and driving UX solutions
  • Execute UX designs in alignment with overarching business goals aligned with brand language standards
  • Articulate and track project milestones, deliverables and risks with UX programs, in addition, communicate progress, short-term and long-term tasks/deliverables, issues and accomplishments
  • Educate the broader organization with in-depth knowledge and examples of why interface design and information architecture is key to delivering great user experience
  • Demonstrate ability to lead and influence across a broad, dispersed global team
  • Contribute to the knowledge base around user-centered experience design through the products developed and best practice research
  • Be on-point with external vendor communication directly related to UX visual design support
  • Expert facilitation, brainstorming and collaboration skills with expert user experience orientation and exceptional people skills
  • Strong analytical skills, and proven creativity
  • Proficient with diverse writing, presentation, project management software

EXPERIENCE AND QUALIFICATIONS:

  • 12+ years experience in a software application and graphic user interface design role / function
  • Knowledge and practice of UX industry best practices including User-Centered Design and HFE best practices
  • Must have an expert understanding of current version of Photoshop and Illustrator. Knowledge of Fireworks, CSS, Dreamweaver, GoLive, After Effects, 3d Software, iWorks and Microsoft Office and other interaction design SW are a plus
  • Experience designing robust Flash and HTML web sites and/or mobile apps with highly intuitive UI and navigation schemes
  • Expert visual literacy and understanding of typography, illustration, color theory, wire framing, and photo manipulation
  • Must have expert verbal communication skills, including the ability to speak effectively before staff or other internal groups
  • An expert portfolio of solid web, mobile and multi-media are required. Broadcast, print, identity, packaging, storyboard sketches are a plus
  • Bachelors Degree in Design, Computer Science, Human Factors Engineering or equivalent work experience and expertise in Visual Design and Information Architecture

To apply for a position send your resume to Jobs@JGBBioPharma.com

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143) Medical Director, Clinical Development – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) GF129B

DESCRIPTION:

  • Hands-on participation in the clinical program and trial development process - conceive and execute clinical strategy and provides clinical expertise for the research and development project 
  • Serve as the Medical Monitor for clinical trials (Phase 1 and Phase 2) 
  • Lead preparation of clinical sections of all relevant documents and regulatory filings (Investigator brochure, IND, study reports, etc)
  • Interact with key opinion leaders to assure implementation of latest clinical thinking and guidelines into the clinical development plan 
  • Serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contract resources 
  • Interact in collaborations with strategic partners 
  • Represent the company at scientific, commercial and financial community meetings and presentations, as well as other public relations opportunities 
  • Responsible for clinical development plan in highly competitive therapeutic areas 
  • Provide input/review study start up documentation, e.g. CRF design, source data verification plans based on protocol specifications 
  • Attend and provide science support for investigator and consultant meetings and other study implementation workshops 
  • Manage studies and provide expertise on clinical and medical issues to other colleagues and study site staff  
  • Review study data 
  • Evaluate Serious Adverse Events (SAEs) and provide input on safety reports 
  • Author clinical sections for final study reports 
  • Participate in preparation for submission activities as appropriate 
  • Assists in the development of publications, abstracts, and presentations 

EXPERIENCE AND QUALIFICATIONS:

  • Experience in small molecule clinical development preferred 
  • Ability to direct strategic interactions and partnerships with outside collaborators, such as academic research groups, corporate partners, CROs and other vendors
  • Reputation as a leader in the field with sustained performance and accomplishments as evidenced by quantity and quality of publications, patents, regulatory filings and/or other technical documents
  • Proven abilities in the review and interpretation of complex scientific data in order to form appropriate clinical opinions 
  • Strong interpersonal, team and collaborative skills, ability to function and influence effectively in a broad multidisciplinary group; consistently looking for win-win solutions to problems 
  • Passion for continued learning and mentoring 
  • Results-oriented self-driven and motivated individual who enjoys the immediacy of personal effort and impact 
  • MD with experience in the pharma/biotech industry conducting, interpreting human clinical studies with 5 or more years of experience 
  • Board eligibility/certification in hematology and/or oncology preferred 
  • Knowledge of or experience in hematologic malignancies strongly preferred 

To apply for a position send your resume to Jobs@JGBBioPharma.com

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144) Clinical Assistant – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) M111YV

DESCRIPTION:

  • Provide support and assistance to the clinical operations team in the implementation and management of clinical trials.
  • Set-up and maintain all study and clinical operations files for assigned clinical studies
  • Route, track, and receive all essential clinical documents and business with CROs, other departments, sites, partnership collaborations, and vendors  
  • Maintain study documents, binders, manuals, and supplies to ensure adequate inventory for clinical operations and clinical sites 
  • Assist in the set-up and coordination of clinical activities and meetings, prepare meeting minutes as requested  
  • Maintain databases and tracking systems and review reports from various data sources (including the Clinical Trial Management System).  
  • Maintain quality records and documentation for ensuring compliance with FDA regulations, ICH guidelines, and company SOPs and guidelines  
  • Assists with preparing for meetings such as investigator meetings, partner meetings, scientific meetings as requested  
  • Works with supervisor and clinical operations team to achieve corporate goals and departmental goals within the expected time frames  
  • Assisting other departments, e.g. QA and/or RA, as needed with the Document Control System and regulatory submissions

EXPERIENCE AND QUALIFICATIONS:

  • Strong computer skills (MS Office) including the ability to create tracking systems and spread sheets  
  • Good working knowledge of FDA & ICH/GCP regulations and guidelines  
  • Strong analytical and assessment skills; good solving problems  
  • Organized and flexible team player that is able to asses priorities, multi-task, and meet deadlines  
  • Takes direction well and is able to understand and complete tasks under minimal supervision and with a high degree of accuracy and quality  
  • Ability to work under pressure and proactively identify issues with a solutions-oriented approach
  • Bachelor’s degree  
  • 1 year of clinical research experience working at a clinical trial site, CRO

To apply for a position send your resume to Jobs@JGBBioPharma.com

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145) Senior Director / Director, Program Management – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) CY127F

DESCRIPTION:

Summary

Will oversee, organize and shape commercial and development programs to ensure that all milestone requirements are met per agreed upon project specifications, costs, resources and on time and working with team, offers creative solutions to mitigate risk and solve problems. Sets agenda and chairs recurring program management cross functional meetings, ensures effective cross functional communications are achieved with all team members. The Project Manager highlights risks, timeline delays and other issues to Senior Management.  Previous commercial product experience required, global experience preferred.


Responsibilities
  • Oversees program plan development, tracks and updates milestones and key activity streams that enable the cross-functional project teams to meet objectives
  • With team members and in accordance with corporate objectives, facilitate the setting of program objectives, key milestones and scope
  • Develops detailed project plans including milestones, timelines, develop proactive corrective action plans for resolution of problems or issues, anticipation of problems, and facilitation of scope management
  • Leads team meetings and ensures that clear actions and decisions are documented, communicated and committed to, enabling timeline achievement
  • Minimizes extraneous information and reduces non-essential communications 
  • Act as central point of contact for program management 
  • Anticipates project challenges and risk scenarios and prepares/leads and executes proactive mitigation strategies 
  • Utilizes project metrics and ensures personnel understand status and critical attention areas
  • Builds strong working relationships across departments, with key stakeholders, and Senior Management to ensure transparency and to facilitate communication.

EXPERIENCE AND QUALIFICATIONS:

  • Prior international and global experience preferred 
  • Direct experience managing development timelines and budgets from development through commercial launch. Demonstrated competency in managing multiple projects in different phases, and in different regions.  
  • Ability to work independently as well as part of a multi-functional program team  
  • Must be willing and able to travel on a periodic basis, up to 20%
  • Must be well versed in project management tools and must possess knowledge of related disciplines
  • Computer proficiency in Microsoft Word, MS Project, Excel, and Outlook
  • Bachelor’s degree in a biological science is preferred
  • 5+ years’ of pharmaceutical industry experience with at least 3 years of hands-on experience as a program manager responsible for program management.  
  • Prior commercial experience required

To apply for a position send your resume to Jobs@JGBBioPharma.com

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146) Director Clinical Operations – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) A125XL

DESCRIPTION:

  • Line management of CT Manager(s),Clinical Trial Associates (CTAs) , and other functional members as needed. One or more direct reports to start.
  • Provide leadership, operational expertise and guidance as a point of escalation for clinical operations coordination issues.
  • Performance management: Tasks include and are not limited to: setting/communicating performance standards; performing ongoing performance management activities including individual goal setting/periodic performance assessments/timely performance feedback/coaching/development planning; and tracking and monitoring attendance/timesheets/expense reports. Identify and address performance issues and training needs.
  • Partner with Medical Director to ensure consistent high quality of work while timelines are met
  • Strategically assess metrics and ensure implementation of appropriate measures as necessary to support project or program targets / deliverables.
  • Lead strategic planning and process development/ implementation for the function(s), tracking timelines to remain on schedule, and developing contingency strategies, if needed.
  • Ensure GCP/ICH and Standard Operating Procedures (SOP) compliance and implementation across clinical trials.
  • Lead/participate in meetings to plan and implement cross-functional operational activities to increase quality, productivity, and efficiency within Clinical Operations.
  • Ensure effective and efficient collaboration between internal customers and external providers (CROs). 
  • Liaise with internal (Study Management, site contracting, Central Services) and external (investigational sites and vendors) partners/stakeholders to assess functional team processes/performance and opportunities for development/enhancement.
  • Maintain clear lines of communication with functional managers to ensure high quality deliverables are met.
  • Utilize creative techniques to gain enrollment in rare disease clinical trials.

EXPERIENCE AND QUALIFICATIONS:

  • Phase 1, 2, 3 experience required
  • Line management and experience required
  • Excellent people interaction and communication skills, strong professional diplomacy and positive attitude a must.  Leadership skills.
  • Ability to foster a collaborative team environment, motivate others, work in teams in a matrix environment and with various levels both within company and with vendors as appropriate.
  • Excellent problem solving ability, detail oriented, excellent organizational skills, ability to multi-task, re-prioritize duties, and work effectively in a fast paced matrix environment.
  • Demonstrated competency in leading cross-functional process improvement efforts.
  • Demonstrated leadership and management skills, prior supervisory experience with demonstrated success in managing people, and expertise in mentoring and coaching.
  • Financial budgeting and resourcing planning skills.
  • Solid knowledge of ICH/GCP, regulatory guidelines/directives and drug development process. 
  • Knowledge of medical terminology.
  • Strong computer skills to include MS Office: Word, Excel and PowerPoint. 
  • BA/BS or equivalent degree in life sciences or allied health field.
  • Minimum of 10 years experience in clinical operations roles, including at least 3 years of global clinical trial experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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147) Quality Compliance Team Lead (Asso Dir/ Director) – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) JY131K

DESCRIPTION:

Summary:

Leads the QA Compliance Department and is responsible for helping interpret cGMP regulations and current industry practices for Pharma Operations. This includes adherence to Quality System and Regulatory standards, internal audits, supplier quality, third party cGMP evaluations and approval, hosting health authority inspections and all validation programs.  Oversees/manages the compliant state of affairs for all GMP activities and areas with respect to current Good Manufacturing Practices, and other federal regulations, and company policies/procedures.
Responsibilities:
  • Ensure that all activities associated with commercial product are performed according to the local Quality System and SOP’s. 
  • Responsible for the overall GMP compliance for the facility, along with Reg CMC activities to ensure compliance with filed product, post market surveillance and activities (e.g. complaint handling).  
  • Responsible for FDA and other HA compliance by making sure that quality systems are in place, and monitoring adherence.
  • Direct the compliance programs for all cGMP areas including commercial product, including production, QA/QC, Engineering/Site Services/Logistics and Pharmaceutical Technology/Contract Manufacturing Support at the sites. This includes internal / external audits (e.g. PAI, biennial, self-audits, suppliers), Third Party cGMP evaluations and approval, Change Control management and all validation programs.
  • Responsible for the device release and quality oversight of device manufacture (in relation to the commercial combo products) and will be responsible for DMR, DHR, DHF, device release, validation, deviation investigation and change controls in accordance with ISO 13485, Standards, and Health Authority regulations.
  • Responsible for products which have been released and remaining on the market meet all specifications and regulatory requirements.
  • Interprets current Good Manufacturing Practices (cGMPs) for the site and evaluates procedures relative to FDA / EU and industry standards.  Recommends changes where appropriate.  
  • Serves as key resource person during inspections in Pharma Operations.  Evaluates and/or recommends corrective actions with regard to health authority inspectional observations.
  • Where relevant, ensures a contract quality agreement program is in place for third party facilities, testing labs, complaint evaluation, investigations, equipment qualification and validation (e.g. process, cleaning, and computer validation).
  • Monitor all PharmOps Key Quality Indicators (KQI). 
  • Participate in site Quality Review Board.   
  • Responsible for ensuring that the site is in a constant state of being inspection ready.
  • Responsible for setting and achieving Quality and Compliance yearly objectives, and adhering to budgets.
  • Responsible that all individuals in compliance have appropriate education, experience, training, and procedures to complete their responsibilities.
  • Responsible for ensuring compliance with Federal (FDA), State and local regulations.  Ensure and monitor adherence to all company policies and procedures relating to cur-rent Good Manufacturing Practices
  • Responsible for liaising with the Site Validation Master plan coordinator in order to ensure all commercial validation and qualification activities are addressed, and making sure the individual commercial Master Plans are in line with the Site master plan. 
  • Provides final approval for Standard Operating Procedures, GMP Training Documenta-tion, Change Control, Validation Documentation for Production, Lab, IT (GMP systems), investigation and final batch release (as backup for QA). 
  • When permitted, has designated signature authority for Quality Head.

EXPERIENCE AND QUALIFICATIONS:

  • Working knowledge of local and global regulations and submission and approval processes for New Chemical Entities (NCE) and product life cycle management.
  • Proven track record of successfully working in inter-disciplinary teams and of simultaneously planning, coordinating and leading activities on multiple projects or equivalent experience from external company or other line function.
  • Regularly demonstrated active contributions to line functions or project teams, e.g. change or site transfer teams as well as ability to contribute to matrix teams with the necessary strategic thinking.
  • Computer literacy in MS Project, PowerPoint, document management systems, databases and ability to quickly learn new software, tracking tools and associated processes.
  • Excellence in negotiation and communication skills as well as capability to influence others in a matrix organization.
  • Excellent organizational skills.
  • Proactive and action-oriented attitude in driving projects.
  • Ability to represent the site in cross functional teams.
  • A minimum of 10 years of related pharmaceutical experience.
  • A minimum of 7 years experience working on a manufacturing site (e.g. QA, QC or production) or laboratory or equivalent experience from external company or other line function preferable.
  • A minimum of a Bachelor Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.
  • Advanced degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent is preferred.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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148) Senior Manager/Associate Director, Quality Assurance – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) K111DN

DESCRIPTION:

Support the manufacture of Drug Substance and Drug Product at Contract Manufacturing Organizations (CMO) and Contract Research Organizations (CRO) to ensure products are in compliance with Good Manufacturing Practices (GMP) and are of the appropriate quality for their intended use. The position involves managing quality operations with CMO/CRO, and liaison of quality related issues with Chemistry, Manufacturing and Control (CMC) Team and functional areas.

Responsibilities

  • Must have the ability to execute QA tasks independently, effectively represent QA in CMC team setting, and interface with CMO/CRO.
  • Review Drug Substance/Drug Product master and executed batch records
  • Review clinical packaging/labeling master and executed batch records
  • Manage CMO/CRO change control, deviation & CAPA systems
  • Conduct supplier audits
  • Maintain and improve quality systems
  • QA review of test method validation/transfer
  • QA review of equipment/instrument qualification
  • Represent QA in cross-functional projects
  • Assume tasks in quality assurance area as required

EXPERIENCE AND QUALIFICATIONS:

  • Must be familiarity with quality management of solid dosage forms (tablet, capsule)
  • Experienced in conducting GMP audits
  • Quality control and/or analytical development background helpful
  • Small molecule synthesis and purification knowledge desirable
  • Working knowledge in CMC process
  • Good interpersonal and writing skills
  • Self motivated, independent, and collaborative
  • Travel required (around 20%)
  • 10+ years of quality assurance background in pharma/biotech industry, with hands-on role in quality operations and quality systems
  • 3+ years hands-on QA experience in working with CMO/CRO
  • B.S./M.S. in relevant science field

To apply for a position send your resume to Jobs@JGBBioPharma.com

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149) Senior Manager / Associate Director, Clinical Quality Assurance – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) AL111H

DESCRIPTION:

Support the Clinical Quality Assurance program. The incumbent will conduct and manage Good Clinical Practice (GCP) related quality audits (e.g., investigator site and vendor qualification); support development and improve the existing GCP related quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures and protocols. The incumbent is also responsible for developing specific internal procedures, training of staff and hosting regulatory inspections. The position involves managing global clinical quality operations and liaison of clinical quality related issues with functional areas.

Responsibilities:

  • Must have the ability to execute CQA tasks independently; effectively represent QA in a GCP driven team setting and interface with clinical vendors, investigator sites and regulatory agencies.
  • Must actively participate in sustaining a level of inspection readiness of clinical stakeholders and act as a catalyst for continuous process improvement.
  • Develop GCP related quality system SOPs in compliance with all applicable regulatory requirements and to align with existing company policy.
  • Ensure clinical trials are performed in accordance with applicable study protocols and are in compliance with all applicable regulatory requirements.
  • Manage/conduct quality audits of investigator sites and various clinical vendors.
  • Manage/conduct quality audits of clinical study documents, which include investigator brochures, clinical protocols and clinical study reports, case report forms and informed consents forms.
  • Manage/conduct internal audits to ensure stakeholder system compliance with existing policies and procedures, and GCP requirements, standards and guidelines.
  • Provide expert CQA advice to stakeholders (e.g., Clinical Operations, Data Management, Pharmacovigilance, etc.) based on analysis and interpretation of GCP regulations.
  • Support the administration of the company’s training program by conducting GCP training to internal departments and externally, as applicable.
  • Manage/conduct targeted training of investigators/site staff.
  • Report GCP related deficiencies to QA management as well as plans for corrective and/or preventive actions (CAPA).
  • Assist clinical study teams in the development of CAPAs.
  • Assist with tracking GCP compliance audit trends and group metrics and presenting metrics driven data to upper management.
  • Coordinate responses to regulatory agency inspections.

EXPERIENCE AND QUALIFICATIONS:

  • Current and strong working knowledge interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research.
  • Excellent verbal and written communication skills, ability to lead cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for regulatory compliance.
  • Position requires a highly diplomatic, tactful and detail oriented individual with exceptional critical reasoning skills.
  • Ability to use expertise and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways
  • Ability to deal with ambiguity, creative and pragmatic approach to problem solving
  • Travel will be required between 30 to 50% of the time
  • Auditor and/or GCP certifications a plus
  • 10+ years of progressive global quality assurance background in pharma/biotech and medical device industries, with a hands-on role in quality operations and quality systems
  • 5+ years hands-on CQA/GCP Compliance experience
  • B.S./M.S. in relevant science field

To apply for a position send your resume to Jobs@JGBBioPharma.com

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150) Associate Director / Director, Quality Assurance – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) W111EC

DESCRIPTION:

The position involves managing quality operations with CMO/CRO, and liaison of quality related issues with Chemistry, Manufacturing and Control (CMC) Team and functional areas with focus on Oral solid dosage form products.
The successful candidate must have the ability to execute QA tasks independently, effectively represent QA in CMC team setting, and interface with CMO/CRO.

Responsibilities
  • Review Drug Substance/Drug Product master and executed batch records
  • Review clinical packaging/labeling master and executed batch records
  • Manage CMO/CRO change control, deviation & CAPA systems
  • Conduct supplier audits
  • Maintain and improve quality systems
  • Test method validation/transfer
  • Equipment/instrument qualification
  • Represent QA in cross-functional projects
  • Assume tasks in quality assurance area as required

EXPERIENCE AND QUALIFICATIONS:

  • 10+ years of quality assurance background in pharma/biotech industry, with hands-on role in quality operations and quality systems
  • 3+ years hands-on QA experience in working with CMO/CRO
  • B.S./M.S. in relevant science field
  • Quality control and/or analytical development background helpful
  • Small molecule synthesis and purification knowledge required
  • Understanding of oral dosage forms technology (tablet, capsule) required
  • Working knowledge in CMC process a plus
  • Good interpersonal and writing skills
  • Self motivated, independent, and collaborative
  • Some travel may be required

To apply for a position send your resume to Jobs@JGBBioPharma.com

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151) Senior Scientist (Process Chemical Development) – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) PH111X

DESCRIPTION:

  • Reporting to the Department Senior Director, the successful incumbent will work on all process chemistry aspects of new small molecule pharmaceuticals
  • Designing, proving in the laboratory, developing, and optimizing GTI free synthetic organic processes/procedures to prepare new small molecule drug substances
  • Timely internal preparation of appropriate quantity and quality small molecule drug substances, intermediates, reference materials, metabolites, impurities, and degradation products
  • Assisting in isolation and identification of impurities and modifying processes to control impurity levels
  • Assisting in oversight of CMO activities related to technology transfer, development, optimization, scale-up and manufacture of drug substance and related materials
  • As needed, providing on-site monitoring of drug substance manufacturing at contract sites, and support of investigations and deviations
  • Reviewing, verifying and approving process documentation and batch records for cGMP drug substance manufacturing
  • Regularly reporting work status and preparing written reports on work performed
  • Reviewing drug substance documentation and reports for technical accuracy in support of regulatory filings
  • Cooperatively working with personnel in other departments: Analytical Development, Formulation Development, Medicinal Chemistry, Quality Control, Quality Assurance, Regulatory Affairs, and Project Management

EXPERIENCE AND QUALIFICATIONS:

  • Able to design synthetic routes and complex procedures for defined compounds
  • Analytical skills such as HPLC, GC, LC-MS, NMR, FTIR, DSC
  • Experienced writing reports on synthetic processes
  • Team player with ability to positively communicate with team members
  • Knowledge and understanding of cGMP regulations and ICH guidance
  • Knowledge and understanding of the CMO industry and sources of commercial chemicals
  • Experience with chemical scale-up, manufacturing batch record preparation, technology transfers, and knowledge of larger scale GMP chemical synthesis
  • Hands-on experience with pilot plant scale-up and/or larger scale chemical synthesis desirable
  • Ability to manage multiple projects simultaneously and work independently under limited supervision
  • Proficiency with word-processing, spreadsheet, chemical drawing, statistical, and project management software (i.e. MS Word, Excel, ChemDraw, JMP or Design Expert, MS Project)
  • PhD in synthetic and/or mechanistic organic chemistry
  • At least 8 years experience with 5+ years in chemical process development of small molecules and in developing and optimizing chemical processes

To apply for a position send your resume to Jobs@JGBBioPharma.com

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152) Scientist / Senior Scientist, Analytical Development (Small Molecules) – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) AL111W

DESCRIPTION:

  • Develop methods for characterizing and release testing of small molecule drug substance and drug product therapeutics. 
  • Develop methods, qualify, and validate methods and transfer methods to QC for QC testing. 
  • Provide analytical support to chemists performing process development activities. 
  • In addition to strong chromatography and mass spectrometry skills, experience with dissolution testing, particle size measurements, NMR, FTIR, DSC, TGA, ICP, XRPD, and other analytical techniques are a plus.
  • Developing and optimizing HPLC methods to report impurities and assay of small molecule drug substances and drug products
  • Qualification and validation of methods and transfer of methods to QC
  • Working with contract laboratories
  • Writing protocols and reports suitable for regulatory submissions

EXPERIENCE AND QUALIFICATIONS:

  • Demonstrated expertise with HPLC methodologies is required.
  • Experience with mass spectrometry is required.
  • Experience and knowledge of method qualification and validation is necessary.
  • Strong communication skills, verbal and written, and a team-oriented approach are required.
  • Will be organized, self-motivated, and able to work both independently and as part of a team.
  • Excellent writing skills are required.
  • BS or MS with a minimum of 6+ years of industry experience or equivalent, or a PhD with a minimum of 2+ years of industry experience is required. Title will be dependent upon experience level.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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153) Clinical Pharmacologist – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) A133GB

DESCRIPTION:

  • Reporting to the SVP, Clinical Research and Development, the Medical Director will be responsible principally for early clinical drug development activities with a strong focus on Phase I and Phase IIa clinical trials.  
  • Will work closely with members of the R&D team to ensure a strategic view is taken for the pipeline progression of individual projects. 
  • In collaboration with others in Clinical Research and Development, design and execute clinical studies (ADME, special populations, pharmacokinetic, and pharmacodynamic) to support existing and new compounds in development.
  • Responsible for the medical oversight and conduct of clinical pharmacology studies
  • Identify, evaluate, and interact with clinical study sites including assessment of strengths and weakness of medical functions  
  • Responsible to contribute to, review, and finalize clinical study reports of clinical pharmacology studies
  • Interact with regulatory authorities as required in support of ongoing development programs 
  • Medical monitor in sponsored studies as appropriate, ensure that the clinical teams correctly handle all adverse events (AEs) and serious adverse events (SAEs) in accordance with ICH standards 
  • Correctly apply the ICH and GCP regulations surrounding the primary activities of clinical development projects 
  • Operate within the time and budget constraints of the clinical program 
  • Communicate project-related information, including responsibility for planning and preparation for meetings and presentations 
  • Coordinate and complete scientific documents including protocols, clinical study reports, other regulatory documents
  • Collaborate with biometrics, bioanalysis, and clinical operations to achieve study objectives
  • Interact effectively with counterparts at collaboration partners to accomplish company objectives related to strategic partnerships  

EXPERIENCE AND QUALIFICATIONS:

  • Randomized controlled clinical trial principles, methodology and procedures 
  • Adverse medical event investigation, analysis, as well as reporting procedures and standards 
  • Extensive knowledge of clinical pharmacokinetics and modeling principals
  • FDA and EMA regulatory requirements and ICH/GCP guidelines is an asset 
  • Federal and state regulations and guidelines pertaining to the conduct of clinical trials on human subjects 
  • Statistical data collection, editing, validation and analysis techniques 
  • Current and developing trends and standards in clinical trials monitoring 
  • Industrial standards as applied to GCP and GLP 
  • Infrastructure and operational characteristics of Contract Research Organizations (CROs) and centralized clinical laboratories 
  • Ability to develop and implement clinical research protocols and study specific procedures 
  • Ability to communicate, interact and present competently and professionally both verbally and in writing at all levels within a broad, complex clinical research environment including third parties such as partners, CRO’s, and academia 
  • Travel up to 30% as necessary according to project needs
  • Registered Medical Doctor (mandatory qualification) 
  • Board certification/specialist registration in clinical pharmacology highly desirable or significant prior relevant experience
  • 7-10 years of experience in drug development in the pharmaceutical and/or biotech industry, covering both early and translational phase development or significant participation in industry sponsored research as a clinical investigator
  • PhD in clinical pharmacology would be an asset 

To apply for a position send your resume to Jobs@JGBBioPharma.com

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154) CRA I /II – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) S117JT

DESCRIPTION:

  • Responsible for implementing and monitoring clinical trials and expands experience in clinical trial and vendor management procedures.  
  • Works closely with study coordinators and investigators to ensure compliance with protocol and overall clinical objectives. 
  • Identifies projects/tasks and works with Clinical Trial Manager to complete.  
  • Demonstrates ability to carry out all CRA I functions with minimal supervision.  
  • In collaboration with manager and/or Lead CRA, maintains consistent CRF data quality and discrepancy interpretation across sites.   
  • May conducts site visits (pre-study, initiation, interim and close-out visits) to ensure protocol compliance, accurate and thorough data collection, and appropriate study conduct
  • Develops study tools and guidelines to be utilized by study sites
  • Assists in the process used to evaluate and select potential investigators and sites
  • Interacts with investigators and study coordinators through frequent communication (written and verbal) and maintains effective management of study issues and assigned sites
  • Understands study timelines and manages sites to meet timelines
  • Collaborates with team to maintain consistent CRF data quality and discrepancy resolution across sites
  • Performs manual, in-house review of CRF data in clinical database for completeness and accuracy
  • Reviews site’s informed consents against the consent template for presence of all GCP requirements and protocol specific information. 
  • Coordinates and reviews regulatory documents from study sites; ensures completeness and accuracy; Ensures study records are auditable both at investigational sites and in-house
  • Responsible for initiating and tracking quarterly site payments

EXPERIENCE AND QUALIFICATIONS:

  • Verbal and written communication skills are required.  
  • Attention to detail and organizational skills
  • Working knowledge of GCP and FDA regulations
  • Proficiency in MS Word, Excel and PowerPoint
  • 2+ years of CRA experience in an industry setting, or four years of pharmaceutical/health care field experience including 1 year previous experience as a CRA.
  • Experience in clinical research at a pharmaceutical/biotech company; 
  • BS/BA degree in a life science, RN, or related field

To apply for a position send your resume to Jobs@JGBBioPharma.com

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155) (Senior) Associate Manager CMC Regulatory – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) MA132W

DESCRIPTION:

  • Responsible for supporting the CMC regulatory strategy and coordinating the process for compiling CMC section of regulatory submissions.
  • Reviews CMC documentation to ensures they meet regulatory requirements.
  • Coordinates CMC regulatory  workflow between departments as well as CROs
  • Coordinates and compiles CMC document packages and investigational drug shipment related activities for drug manufacturing according to regulations/guidelines and company SOPs
  • Assembles, coordinates and compiles  technical documents needed to complete CMC section of regulatory submissions.
  • Acquires and maintains current knowledge of applicable regulatory requirements and scientific/technical issues in the area of small molecule pharmaceuticals.
  • Assists in the coordination of drafting of responses to regulatory questions in a timely manner.
  • Assists in the review of change controls and provides regulatory impact assessment as needed. 
  • Escalates issues that affect registration, and regulatory compliance to CMC Regulatory Affairs Management

EXPERIENCE AND QUALIFICATIONS:

  • Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills
  • Proficient with computer (MS Office) and internet skills.
  • Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from a variety of multifaceted activities, demanding regulatory requirements, commitment to highest quality and the requirements of pharmaceutical partnering are absolutely necessary.
  • Proven ability to communicate with executive management, cross-functional team members and operational staff.
  • Flexible attitude with respect to work assignments, and new learning.
  • 1 to 6 years relevant regulatory CMC  experience
  • BS in Chemistry; Advanced degree preferred. (MS, PhD or PharmD or equivalent)

To apply for a position send your resume to Jobs@JGBBioPharma.com

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156) Sr Manager , Scientific & Technical Publishing – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) R132GL

DESCRIPTION:

Summary:

Responsible for the publication of regulatory documents according to regulatory authority specifications and department standards for paper and electronic submissions. Assists in the development of electronic submissions standards and tools.  The Manager/Sr. Manager, Regulatory Publishing also coordinates the review and revision of all regulatory documents for submission to regulatory agencies.  This position generally receives no instruction on routine work but detailed instruction on new assignments.

Responsibilities:
  • Integrates data from various electronic or paper sources into either electronic or paper submissions using format and style essential for regulatory compliance with established operating procedures, and current medical and technical writing standards. 
  • Must collaborate effectively with contract team members to publish, copy, assemble, quality check, and publish required documents.  
  • In addition, he/she will continue to develop expertise through participation in both internal and external technical training. 
  • Demonstrate proficiency in required software.
  • Provide word processing, advanced formatting, and publishing assistance to Regulatory and Clinical personnel.
  • Create and maintain templates for regulatory submissions.
  • Assist in maintenance of Regulatory archives.
  • Assist with the incorporation of document comments from multiple reviewers including text, graphs, charts, tables and statistical analysis
  • Review documents for format compliance to current style guidelines and correct deficiencies within timeline
  • Assist with the coordination of regulatory document routing, revision tracking, proof-reading, and document approvals
  • May perform additional tasks and duties as assigned

EXPERIENCE AND QUALIFICATIONS:

  • Basic understanding of the US, EU, and ICH regulations and guidelines.
  • Demonstrated proficiency in MS Office including advanced use of styles, automated table of contents and cross-references, version control, change tracking, indexes, styles, macros, charts and embedded graphics, forms and toolbars; assist in bookmarking, hyperlinking, and compiling electronic submissions within Adobe Acrobat.
  • Strong technical background including proficiency in document publishing, desktop publishing, scanning, Microsoft Office, Adobe Acrobat, PowerPoint, standard graphics and publishing software, Endnote, MS Project, etc.
  • Follow proofreading marks, use accepted styles and terminology, provide limited copyediting.
  • Ability to work independently with minimal supervision.
  • Strong interpersonal skills.
  • Demonstrated verbal and written communication skills.
  • Ability to multi-task, pay close attention to detail, and follow projects through to completion.
  • Excellent organizational, prioritization, and planning skills.
  • 6-8 years related experience in publication and scanning of assorted documents or images supporting regulatory submissions; requires previous experience in regulatory submissions, license applications, etc., within the pharmaceutical, biotech, or related field.
  • Bachelor’s degree desired or equivalent relevant experience in Regulatory Publishing

To apply for a position send your resume to Jobs@JGBBioPharma.com

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157) Senior Medical Director, Drug Safety – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) P111BL

DESCRIPTION:

  • Provide global medical leadership and input into all aspects of safety of assigned molecule or therapeutic area including surveillance programs, aggregate review and risk management planning.
  • Proactive safety review of aggregate safety data including signal detection
  • Support clinical team in developing safety section for protocol, informed consent, and investigator brochure
  • Participate in activities related to Independent safety data monitoring committee (ISDMC)
  • Analyze integrating safety data from completed clinical studies
  • Review and provide input on the safety section for clinical study reports
  • Develop strategy and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committee
  • Ensure timely preparation for risk management strategies (RMP, REMS), including risk minimization measures
  • Timely preparation of periodic reports (DSUR)
  • Maintain compliance with corporate policies, standard operating procedure and global regulation
  • Lead the discussion on safety issue cross-functionally
  • Participate in development, review and update of safety exchange agreement with collaborators
  • Prepare and participate in regulatory review meetings
  • Participate in audits and inspection
  • Prepare and share safety information with licensing partners, review safety documents prepared by licensing partners, communicate safety matters with partners per the safety data exchange agreement
  • Provide training, coaching and mentorship to safety scientists
  • Represent and champion the role of safety in the organization

EXPERIENCE AND QUALIFICATIONS:

  • Knowledge of processes and global regulations governing pharmacovigilance and risk management
  • Drug development
  • Safety data capture
  • MedDRA and other dictionary used in pharmacovigilance
  • Knowledge of methods of qualitative and quantitative safety data analysis
  • General medicine, epidemiology, physiology and pharmacology
  • Signal detection, aggregate data analysis and evaluation
  • Good clinical and scientific judgment
  • Strategic thinking and leadership
  • Effective team work, influencing and negotiation in a cross-functional environment
  • Ability to work with collaborators and licensing partners
  • Good organizational skills,
  • Strong leadership ability in negotiation, communication and networking
  • Problem solving
  • Develop solutions in coordination with key decision makers
  • Executes goals and department strategy
  • Detailed knowledge of current pharmacovilance environment, regulations and processes
  • MD, DO or equivalent from accredited medical school
  • 7+ years in the pharmaceutical or biotech industry
  • 5+ years in drug safety and pharmacovigilance
  • Experienced managing/supervising staff

To apply for a position send your resume to Jobs@JGBBioPharma.com

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158) Medical Director, Drug Safety – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) TM111Z

DESCRIPTION:

  • Provide global medical leadership and input into all aspects of safety of assigned molecule or therapeutic area including surveillance programs, aggregate review and risk management planning.
  • Proactive safety review of aggregate safety data including signal detection
  • Support clinical team in developing safety section for protocol, informed consent, and investigator brochure
  • Participate in activities related to Independent safety data monitoring committee (ISDMC)
  • Analyze integrating safety data from completed clinical studies
  • Review and provide input on the safety section for clinical study reports
  • Develop strategy and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committee
  • Ensure timely preparation for risk management strategies (RMP, REMS), including risk minimization measures
  • Timely preparation of periodic reports (DSUR)
  • Maintain compliance with corporate policies, standard operating procedure and global regulation
  • Lead the discussion on safety issue cross-functionally
  • Participate in development, review and update of safety exchange agreement with collaborators
  • Prepare and participate in regulatory review meetings
  • Participate in audits and inspection
  • Prepare and share safety information with licensing partners, review safety documents prepared by licensing partners, communicate safety matters with partners per the safety data exchange agreement
  • Provide training, coaching and mentorship to safety scientists
  • Represent and champion the role of safety in the organization

EXPERIENCE AND QUALIFICATIONS:

  • Knowledge of processes and global regulations governing pharmacovigilance and risk management
  • Drug development
  • Safety data capture
  • MedDRA and other dictionary used in pharmacovigilance
  • Knowledge of methods of qualitative and quantitative safety data analysis
  • General medicine, epidemiology, physiology and pharmacology
  • Signal detection, aggregate data analysis and evaluation
  • Good clinical and scientific judgment
  • Strategic thinking and leadership
  • Effective team work, influencing and negotiation in a cross-functional environment
  • Ability to work with collaborators and licensing partners
  • Good organizational skills,
  • Strong leadership ability in negotiation, communication and networking
  • Problem solving
  • Develop solutions in coordination with key decision makers
  • Executes goals and department strategy
  • Detailed knowledge of current pharmacovilance environment, regulations and processes
  • MD, DO or equivalent from accredited medical school
  • 5+ years in the pharmaceutical or biotech industry
  • 3+ years in drug safety and pharmacovigilance

To apply for a position send your resume to Jobs@JGBBioPharma.com

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159) Director CMC Regulatory – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) XF132H

DESCRIPTION:

  • Responsible for ensuring the CMC regulatory strategy is in alignment with the global regulatory strategy and leading and coordinating the  process for compiling the CMC section of regulatory submissions.
  • Work with cross-functional project teams to develop CMC regulatory strategy and ensure success of regulatory filings.
  • Reviews CMC documentation to ensures they meet regulatory requirements.
  • Represents RA CMC  at project team meetings and coordinates regulatory  workflow between departments as well as CROs
  • Coordinates, writes, compiles  CMC  document packages and investigational drug shipment related activities  for  drug manufacturing  according to regulations/guidelines and company SOPs
  • Participates in specification committee meetings and reviews/approves specification changes.
  • Assembles, coordinates and compiles technical documents needed to complete CMC section of regulatory submissions.
  • Acquires and maintains current knowledge of applicable regulatory requirements and scientific/technical issues in the area of small molecule pharmaceuticals.
  • Coordinates drafting of responses to regulatory questions in a timely manner.
  • Reviews Change controls and provides regulatory impact assessment. Ensures appropriate regulatory filings are completed in a timely manner.
  • Participates in Regulatory Affairs initiatives to improve standards and systems.
  • Escalates issues that affect registration, and regulatory compliance to CMC Regulatory Affairs Management

EXPERIENCE AND QUALIFICATIONS:

  • Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills
  • Proficient with computer (MS Office) and internet skills.
  • Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from a variety of multifaceted activities, demanding regulatory requirements, budgetary responsibility, commitment to highest quality and the requirements of pharmaceutical partnering are absolutely necessary.
  • Proven ability to communicate with executive management, cross-functional team members and operational staff.
  • Flexible attitude with respect to work assignments, and new learning.
  • 8+ years relevant regulatory CMC  experience
  • BS and advanced degree in life sciences (MS, PhD or PharmD or equivalent)

To apply for a position send your resume to Jobs@JGBBioPharma.com

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160) Manager / Sr. Manager CMC Regulatory – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) B132WN

DESCRIPTION:

  • Responsible for ensuring the CMC regulatory strategy is in alignment with the global regulatory strategy and lead/coordinate the process for compiling CMC section of regulatory submissions.
  • Reviews CMC documentation to ensures they meet regulatory requirements.
  • Represents RA CMC at project team meetings and coordinates regulatory  workflow between departments as well as CROs
  • Coordinates, writes, compiles CMC document packages and investigational drug shipment related activities for drug manufacturing  according to regulations/guidelines and company SOPs
  • Assembles, coordinates and compiles  technical documents needed to complete CMC section of regulatory submissions.
  • Acquires and maintains current knowledge of applicable regulatory requirements and scientific/technical issues in the area of small molecule pharmaceuticals.
  • Coordinates drafting of responses to regulatory questions in a timely manner.
  • Assists in the review of change controls and provides regulatory impact assessment as needed. 
  • Ensures appropriate regulatory filings are completed in a timely manner.
  • Participates in Regulatory Affairs initiatives to improve standards and systems.
  • Escalates issues that affect registration, and regulatory compliance to CMC Regulatory Affairs Management

EXPERIENCE AND QUALIFICATIONS:

  • Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills
  • Proficient with computer (MS Office) and internet skills.
  • Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from a variety of multifaceted activities, demanding regulatory requirements, commitment to highest quality and the requirements of pharmaceutical partnering are absolutely necessary.
  • Proven ability to communicate with executive management, cross-functional team members and operational staff.
  • Flexible attitude with respect to work assignments, and new learning.
  • 6+ years relevant regulatory CMC  experience
  • BS in Chemistry. 
  • Advanced degree preferred. (MS, PhD or PharmD or equivalent)

To apply for a position send your resume to Jobs@JGBBioPharma.com

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161) Sr Clinical Supply Chain Coordinator – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) R132BN

DESCRIPTION:

Summary:
Manage global clinical drug supply activities such as secondary packaging vendor selection, technical batch record review, clinical label design, label translation coordination, packaging and labeling, IXRS oversight, distribution tracking, product returns and destruction coordination.  Manage secondary packaging vendors to ensure timelines are met.  Provide Supply updates at weekly Study Management and Vendor Team meetings. 

Responsibilities:
  • Supply support for Clinical Operations
  • Manage select clinical drug supply activities
  • Provide supply input on study protocols
  • Identify secondary packaging suppliers based on clinical product requirements
  • Attend weekly Study Management Team meetings
  • Conduct weekly vendor update calls
  • Provide status updates to Clinical Operations
  • Coordinate clinical label text review and approvals
  • Coordinate clinical label translations for global studies
  • Perform technical packaging batch record review
  • Oversee packaging at secondary packaging sites
  • Ensure packaging timelines are met
  • Ensure products are released by required dates
  • Coordinate product shipment/transfers with vendors and Logistics
  • Temperature excursion management/evaluation
  • Coordinate post study product return activities
  • Update/develop required Clinical Drug Supply SOP’s
  • Establish Clinical Supply set up requirements
  • Generate required SOP’s

EXPERIENCE AND QUALIFICATIONS:

  • Previous Clinical Drug Supply experience required
  • Understanding of cGMP’s and pharmaceutical industry procedures and regulations.
  • Ability to plan, budget and organize.
  • Strong, open and transparent communication skills (verbal and written).
  • Solid organizational and time management skills.
  • Project management skills and computer proficiency.
  • Experience with:  MS Excel, Word, Project.  
  • Bachelor’s degree in business or biological sciences with minimum of 5 years experience in GMP supply chain or pharmaceutical program management.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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162) Associate Scientist II - R&D – Contract (San Francisco Bay Area) 1144F73

DESCRIPTION:


  • Create new SKUs using SKU wizard
  • ECO request of new part release through Agile
  • Write processing documents
  • Support work related to SAP and Agile database
  • Work with various stakeholders: following up the progress of ECO, and facilitating the resolution of any issues.
  • Support Tech Transfer group in lab testing of assays.

EXPERIENCE AND QUALIFICATIONS:

  • Familiar and experienced with SAP and Agile.  
  • If only experienced in SAP, familiar in general ERP system to be trained on Agile quickly. 
  • Basic knowledge in ERP system is must.
  • Requires a Bachelor's degree in Biology, Chemistry, Biochemistry, or other related discipline, or the equivalent knowledge and experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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163) Clinical Program Manager – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) B94RP

DESCRIPTION:

  • Accountable for successfully overseeing program level execution of all clinical operations deliverables, and leads the clinical program team to meet program goals and objectives.
  • Assists in the planning and execution of clinical projects while adhering to budget, scope and schedule requirements
  • Responsible for the execution of a suite of clinical trials from protocol design to the final clinical study report
  • Creates and maintains clinical program timelines for study start-up, maintenance and close-out
  • Attend clinical meetings and inform members of relevant clinical program updates
  • Ensure study timelines are met, and study progress is tracked and reported
  • Work with the clinical scientist and medical monitor to develop protocols and all documents required to initiate and conduct clinical studies (includes informed consent forms, investigator brochures, case report forms, etc.)
  • Oversee performance of CROs and/and or regional CRAs to ensure compliance to the protocol and regulations, including attending site visits, co-monitoring and review of IMV reports
  • Select and manage vendors required to conduct clinical studies (includes overseeing contracts, payments, and deliverables to ensure quality of service provided)
  • Select study investigators and evaluate adequacy to perform research and meet study timelines
  • Develop, implement, and manage project-level clinical budgets and timelines (includes communicating initial strategies and changes to project team as appropriate)
  • Develop, implement, and manage monitoring plans (may include some site visits to manage site and vendor relationships and to ensure quality of data/services)
  • Oversee study drug supply and ensure the project team is updated on all new developments or changes in supply needs
  • Identify project risks and proactively create and implement mitigation strategies
  • Collaborate effectively with cross-functional management teams and external partners
  • Communicate with management to ensure adequate resources are assigned to achieve program deliverables
  • Mentor CRAs and other operational personnel
  • May manage direct reports (contract, term &/or FTE)
  • Coordinate and participate in investigator meetings

EXPERIENCE AND QUALIFICATIONS:

  • Thorough knowledge of personal computers and MS Office Suite.
  • Knowledge of GCP and ICH guidelines required.
  • Bachelor's degree in a relevant scientific discipline or equivalent.
  • 8+ years of independent clinical trial management experience (including vendor management) as a CRA in the pharmaceutical industry and additionally 0-2 years of experience as a clinical project manager responsible for the implementation of multiple concurrent clinical trials.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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164) Senior Java Software Engineer – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) RF103P

DESCRIPTION:

  • Design and develop high performance components/sub-systems for a highly scalable service oriented NGS software
  • Assist in defining the appropriate data models, transformation technologies, and indexing/search algorithms for large-scale genomics data.
  • Use best practices and architectural rigor during the software design process, providing input on alternative strategies and solutions.
  • Write well-documented, extensible software code that is easy to maintain, and that adheres to generally accepted programming standards and OOP practices.
  • Own the overall quality of your code including unit testing, functional testing and performance.
  • Produce and maintain technical designs and documentation relevant to assigned software development tasks.

EXPERIENCE AND QUALIFICATIONS:

  • Highly proficient in JAVA and strong understanding of multi-threaded programming
  • Excellent grasp of OOP concepts and design patterns
  • Experience analyzing and defining requirements, and translating them into technical specifications and architecture
  • Knowledge of DBMS and database architecture and normalization
  • Expertise in one or more technologies like Lucene, Hadoop, Storm, No-SQL database
  • Knowledge of scalability/performance issues and optimization techniques
  • Experience with Web Services (such as Spring and RESTful)
  • Experience with source control and issue tracking systems as well as debugging tools
  • Strong problem solving, analytical and object-oriented programming skills
  • Excellent verbal and written communication skills, teamwork, and time management abilities
  • 5+ years of developing highly scalable, fault-tolerant, distributed backend services for web applications
  • Preferred Bachelor’s degree or equivalent experience in bioinformatics, or computer science with knowledge of Next Generation Sequencing technologies

To apply for a position send your resume to Jobs@JGBBioPharma.com

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165) Supply Chain Manager – Contract (San Francisco/Peninsula/South Bay/East Bay/Marin Area) T82BL

DESCRIPTION:

Overview:
Responsible for supporting all clinical supply chain activities. Primary duties will include but the oversight of clinical supply CMOs including packaging, labeling  and distribution of IP (investigational product), preparation of label texts and specifications, review of packaging specifications and distribution instructions, submitting and tracking  drug orders, coordinating with clinical operations staff, reviewing and processing temperature data, coordinating domestic and international shipments, tracking and maintaining inventories according to supply plans and study requirements, and document management.

The incumbent will work on a wide range of diverse to complex problems in which analysis of data and/or situations requires an in-depth evaluation of identifiable factors. This position will exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining solutions. 

Responsibilities:
  • Under minimal supervision, manage and execute against drug supply plans in support of clinical programs
  • Coordinate labeling packaging and shipment of packaged supplies: preparation and review of labels proofs and Specifications, preparation and review of Product Packaging Specifications, and preparation and review of Study Distribution Instructions and return Instructions.
  • Requires project management skills including time line generation, action tracking, meeting facilitation, effective communication skills and good documentation practices. 
  • Develop effective relationships with partners across a wide range of staff levels.
  • Develop effective relationships with internal and external partners in supply chain.
  • Assess issues with regards to study design, supply availability and timeline.
  • Promptly identify and escalate risks to study supply to all key stakeholders and internal management.
  • Represent GTO (Global Technical Operations) Clinical Supply Chain in cross-functional clinical study meetings 
  • Work closely with Clinical Supply Chain management to participate in the building and maintenance of clinical study supply plans:
  • Strategize with study managers and review study protocols to determine appropriate packaging configurations, blinding techniques, and optimal distribution plans.
  • Determine distribution strategies for clinical studies.
  • Participate in planning meetings to ensure that project needs, priorities and timing are understood.

EXPERIENCE AND QUALIFICATIONS:

  • Strong understanding of clinical trial design, execution and impact of IP (investigational product) supply. 
  • Proven experience working either in house or with clinical supply CMOs on the execution of packaging, labeling and distribution of IP. 
  • Strong knowledge and understanding of GMP and/or GCP
  • Experience or familiarity with IXRS and managing the forecasting planning of clinical drug supply needs considered a plus.
  • Self-directed with the proven ability to work autonomously.
  • Must possess the ability and desire for problem solving and decision making in a cross-functional team setting.
  • High attention to detail, excellent organizational skills and the ability to work on multiple projects with tight deadlines. 
  • Solid interpersonal and communications skills and the ability to deal effectively with a variety of personnel both internally and outside the company. 
  • Proficient in MS-Office (Excel, Word, PowerPoint, Outlook).  
  • Knowledge of Microsoft Visio and Project considered a plus.
  • Flexible, high level of integrity, action and goal-oriented. Balances process and theory with practical application and good judgment. Enjoys a fast-paced, team-oriented, and collaborative environment.
  • Bachelor of Science in life sciences is preferred. Work experience may be substituted for education. 
  • Minimum 4 years in life science industry related experience including Project Management, Pharmaceutical Development, Clinical Supply Management, and/or Clinical Trails Coordination.
  • At least 2 years direct experience in clinical supplies environment
  • Experience in clinical trial supplies required

To apply for a position send your resume to Jobs@JGBBioPharma.com

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166) Senior Clinical Research Associate – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) F128KZ

DESCRIPTION:

Overview: 
Ensure timely conduct of clinical studies according to protocols, Good Clinical Practice, Standard Operating Procedures and all applicable regulations governing the conduct of clinical trials. Position reports to Associate Director, Clinical Operations.

Responsibilities:
  • In conjunction with Associate Director, coordinate activities of clinical trial sites.
  • Attend Site Qualification Visits to assess investigator’s staff and facilities.
  • Contribute to study design and initiate planning for global programs (Protocol Amendments and ICF template revisions; Case Report form design and review; Patient instruction cards, and other study materials).
  • Assist in the preparation and review of supportive study documents and study plans (Monitoring Plan, Lab Manuals, Project Plans, IWRS, CRF Guidelines).
  • Ensure all local regulatory approvals are in place for conduct of trial.
  • Conduct study initiation visits, including training of on-site personnel in all aspects of study requirements.
  • Conduct monitoring visits to the sites at intervals specified in monitoring plan.
  • Assist in auditing of clinical trial data for accuracy and consistency and arrange correction of errors as appropriate.
  • Identify, assess and implement appropriate activities to ensure trial progress.
  • Coordinate supplies for specimen collection and shipment of samples for assays.
  • Monitor supply of investigational and comparator drug supply throughout the trial.
  • Assist with product accountability at site and take appropriate action to resolve discrepancies.
  • Report adverse events per protocol and Standard Operating Procedures.
  • Conduct study close-out visits.
  • Document all trial information with adherence to applicable guidelines and Standard Operating Procedures.
  • Remain current with study data.
  • Maintain high level of familiarity with clinical literature of study area.

EXPERIENCE AND QUALIFICATIONS:

  • Preferred knowledge of FDA regulatory requirements and medical practice/techniques and terminology.
  • Ability to work within a team.
  • Excellent communication and interpersonal skills.
  • Attention to detail and highly organized.
  • 25% travel.
  • BA/BS in Life Science or related discipline.
  • 2-5 years of experience in clinical study coordination.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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167) Specialist, Quality Assurance – 6-12 Month Contract (San Francisco Bay Area) G94LT

DESCRIPTION:

SUMMARY:
Works on problems of diverse scope where the analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods, techniques for obtaining solutions.  Normally receives no instructions on routine work and general instructions on new assignments.  Works on assignments that are often highly complex in nature where judgment is required in resolving problems and making routine recommendations.

DUTIES:
  • Perform cGMP/cGLP audits of internal departments and external contractors.
  • Manage, evaluate, and approve Quality System documentation including deviations, CAPA’s, and planned changes.
  • Evaluate document changes for compliance requirements (SOPs, specifications, test methods, etc.).
  • Evaluate compliance of completed manufacturing documents (batch records forms, etc.) and completed QC documents (test results, analytical methods, and bills of testing, etc.) according to Production schedules.
  • Interact with Manufacturing, Fermentation Development, and Quality Control to continually improve compliance with quality systems, internal SOPs, and regulatory requirements and to resolve minor and major deviations.
  • Participate as required in investigatory teams to resolve major quality issues.
  • Participate in compliance audits of quality systems, manufacturing areas, vendor, QC, and support functions as required.
  • Prepare lot release packets in standardized format for upper management review and disposition.
  • Approve areas before use (line and room clearances).

EXPERIENCE AND QUALIFICATIONS:

  • Extensive knowledge of cGMP regulations as they may be applied in clinical biotechnology manufacturing.
  • Previous experience working in a cGLP regulated industry is a plus.
  • Bachelor's degree (B.A. or B.S.) from four-year college or university
  • 6-8 years related experience, 3+ years in Quality Assurance.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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168) Manager/Sr. Manager, Clinical Contracts and Outsourcing – Full Time Position (San Francisco Bay Area) RY111J

DESCRIPTION:

  • Partner with legal and finance to write, review, amend, negotiate and close contracts
  • Ensure contracts are fair, equitable and enforceable
  • Keep accurate records, meet report deadlines and document significant events
  • Build and develop strong relationships with vendors
  • Prepare RFP, RFI and contract templates
  • Develop and maintain vendor selection documentation and processes
  • Review contract obligations in conjunction with Project management and Clinical Operations staff
  • Notify vendors/partners/subcontractors formally where issues/special circumstances or breaches of contract have taken place
  • Assist and work with senior management on special projects
  • Monitor vendor progress and performance to ensure goods and services
  • Conform to the contract requirements
  • Authorize payments consistent with the contract terms
  • Resolve disputes in a timely manner
  • Prepare and conduct project kick-off meetings, including delivering detailed briefing to the project and accounting teams

EXPERIENCE AND QUALIFICATIONS:

  • Expertise in large, multi-site, clinical trials with multiple vendor types is required.
  • Experience working departments that have established processes in place.
  • Direct experience vetting and negotiating with vendors is a must.
  • Good understanding of the clinical process is important.
  • Budgeting experience
  • Demonstrated capability of managing multiple external vendors for multiple clinical trials simultaneously.
  • Demonstrated leadership qualities, and strong influencing skills.
  • Management experience would be a plus.
  • Knowledge of applicable regulatory and ICH guidance regarding clinical research and GCP.
  • Demonstrated ability to multi-task, prioritize, and independently solve problems in a rapidly changing environment.
  • A strategic thinker who can efficiently utilize company resources and expertise to extract optimal vendor performance.
  • A strong person with the interpersonal skills and credibility, both internally and externally, to successfully negotiate contracts
  • An excellent communicator, both written and verbal, with the ability to train and present data, complex protocol designs etc., and influence internal and external colleagues as required.
  • Excellent organizational skills and attention to detail.
  • An innovative, driven and effective person with a “can do” attitude.
  • A goal-oriented person who can plan for the long-term and execute stated objectives.
  • A flexible individual who can operate comfortably in a rapidly changing and sometimes ambiguous environment.
  • Minimum of a BS degree with clinical contracts experience, global experience a plus. 
  • Experience in clinical finance, business development, or clinical operations would also be considered.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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169) Manager/Senior Manager, Clinical Contracts – Full Time Position (San Francisco Bay Area) C111KP

DESCRIPTION:


  • Available to interact with management and internal clients.
  • Will be a member of the legal team, a tight-knit group of highly-motivated individuals in a positive, professional working environment. 
  • Assist attorneys and team members in the intake, drafting, negotiation and post-execution administration of non-disclosure, material transfer, clinical trial, vendor services, and other agreements. 
  • The successful incumbent must be a self-starter and comfortable working in a fast-paced environment with high volume production requirements, and meeting frequent tight deadlines under minimal supervision. 
  • Manage the process and workflow of contracts, assure compliance with existing agreements, and ensure the proper routing of documents for full execution by corporate officers and outside parties and perform other duties as assigned by attorneys and other team members. 
  • A clinical focus is strongly preferred although there will be overflow work in other business areas.
  • Prepare drafts of agreements and negotiations with outside parties
  • Gather and confirm facts necessary to initiate contract formation with Legal team and internal stakeholders
  • Generate initial contract drafts and prepare successive redlines
  • Perform initial review of contracts and comments from outside parties
  • Negotiation with outside parties
  • Prepare/format and finalize contracts for execution
  • Work with  Legal team to administer a document-tracking database, including data entry and the generation of summary reports on agreement status
  • Monitor contracts for compliance with company and department policies
  • Perform other tasks as assigned by legal team members

EXPERIENCE AND QUALIFICATIONS:

  • The ideal candidate would also have significant experience working on international clinical studies.
  • Familiarity with the clinical study process
  • Excellent communication skills, both written and verbal
  • Excellent organizational and analytical skills
  • Demonstrated proficiency with Microsoft Office applications (Word, Outlook, Excel, Access) and experience with contract management and database applications
  • Flexible team-player with ability to balance multiple projects and instructions often with competing deadlines
  • Creative, self-motivated, self-starter with strong organizational, prioritization and interpersonal skills
  • Excellent skills for negotiating complex contracts with outside parties.
  • BA/BS and relevant industry experience
  • Minimum of three years’ experience in the review, negotiation and administration of clinical contracts (biotech preferred)

To apply for a position send your resume to Jobs@JGBBioPharma.com

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170) Research Associate – Contract (~ 25 hr/wk for 6 mths or longer; San Francisco Bay Area) B999RT

DESCRIPTION:

  • Responsible for research and development in collaboration with others.
  • Normally receives minimal instructions on routine work, and detailed instructions on new assignments.
  • Works on problems of diverse scope w here analysis of data requires evaluation of identifiable factors
  • Exercises judgment within defined practices and policies to select appropriate action for obtaining solutions
  • Is aware of method basic development and limited with good, sound laboratory techniques
  • Effectively communicates questions and issues in meetings
  • Keeps accurate notebook records in accordance with SOP and cGMP requirements
  • Presents work summaries and contributes to the corrections and/or updates of existing written documents
  • Follow s GMP / SOP regulations
  • Informs supervisor and is able to correct simple problems with guidance
  • Maintains accountability for methods, procedures and results
  • Must be able to function in a fast-paced and dynamic environment

EXPERIENCE AND QUALIFICATIONS:

  • Must have experience running HPLC and know Chemstation; Excellent understanding of what chromatograms look like; Good analytical skills
  • Strong communication and technical writing skills
  • Demonstrates effective use of software like Word and Excel
  • Masters or Bachelor’s degree in Chemistry or related field, plus relevant experience one to three (1-3) years working for a pharmaceutical company
  • Background in Analytical Chemistry with applicability to routine testing 

To apply for a position send your resume to Jobs@JGBBioPharma.com

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171) Director / Sr Director Medical Director, Respiratory – Full Time Position (San Francisco Bay Area) Y111AE

DESCRIPTION:

  • Strategic planning of clinical development plans required for evaluating the efficacy and safety of investigational drugs and biologics.  
  • With the assistance of direct reports, management and oversight of Phase 2 trials, leading to Phase 3 trials. 
  • This position reports to the CMO and is a member of the executive staff
  • Supports evaluation of safety data from clinical trials and reports safety findings to regulatory authorities and licensing partners
  • Identifies and maintains liaison with leading investigators in the areas of medicine where products are being developed
  • Reports clinical study findings at professional meetings
  • Identify clinical indications appropriate for investigational drugs

EXPERIENCE AND QUALIFICATIONS:

  • At least 10 years of experience in drug development in the biotechnology or pharmaceutical industry; respiratory experience required.
  • Phase 2 and 3 drug development experience including knowledge of clinical trial design, data interpretation and analysis required
  • Excellent verbal and written communication skills
  • Strong interpersonal skills and ability to work effectively with project teams
  • Management experience
  • Medical Doctor degree, board certified

To apply for a position send your resume to Jobs@JGBBioPharma.com

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172) Senior Medical Director, Drug Safety – Full Time Position (San Francisco Bay Area) MT114A

DESCRIPTION:

Support development programs and post-marketing safety program. Responsible for providing medical guidance, assessment and oversight of any PV/signal detection and risk management on products.  The individual will contribute to set strategies in monitoring and analysis of cumulative safety information in the context of the benefit-risk profile. He or she should be instrumental to effective drug safety crisis management. Responsible for serving as "right hand" for the VP, DSP by preparing analyses and delivering insights; developing presentations; and facilitating strategic meetings. 
Serve as product safety expert and perform surveillance lead responsibilities, including interpretation and evaluation of aggregate adverse event and product complaint data for signal detection, trend analysis, and issue investigations. Demonstrate comprehensive understanding of the safety profile for assigned compounds.   Provide safety strategic guidance to clinical science on safety monitoring.

Job Responsibilities:
  • Effective in building collaborative working relationships within the safety team, functional groups and departments (i.e., Clinical, Regulatory, Quality, Medical Affairs) and corporate partners. 
  • Support VP of Drug Safety Pharmacovigilance on strategic planning and cross functional team programs and departmental initiatives and goals.
  • Timely identification and management of emerging product risks and timely identification of emerging safety issues.
  • Identify important safety issues and analyze pharmacovigilance data for inclusion in reports. 
  • Guidance to safety scientists and safety physicians for aggregate reporting.   Professional knowledge of clinical medicine is essential to sort medical facts in problem analysis and decision analysis.  Initiate and lead clinical interpretation and evaluation of aggregate adverse event and product complaint data.  Lead safety teams or surveillance initiatives to facilitate product safety issues discussion.  
  • Supervise pharmacovigilance personnel (direct reports, consultants and interns), including mentoring, training, and creating an environment for individual growth through problem solving, decision-making, and self-directed learning.
  • Guides regulatory reporting including individual case safety reports (ICSRs), NDA and IND annual report summary statements, and periodic aggregate reports like Periodic Benefit-Risk Evaluation Reports (PBRERs) and Periodic Safety Update Reports (PSURs) *
  • Plans cumulative safety information analyses from company or external databases
  • Demonstrates good understanding of observational studies used in pharmacoepidemiology and ability to provide a sound critique of such studies.
  • Demonstrates proficiency in verbal and email communication, including Microsoft Excel, Word, and Power Point
  • Demonstrates excellent attention to detail, teamwork and initiative; maintains confidentiality; maintains meticulous attention to project deadlines
  • Able to work independently, establishing work priorities and direction
  • Chairs cross functional safety committee meetings (internal or with partner companies); able to present complex information clearly and drive team to effective discussion and resolution.
  • Ensures timely review of protocols, informed consents and other study related documents for multiple products and therapeutic areas
  • Participates on and may lead various cross-functional teams, involving interaction with staff within and external to safety department, to convey and acquire drug safety information internally and externally
  • Directs highly complex communications and ensures that all customers are fully informed and knowledgeable of project activities and their status
  • May conduct and provide oversight of audits/inspections of systems and procedures to ensure the quality, integrity and compliance with pharmacovigilance and safety reporting regulations, including authoring of responses to findings relevant to functional area
  • May participate in budget planning and management

EXPERIENCE AND QUALIFICATIONS:

  • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way. 
  • Leadership in biotech/pharmaceutical organization with direct reports.
  • Must have excellent writing and communication skills
  • Familiarity with common safety databases (e.g. Argus, ArisG) is required
  • Previous experience in scientific /medical writing is desired
  • Product launch experience is desired
  • Ability to read and analyze scientific and medical literature
  • Knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments
  • Working knowledge of MedDRA dictionary
  • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way
  • Epidemiology background is a plus
  • Proficient with Windows:  MS Word, Excel, Power Point and ability to learn new programs as needed
  • Collaborate effectively with the study team, cross-functional team members, and external partners.
  • Must have excellent organizational and problem solving skills
  • Ability to work under pressure and meeting tight timelines
  • M.D., Pharm.D., or Ph.D.
  • Minimum of 7-10 years experience with pharmacovigilance or clinical drug safety including risk/benefit analysis and safety assessment

To apply for a position send your resume to Jobs@JGBBioPharma.com

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173) Drug Safety Scientist – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) E114AX

DESCRIPTION:

Assists and supports the ongoing aggregate review and analysis of product safety for both pre and post-marketing data. Tasks include preparation and authoring of aggregate safety data including signaling analysis, DSUR, PSURs (Periodic Safety Update Reports), Annual Safety Reports, and reports to support internal/external data safety monitoring boards. Collate relevant clinical safety information for safety signal review as guided by the director or manager.  The Scientist will also support other applicable Pharmacovigilance Plans, EU Risk Management Plans, product recalls, and other safety surveillance activities. The Scientist will author and assist in signal evaluations and the management of responses to regulatory agencies related to the assigned product and support query of safety data under the guidance of manager / director.
 
Responsibilities:

  • Use medical background and experience to integrate case-related information including medical conditions, lab results and procedures and effectively identify risk factors
  • Develop and conduct, with supervisory guidance, certain aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests.
  • Extensive medical writing, editing, source document review, and data extraction/verification. 
  • Perform literature search and evaluation
  • Track events of special interest
  • Participate in internal pharmacovigilance committee meetings and joint safety meetings with licensing partners (activities include, but are not limited to, presentation of safety data and taking meeting minutes)
  • Assist in preparation of safety related sections and associated documentation for clinical and regulatory documents (including clinical study protocols, patient informed consent forms, clinical study final reports, IND annual reports, DSUR, PSUR, integrated summaries of safety, RMP and European clinical expert reports)
  • Assist in the creation/revision of department procedures and policies

EXPERIENCE AND QUALIFICATIONS:

  • Strong organizational, teamwork, and interpersonal skills and professionalism required.
  • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way
  • Outstanding communication skills (verbal and written).
  • Focus on detail with enthusiasm to constantly seek ways to improve processes and practices.
  • Ability to manage multiple projects in a fast-paced environment.
  • Collaborate effectively with the study team, cross-functional team members, and external partners.
  • Previous Drug Safety/Pharmacovigilance experience of at least 2 years in a global environment.
  • Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both safety reporting and processing for clinical trial environment as well as post marketing environment
  • Working knowledge of MedDRA dictionary with relevance to SAE analysis and SAE coding.
  • Proficient with Windows: MS Word, Excel, Power Point; and ability to learn new programs as needed.
  • Familiarity with common Safety databases (e.g., Arisg, AERS, Argu) necessary.
  • At a minimum, Bachelor’s level degree in life sciences, pharmacy, or nursing. RN, PharmD or PhD strongly preferred.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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174) Associate Director/Director, Epidemiology – Full Time Position (San Francisco Bay Area) AR114F

DESCRIPTION:

Provide support with expertise in epidemiology, disease and drug registry, and risk management to drug safety and pharmacovigilance, medical affairs and clinical science teams that are developing investigational drugs or marketed products.  Duties include design and analysis of observational studies, registries and post-marketing surveillance and identification of opportunities for population-based disease understanding, safety signal detection, pharmacovigilance, and risk management activities. Interact directly with drug development, medical affairs and post-market program teams to provide deliverables, progress the program, and meet regulatory requirements.

Job Responsibilities:
  • Working as the epidemiology expert for epidemiology within DSP, the person in this position leads epidemiology project activities
  • Provides epidemiology expertise and experience for drug development and marketed products
  • Collaborates with development teams on clinical trial design, safety analysis plans, and the evaluation of safety signals
  • Collaborates with Medical Affairs on disease registries initiatives.  Advise on design of study to gather targeted disease state information and to address population based questions
  • Investigates safety issues related to development projects and marketed drugs
  • Evaluates databases of health insurance claims and/or electronic health/medical records for the feasibility of epidemiologic studies and/or safety surveillance in addressing questions related to drug safety, disease prevalence, risk, and drug utilization and improve company’s knowledge on advanced epidemiologic know how and methodologies.
  • Recommends study design solutions and works with internal or external stakeholders to conduct studies to address compound/drug- specific issues.
  • Collaborates with development teams on clinical trial design, safety analysis plans, and the evaluation of safety signals.
  • Contribute to risk management plans (including REMS) and direct responsibility for executing studies defined as plan deliverables (e.g., registries, drug utilization studies, other observational studies, post marketing safety requirements) and evaluating the effectiveness of the plans.
  • Interact with company management, internal and external key opinion leaders, and regulators as appropriate to successfully conduct epidemiology studies, signal detection and data mining, and risk management.
  • Maintain smooth communication and good relationship with the key stakeholders, Medical Affairs, and Regulatory Affairs to fulfill the needs of development program and the regulatory post-authorization requirements/commitments.

EXPERIENCE AND QUALIFICATIONS:

  • Significant and demonstrable working knowledge of pharmacovigilance regulations and guidelines, including US, ICH and EU regulations. 
  • Demonstrates effective leadership and management skills, including ability to lead and manage a multidisciplinary team of physicians and scientists (including line managers) and ability to navigate joint decisions with business partnerships.
  • Strong organizational, management, teamwork, and interpersonal skills and professionalism required.
  • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.
  • Able to lead meetings, present orally and interact with external bodies
  • Able to work effectively and influence across cultures and functions
  • Proven problem-solving skills and able to work independently
  • Able to manage multiple projects simultaneously and has excellent time management skills
  • Astute observational and analytical skills with a sense of urgency
  • Creative and innovative thinking
  • Able to contribute to strategic decision-making and high-level thinking
  • MPH, PhD in Epidemiology, or Equivalent
  • At least 7 years experience in the health science-related industry with direct exposure to clinical, regulatory or pharmacovigilance functions, including, 5 years epidemiology/pharmacovigilance experience.  
  • Management or team leadership experience essential.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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175) Systems Engineering Manager – Full Time Position (New York) B126XG

DESCRIPTION:

Summary: 
Experience in leading a team of highly skilled systems engineers on complex medical device designs from the conceptual phase through successful product launch. This involves leading the requirements development, systems level architecture design, and interface design definition by collaborating with cross-functional disciplines within the product development environment. His/her team will establish high level product requirements and systems architectures, and will collaborate with department function peers and Project Mangers to create integrated technical designs and project schedules, ensuring that mechanical, electrical, and software subsystems function reliably as one integrated system. Key accountabilities include maintaining the technical competencies of the system engineering team by providing mentoring, training, evaluation, and recruitment.
 
Responsibilities:
  • Facilitate architectural and design decisions to ensure on-time delivery of quality products, within cost, schedule, and performance constraints
  • Lead system engineering processes, in particular establishing design inputs and top down design using various system requirement methodologies
  • Drive hardware and firmware development through the product lifecycle within a stage/phase gate PDP, utilizing risk management techniques and automated requirements traceability tools
  • Ensure team translates market-driven requirements into technical specifications, and ultimately flows them down into lower level hardware and firmware requirement documents
  • Allocate the necessary resources and skill sets to projects ensuring technical, cost, quality, and schedule requirements are met. 
  • Manage resources to meet multiple project needs and objectives. 
  • Gain consensus, lead, influence, and ensure cross-discipline participation and feedback.
  • Work with Project Managers to create and maintain integrated program schedules using advanced scheduling tools and processes such as MS Project, Gantt charts, and WBS
  • Act as technical expert within the system engineering function, advising and coaching subordinates to resolve technical or operational problems
  • Set annual and ongoing goals and objectives for group members. 
  • Write and conduct annual appraisals for group members, actively assessing team’s needs and gaps.
  • Create metrics on tracking design efforts, resources, and effectiveness towards improving product development cycles and quality. Lead functional process and tool improvement initiatives by being early adopter of ideas. 
  • Foster creativity and innovation in design solutions.

EXPERIENCE AND QUALIFICATIONS:

  • Must have experience with digital x-ray equipment technology and imaging science
  • System architecture experience with hardware/software for either medical devices or electro-mechanical devices
  • Experience leading a team in the development of system level product requirements, including high-level system and specific sub-system architectures
  • Successful product lifecycle experience, from the conceptual stage through product launch and into post-launch support.
  • Working knowledge of stage/phase-gate product development process.
  • Able to effectively interface with all project disciplines including Research, Product Development, Service Manufacturing, Regulatory, Marketing, Quality
  • Broad technical experience including electrical, mechanical, and software engineering
  • Experience in the development of processes and procedures which integrate systems engineering and modern design methodologies and associated tools
  • Systematic approach to problem solving and issue resolution combined with good understanding of the relevant technologies and their practical applications
  • Ability to effectively interface with team members in remote locations. 
  • Willing to travel; domestic and international.
  • Develop the skills and abilities of the system engineering function. 
  • Define best-in-class functional processes, standards, and tools. 
  • Conduct ongoing performance benchmarking
  • Strong analytical, problem solving and negotiation skills
  • Self-starter and capable of working with minimal supervision. 
  • Ability to multi-task and provide expertise and leadership across multiple projects.
  • Good oral and written communication skills, especially technical writing
  • Successful product lifecycle experience 
  • Strong technical foundation in engineering design 
  • Strong system architecture, strong system/subsystem integration experience medical devices
  • Strong mix of ME, EE, and SW understanding 
  • Must have X-ray and medical Imaging experience.
  • Strong skills with system/subsystem integration.
  • Strong understanding of HW/SW of electro-mechanical devices.
  • BS or MS degree in Systems, Mechanical, Electrical, Biomedical, or Computer Science. 
  • Strong technical foundation in engineering design principles.
  • Minimum 10 years experience as a Systems Engineer in a regulated industry (i.e. medical, aeronautics, nuclear) developing complex electromechanical systems controlled by embedded/application software
  • Minimum 5 years functional management experience

To apply for a position send your resume to Jobs@JGBBioPharma.com

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176) Sr. Product Manager – Full Time Position (San Francisco Bay Area) P73AG

DESCRIPTION:

Detailed Description

The objective of this position is to develop and manage portfolio of software products and services that provide value added growth for the business segment. This person will develop business cases and own all product management responsibilities for a growing portfolio of software products and services. This person will develop and manage a portfolio of on-market and new software products and services. Will be responsible for development of product definition, positioning, pricing and product lifecycle management. Responsibilities include developing market research, leading product management function in new product development teams, managing inventory, pricing, customer communications, support, and revenue forecasts. This position will manage transitioning of products from standalone desktop software to browser based products along with licensing and commercialization models and will manage maintenance and support plans. This position reports to the Director of IT Solutions Product Management in the Applied Sciences Business Unit.
 
Essential Functions
  • Manage worldwide supply, demand, revenue, margin and pricing for product portfolio; update and present forecasts regularly to management, finance, and manufacturing teams. 
  • Analyze market trends, customer requirements and competitive strategy, and identify opportunities for increasing customer and business value through product differentiation. 
  • Lead new product development process from concept through commercialization, including voice of customer research, definition of customer and product requirements and value proposition, formulating and communicating global launch plans including commercialization strategy, public presentations, competitive analysis, forecasting, positioning and training of internal groups, service, support and sales. 
  • Will lead business aspects of both internally-developed products, as well as those leveraged from external collaborations. 
  • Furthermore, our solutions should represent the best thinking of the pioneers of adjacent industries.
  • Will be a strong leader within cross-functional teams developing the right product to fill market needs, and will serve as the customer advocate interacting w/ functional partners including R&D, Program Management, Manufacturing, Market Development, Finance, Customer Services, Quality and Regulatory Associates. 
  • Will partner closely with the Instrument/Reagent Product Managers and Technical Marketing Specialists to ensure system synergies and optimal customer experiences. 
  • The software strategy will be developed and executed in concert with the centrally managed CIO office- ensuring best practices from one division are shared across all operating groups.
  • Desired applicants should bring specific experiences in building software development communities, designing software and building scalable architectures as well as SDKs. 
  • Some knowledge of Biological sciences and/or genomics is desirable, but not required. An aptitude and interest in learning science including bioinformatics is important. 
  • Candidate must possess a track record of success in driving business innovation, product development, building/leading cross functional teams and effective executive level communication.

EXPERIENCE AND QUALIFICATIONS:

  • Implement business strategy for software, including software as a product or a service
  • Lead product definition teams, defining critical product requirement documents with prioritized features and corresponding business or financial justification with ROI.
  • Understand, follow and be accountable for business aspects of Product Commercialization Process (PCP) for products
  • Assess and evaluate competitive landscape
  • Monetize software through direct and indirect economic business models, segregating differentiated value propositions for customer segments
  • Accurate market analysis, value proposition and forecasting and write business cases communicating global launch plans that include regulatory strategy, reimbursement approach, competitive analysis, forecasting, pricing, positioning and training of internal groups.
  • Set pricing to meet revenue and profitability goals
  • Develop customer oriented sales tools and collateral in partnership with manage total product lifecycle, setting organizational cadence for retirement, refresh or enhancement of existing products- in concert with software engineering organization
  • Contribute globally to the company’s office as part of larger stakeholder community
  • Develop a thorough knowledge of target  customer segments, markets and the competition 
  • Contribute to overarching IT solutions strategy and roadmap

To apply for a position send your resume to Jobs@JGBBioPharma.com

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177) Associate Medical Director, Respiratory – Full Time Position (San Francisco Bay Area) RT111D

DESCRIPTION:

  • Supports the planning and implementation of clinical development plans required for evaluating the efficacy and safety of investigational drugs and biologics.  
  • This position will support the medical monitoring activities and assist Sr. Director, MD, Clinical Development, in the management and oversight of Phase II trials, leading to Phase III trials. 
  • The therapeutic areas of interest include respiratory and oncology.  
  • This position reports to Sr. Director, MD, Clinical Development.
  • Supports medical monitoring efforts in Phase II trials
  • Supports strategic clinical trial input to the clinical operations team
  • Supports investigator selection and evaluations
  • Supports evaluation of safety data from clinical trials and reports safety findings to regulatory authorities and licensing partners
  • Supports writing efforts on clinical study reports
  • Reports status of clinical programs to project teams and management
  • Identifies and maintains liaison with leading investigators in the areas of medicine where products are being developed
  • Reports clinical study findings at professional meetings
  • Assists project teams to identify clinical indications appropriate for investigational drugs

EXPERIENCE AND QUALIFICATIONS:

  • At least two years of experience in drug development in the biotechnology or pharmaceutical industry; respiratory experience desired, but not required.
  • Knowledge of clinical trial design, data interpretation and analysis
  • Ability to analyze, interpret, and report clinical trial findings
  • Effective oral and written communication skills
  • Strong interpersonal skills and ability to work effectively with project teams
  • Medical Doctor degree, board certified

To apply for a position send your resume to Jobs@JGBBioPharma.com

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178) Manager, Drug Safety Science – Full Time Position (San Francisco Bay Area) F114JX

DESCRIPTION:

  • Identify and assist in the management of safety concerns with drug product(s).  
  • Ensure that any safety signals are appropriately evaluated, communicated and managed with guidance from supervisor.  
  • Responsible for writing documents required for assessment & communication of product safety information for core safety documents.   
  • Perform aggregate safety data tabulation and listing compilation.  Able to provide some clinical judgment on safety data review
  • Collaborate with safety physicians, medical monitors, toxicology group, and other functional groups in identification, analysis, and reporting of possible trends or concerns  
  • Contribute to development & maintenance of product safety profile
  • Track events of special interest and assist in development & maintenance of standardized queries for events of special interest
  • Support  the analysis in support of response to regulatory, EC/IRBs and Investigators or ad hoc inquiries regarding safety issues
  • Draft regulatory inquiry responses
  • Provide input and review to key regulatory or clinical documents (i.e. clinical study reports, investigator brochures, integrated summaries of safety, DSUR); may author certain sections as needed under the supervision of the director
  • Perform literature search and review and able to effective determine appropriate and relevant literature for the purpose of safety analysis.
  • Participate in internal pharmacovigilance committee meetings as well as joint safety meetings with licensing partners

EXPERIENCE AND QUALIFICATIONS:


  • Previous experience in scientific /medical writing required
  • Ability to read and collate scientific and medical literature
  • Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both safety reporting and processing for clinical trial environments
  • Working knowledge of MedDRA dictionary
  • Familiarity with common safety databases (e.g. Argus, Aris) is preferred
  • Proficient with Windows: MS Word, Excel, PowerPoint and ability to learn new programs as needed
  • Must have excellent writing and communication skills
  • Collaborate effectively with the study team, cross-functional team members, and external partners.
  • MSc, Pharm.D., Ph.D. preferred
  • Minimum of 3 years experience with pharmacovigilance or clinical safety

To apply for a position send your resume to Jobs@JGBBioPharma.com

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179) Manager / Senior Manager, Drug Safety – Full Time Position (San Francisco Bay Area) H114FZ

DESCRIPTION:

  • Accountable for the day-to-day management and performance of case management team activities. 
  • Responsible for managing all aspects of safety operations by ensuring the accurate and timely collection, recording, evaluation and reporting of adverse events involving clinical trial and post-marketing studies. 
  • implements department policies and operating procedures. Develops systems, tools and processes for drug safety operations. Reviews and approves adverse event analyses and reports prepared by staff for submission to regulatory agencies. Collaborates with clinical teams, regulatory teams, clinical research organizations and corporate partners in the development of safety reporting procedures and post marketing activities. Sets project goals, timelines and resource requirements.  Maintain efficiency of the case management activities. 
  • Ensure that all Safety reports received from any source are processed and reported according to ICH-GCP guidelines, regulatory requirements (of all relevant countries), alliance agreements, and OPs and procedures.
  • Perform, or provide oversight for, all case processing activities including data entry, narrative writing, quality control, and coding of all cases to ensure accuracy, integrity and completeness of information entered in the Safety database.
  • Oversee the set-up of new Safety projects, including updating Safety Management Plans, and development and set-up of study specific Safety systems and processes (as needed).
  • Manage vendor safety reporting activities including site queries, extraction of eCRF information, and quality assurance.
  • Lead, or participate in, safety data analysis and/or procedure development projects to support the Clinical Drug Safety Science group. Participate in the planning and preparation of the adverse event and/or risk sections of protocols, IBs, and ICFs for  studies and review of CRFs (as necessary).
  • Support the Clinical Operation teams with respect to safety related issues as required.
  • Participate in Clinical meetings representing safety.
  • Oversee reconciliation of Safety database with clinical database for a given study.
  • Provide expert guidance on regulations and their impact on safety management processes and procedures.
  • Participate in the development and management of Data Monitoring Committees, including development of charters and ensure that activities/listings for meetings are completed in a timely manner and meeting outcomes are documented as needed for requests from IRBs/IECs and/or regulatory authorities.
  • Develop, manage, and implement departmental safety policies and SOPs.
  • Manage drug safety staff members, as applicable.
  • Performs other duties as requested.

EXPERIENCE AND QUALIFICATIONS:

  • Previous Safety/Pharmacovigilance experience of at least 5 years in a global environment.
  • Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments.
  • Working knowledge of MedDRA dictionary with relevance to SAE analysis and SAE coding.
  • Proficient with Windows: MS Word, Excel, Power Point; and ability to learn new programs as needed.
  • Familiarity with common safety databases (e.g., Arisg, AERS, Argus, etc.) a must.
  • Strong organizational, management, teamwork, and interpersonal skills and professionalism required.
  • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way
  • Outstanding communication skills (verbal and written).
  • Focus on detail with enthusiasm to constantly seek ways to improve processes and practices.
  • Ability to manage multiple projects in a fast-paced environment.
  • Collaborate effectively with the study team, cross-functional team members, and external partners.
  • Education Requirements (degree, certifications, etc.):
  • At a minimum, Bachelor’s level degree in life sciences, pharmacy, nursing or RN. Master’s Degree or PharmD preferred.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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180) Director, Drug Safety & Pharmacovigilance – Full Time Position (San Francisco Bay Area) GB114A

DESCRIPTION:

  • Responsible for the medical oversight of global pharmacovigilance activities of clinical trials and product development. Post-marketing safety experience is highly desirable.
  • Support Safety Operations to establish and maintain policies and procedures for the Clinical Drug Safety Department. 
  • Perform or provide oversight for the medical review of serious adverse event reports to ensure accuracy, integrity and completeness of safety information, and to ensure consistency of medical coding of safety data.
  • Identify and evaluate safety signals through the assessment of single case safety reports and aggregate trend analyses.
  • Ensure ongoing evaluation of the overall safety profile for investigational products, serving as the product safety expert, working in partnership with medical monitors to bring potential safety issues to the attention of the Clinical Team and upper management
  • Support both Clinical Science and Clinical Operations teams with respect to safety related issues as required
  • Provide input and review of responses to regulatory agency questions with regard to safety/ pharmacovigilance activities. 
  • Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, annual reports (DSUR), final study reports, IB, and other documents, as needed.
  • Oversee the activities of both internal safety meetings and external safety meetings with licensing partners (i.e. Joint Safety Management Team meetings). 
  • Collaborate with pharmacovigilance and drug safety colleagues from licensing partners to align on a harmonized approach to identifying, evaluating and communicating safety issues.
  • Support development and maintenance of product benefit-risk profile
  • Manage Drug Safety Science staff members, as applicable.

EXPERIENCE AND QUALIFICATIONS:

  • General knowledge of pharmaceutical development and a minimum of 5 - 7 years of experience in Safety/Pharmacovigilance in a global environment.
  • Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments.
  • Working knowledge of MedDRA dictionary with relevance to SAE analysis and SAE coding.
  • Proficient with Windows: MS Word, Excel, Power Point; and ability to learn new programs as needed. 
  • Familiarity with common Safety databases (e.g., Aris, AERS, Argus, etc.) Argus experience preferred.
  • Strong organizational, management, teamwork, and interpersonal skills and professionalism required.
  • Ability to evaluate and interpret adverse event/serious adverse event reports and other documents to be used in Safety/Pharmacovigilance submissions.
  • Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.
  • Outstanding communication skills (verbal and written).
  • Ability to manage multiple projects in a fast-paced environment.
  • Collaborate effectively with the study team, cross-functional team members, and external partners.
  • M.D.  required

To apply for a position send your resume to Jobs@JGBBioPharma.com

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181) Medical Director – Full Time Position (San Francisco Bay Area) B114TN

DESCRIPTION:

Develops the strategies, designs, implements, monitors and evaluates clinical trials and other associated clinical development programs for assigned molecules or drugs. Medical Director will be assigned responsibilities for Ph II and Ph III clinical trials, programs and/or other projects.  Work closely with internal cross-functional stakeholders, external investigators, various corporate partners and regulatory authorities.

  • Plays a lead role in providing clinical input into the assigned therapeutic areas(s) scientific strategy. Helps Research and to ensure consistency of scientific and development strategies with target label claims and corporate goals. May be called upon to perform clinical assessments on relevant drug discovery projects
  • May also consult to Business Development on relevant acquisitions, joint ventures or other strategic partnerships, as these potentially relate to the assigned therapeutic area(s) product pipeline and portfolio
  • Is responsible for creating the clinical development plan for assigned molecules, drugs and/or other programs
  • Regularly called upon to act as an internal consultant to various internal partners, stakeholders, teams and review or decision-making committees; providing clinical development expertise in relation to assigned therapeutic area(s)
  • Develops and delivers key presentations, both internally and externally, to convey the clinical development perspective and provide updates on activities.  Includes playing a key role in the organization and delivery of successful expert advisory boards
  • Participates in FDA or other health authority interactions with little or no supervision from his/her manager
  • Works with Regulatory and other partners/stakeholders in the completion and submission of IND (investigational new drug) applications and filings.  Supports Regulatory Affairs on clinical development aspects of filings; plays a central role in developing language in a drug’s Package Insert.  Acts as the clinical lead on Filing Teams.  Monitors IND filings for all assigned molecules and programs
  • Provides clinical oversight for a variety of projects:
  • Works with a host of internal and external partners and stakeholders in the design and implementation of clinical trials for assigned molecules and drugs
  • Designs and develops trial protocols; including effectively incorporating cross-functional strategies and input into programs
  • Develops the product safety profile
  • Gains alignment with various internal partners and stakeholders on goals and resource needs.  Includes working with core team project teams to establish appropriate budgets and other resource plans
  • Develops key clinical sections of Investigator brochures
  • Plays a key role in the identification of appropriate external investigators
  • Produces clinical components of presentations at clinical trial investigator meetings; delivering high-quality presentations at such meetings
  • Converts clinical development plans into project implementation plans and leads clinical trial implementation, ongoing monitoring and evaluation, working closely and regularly with external investigators, Clinical Operations and others internally and externally.  Measures project progress, monitors variances and is expected to proactively identify any issues or challenges and develop, recommend and implement strategies to effectively resolve such
  • Plays an important role in the development of disease and/or treatment registries.  Includes developing strategies or plans to enable appropriate registry recruitment
  • Keeps all partners abreast of developments throughout all applicable intervals
  • Contributes to safety and/or other relevant sections of IND annual reports, as these sections and reports relate to assigned molecules and/or drugs
  • May interact with Board of Directors and Investor Relations
  • Works closely with Clinical Operations to  close-out clinical trials and complete internal reporting of  trial status and results; including associated publications


EXPERIENCE AND QUALIFICATIONS:

  • Boarded in hematology or oncology
  • Biotech/pharmaceutical industry experience preferred OR be a recognized expert in the field
  • Strong background/experience with clinical trials (as typically measured by 2 or more years’ experience)
  • Strong, relevant therapeutic experience (as typically measured by 3 or more years’ relevant clinical experience)
  • In-depth understanding and firsthand knowledge of Phase I-III drug development.  
  • Broad experience in the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
  • Demonstrate ever-increasing competence and abilities in leading disease strategy planning and reviews.  
  • Expected to provide important, strategic inputs in Clinical Development decision-making
  • Create targeted and executable clinical development plans for multiple molecules and or drugs
  • Deliver multiple projects and programs on-time, on-target and within-budget
  • Develop and cultivate important relationships with internal and external partners and stakeholders.  Includes developing and cultivating important relationships with thought leaders and KOLs (key opinion leaders)
  • Competently and collaboratively interact with a host of internal and external partners and stakeholders
  • Effectively represent Clinical Science on multi-disciplinary teams.  
  • Stay informed and abreast of the external landscape as it relates to assigned molecules,  drugs and/or programs and the associated therapeutic area(s)
  • Comprehensive understanding of product and safety profiles
  • Well-versed in medical aspects of FDA regulations 

To apply for a position send your resume to Jobs@JGBBioPharma.com

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182) Sr. QA Associate/QA Manager – Full Time Position (San Francisco Bay Area) G104XB

DESCRIPTION:

Provide consultation in the interpretation of GCP regulations, guidelines, policies, and procedures to staff; plan, conduct, and report independent Good Clinical Practice (GCP) Quality Assurance (QA) audits of internal systems/procedures and vendors against applicable regulations and procedures; support, maintain, review QA systems – Controlled Documentation System, Corporate Training program, and Corrective Action and Preventative Actions (CAPAs); and support/provide management with quality metrics and updates.
 
Responsibilities:
  • Manage the QA Document Control system.
  • Assist in SOP writing and/or review.
  • Assist in preparing and hosting Client audits 
  • Write/review/track CAPAs for audits.
  • Conduct audits (internal systems and vendor) 
  • Provide QA/compliance advice to staff.
  • Perform other related duties as assigned.

EXPERIENCE AND QUALIFICATIONS:

  • Strong knowledge of FDA GCP and ICH regulations, guidelines, and standards governing regulated clinical research is required.
  • Working knowledge and understanding of drug development and global clinical regulatory environment.
  • Outstanding interpersonal, oral and written communication skills.
  • Detail oriented.
  • Available to travel 10% of the time.
  • Bachelor's degree in scientific or related discipline, or equivalent work experience.
  • Minimum of 5-7 years industry experience, with at least 3-5 years in clinical QA.
  • Direct experience with internal/external clinical systems and process audits.
  • Experience in QA audits of Clinical Investigators and Clinical Vendors.
  • Experience in development of SOPs.
  • Strong software and computer skills; including MS Word, Excel, PowerPoint, and Outlook. Excellent presentation skills.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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183) Senior SCRA to Clinical Program Manager Level – Full Time Position (San Francisco Bay Area) W111HL

DESCRIPTION:

  • Reports to Sr. Director Clinical Operations; position initially has no direct reports but may within a year
  • Manage Phase 2A to 2/3 oncology program including CRO’s and vendors to ensure that the study(ies) are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines
  • Works closely and independently with the CMO and Medical Directors and represents clinical operations for this program

EXPERIENCE AND QUALIFICATIONS:


  • Experience in Oncology required
  • Must be hands on and used to a start-up environment
  • Knowledge of GCP and ICH guidelines required
  • Proficiency in the implementation, monitoring, and management of clinical trials
  • Able to work collegially within a team and carry out duties/responsibilities with general instructions
  • Proficiency with MS Word, Excel, Outlook, PowerPoint and Microsoft Project
  • Must be willing to travel occasionally (this is an in-house position so very little travel is required)
  • Previous experience as with minimum title of SCRA
  • Study start-up experience is required
  • Global trial experience is desirable
  • Demonstrated stellar track record in the oversight of all trial operational aspects including: budgets, timelines, resources, vendor selection and oversight of clinical team staff during study start-up, interim monitoring and closeout activities.
  • Bachelor’s degree in a relevant scientific discipline or equivalent
  • At least 4 years of relevant clinical experience in the pharmaceutical industry or equivalent (SCRA) and minimum of 7 years for Clinical Program Manager title. 
  • Must have 3+ years as a CRA in biotech or Pharmaceutical clinical operations (not a device or diagnostics company) environment
  • Basic relocation provided

To apply for a position send your resume to Jobs@JGBBioPharma.com

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184) Sr. Manager Training – Full Time Position (San Francisco Bay Area) T114GR

DESCRIPTION:

Responsible for monitoring the effectiveness of the training program and maintaining compliance with policies, procedures, and applicable GXP regulations.

Key Accountabilities/Core Job Responsibilities:
  • Manage and develop the training department staff.  Mentor staff for individual growth, process efficiency and effective performance.
  • Interact with department management and training representatives to develop training curricula specific to department needs and ensure that department staff are effectively trained on corporate policies, department processes, GxP procedures, and regulatory requirements.
  • Develop processes and tools for the evaluation of training courses, testing and other processes to ensure the effectiveness of the learning and development activities. 
  • Develop training metrics to optimize the performance of the training system to ensure productivity and effective 
  • Maintain a consultative relationship with department training coordinators and with subject-matter experts to enhance the delivery of training content and to identify opportunities for training program improvement.
  • Manage and maintain the ongoing GXP refresher-training program.  
  • Ensure that GXP employees are provided with current GXP training content on a scheduled basis, schedule GXP training on a defined yearly schedule, and track GXP refresher training completion.
  • Acquire and maintain in depth knowledge of GXP compliance trends in order to develop strategies for the delivery of high quality training courses that are relevant to the needs of the organization.
  • Serve as the subject matter expert for training in support of partner and regulatory agency inspections.

EXPERIENCE AND QUALIFICATIONS:

  • Experience developing and implementing course assessments, testing and other processes to ensure the effectiveness of the learning and development activities.
  • Must have an understanding and application of GXPs in the development, clinical, and commercial area of pharmaceuticals products.
  • Knowledge and understanding of the current pharmaceutical industry and applicable domestic and international regulations.
  • The ability to work with subject matter experts to develop and present diverse training topics.
  • BS/BA degree or equivalent and a minimum of 6 years of related experience
  • Minimum of five years experience leading training initiatives and programs for an organization. 
  • Previous training experience in the biotech or pharmaceutical industry highly desirable.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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185) Manager, Quality Assurance – Full Time Position (San Francisco Bay Area) D114QF

DESCRIPTION:

Establishes and maintains QA programs, systems, policies, processes, procedures and controls as they relate to the manufacture, analytical testing, and material disposition of clinical drug substances and drug products manufactured at CMOs.
 
Key Accountabilities/Core Job Responsibilities:
  • Manages all documents received from CMOs through document change control and archival process, as required by internal procedures
  • Independently reviews and approves master batch records, labels, specifications, and other manufacturing documents of drug substance and drug products under clinical development in compliance with US FDA and international health agency requirements.
  • Independently reviews and approves executed manufacturing batch records, analytical data, and associated documentation, including any deviations and investigation reports related to material disposition.
  • Assists with quality investigations and CAPA recommendations related to manufactured products.
  • Manages the clinical product disposition process to ensure quality review and release of clinical products in accordance with domestic and international regulations.
  • Reviews and approves change control requests to ensure compliance with company procedures, cGMP, and other applicable regulations.
  • Represents QA and provides support to the internal CMC team.
  • Provides and prepares quality metrics as needed.
  • Initiate updates and creation of new SOPs as required.
  • Serves as Quality Representative for regulatory inspections as needed.

EXPERIENCE AND QUALIFICATIONS:

  • Excellent working knowledge and understanding of GMP related requirements, proficiency of regulatory and ICH guidelines. 
  • Broad experience in the pharmaceutical industry with a strong analytical and/or manufacturing background, some R & D a plus.
  • Detail oriented with Quality Assurance background with solid problem solving acumen. 
  • Ability to work effectively in a team environment with great organization skills.
  • Excellent working knowledge of Quality Systems and cGMP standards applicable to clinical trial materials.
  • Ability to analyze and reconcile moderate to complex issues independently.
  • Must be an individual with proven initiative and demonstrated accountability in a fast paced environment.
  • Excellent verbal and written communication and interpersonal skills.
  • Proficient with computers and word processing software (i.e. Microsoft Office products
  • Minimum BA/BS Degree in biological sciences, chemistry, or related field.
  • 9+ years of relative progressive cGMP biotech or pharmaceutical manufacturing environment experience and 6-8 years of operational quality experience executing, developing, and administrating Quality Systems.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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186) Software Quality Engineer – Full Time (Midwest) RG73B

DESCRIPTION:

  • Responsible for ensuring end-to-end quality across a variety of software and data products. Includes functional testing, regression testing, and performance testing it also goes well beyond tests to advocating on behalf of customers, mitigating risks, and promoting best practices  - all while focusing on the big picture and keeping the mission in mind. Immense creativity and a passion for product excellence are expected
  • Define, launch, and enforce best practice processes that promote traceability, reliability, operability, and efficiency in the software delivery process. Mentor and coach a broad mix of technical and non-technical colleagues on these practices. Evangelize verification and validation.
  • Work closely with User Experience, Product Management, and other stakeholders to decipher product requirements, proactively identify product improvements, and push product designs toward quality.
  • Collaborate with engineering teams during product development to document and address quality issues. Review and approve user story cards. Help stakeholders prioritize defects.
  • Lead and execute product testing including development of overall strategies, establishment of performance baselines, capacity forecasting, test automation, tool assessment, and reporting mechanisms.
  • Develop expertise in the company products, software tools, and development processes, using that expertise to identify weaknesses and advocate for quality on behalf of customers.
  • Plan and coordinate release-specific testing efforts with Program/Product management and Scientific QA.

EXPERIENCE AND QUALIFICATIONS:

  • Capable of seeing the forest among the trees, focusing on quality product deliverables, customer satisfaction, and overall testing strategies
  • Strong understanding of testing, tuning exceeding customer expectations of quality.
  • Demonstrated understanding of quality concerns, user-centered design, and software verification and validation techniques.
  • General understanding of the modern software development landscape including cloud computing, architecture stacks, and data storage mechanisms.
  • Acquainted with Selenium, JUnit, and other testing frameworks.
  • Experience leading the evolution from manual testing scripts to automated testing suites.
  • Comfortable working in a fast-paced, dynamic, discovery-oriented environment.
  • Excellent verbal and written communication skills
  • Experience working in an Agile or Scrum environment – preferred, but not required.
  • Experience working in a regulated environment – preferred, but not required.
  • Ability to code in Java (or similar OO language) and SQL as needed for testing – Preferred, but not required.
  • Preferred, not required, background in a scientific, data-oriented domain
  • ISO 9000 training – Preferred, but not required.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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187) Senior Clinical Research Associate – Full Time Position (San Francisco Bay Area) F114NB

DESCRIPTION:

Description

Responsible for implementing set-up, execution, oversight and reporting of clinical studies while ensuring that the conduct of the trial is in compliance with the protocol, ICH/GCP, and applicable regulatory requirements.
 
Key Accountabilities/Core Job Responsibilities:
  • Lead multifunctional team through clinical studies activities that meet ICH/GCP and SOP requirements
  • Develop clinical trial protocol synopsis, protocols, amendments and informed consent documents
  • Develop study budget and timelines
  • Prepare regulatory documents and submissions
  • Execute project specific training for internal and external staff
  • Maintain Trial Master File
  • Manage Investigational Product (IP)
  • Manage safety reporting
  • Procure and manage contracts with CROs, study vendors and investigative sites
  • Provide oversight of CROs, independent field monitors and other clinical vendors
  • Review monitoring trip reports and track resolution of all action items
  • Co-monitor at investigative sites to evaluate study site and field monitor performance
  • Collaborate with medical experts, clinical study sites, and clinical study vendors
  • Performs  in-house review of clinical database listings for completeness and accuracy
  • Develops clinical study reports

EXPERIENCE AND QUALIFICATIONS:

  • Excellent verbal and written communication skills
  • Attention to detail
  • Able to organize, manage and set priorities for multiple tasks
  • Strong leadership skills, self-motivated, adaptable to a dynamic environment
  • Able to collaborate effectively with the study team, cross-functional team members, and external partners
  • Knowledge of ICH/GCP and FDA regulations
  • Proficiency in MS Word, Excel and Powerpoint
  • Able and willing to travel approximately 25-30%   
  • 6+ years of relevant clinical experience in a CRO, pharmaceutical, or biotechnology company (including on-site monitoring experience) 
  • Experience in oncology preferred
  • Experience in global trials preferred
  • Experience with Electronic Data Capture systems preferred 
  • BS/BA degree in a life science, RN, or related field

To apply for a position send your resume to Jobs@JGBBioPharma.com

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188) Statistical Programmer III – Full Time Position (San Francisco Bay Area) B114NG

DESCRIPTION:

Designs, develops, evaluates and modifies computer programs to analyze and evaluate clinical data. Generate Study specific and ad-hoc clinical data listings, summary tables and figures.
 
Key Accountabilities/Core Job Responsibilities:
  • Performs data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data.
  • Create CDISC SDTM and ADaM files and SAS export files to use for Electronic Submission from the data received in non-standard form from various sources.
  • Performs Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
  • Review Data Management Plan, Data validation plan and edit check specifications
  • Interact with Statisticians and other clinical team, perform ad hoc analysis and generate outputs according to the requirements.
  • Recognizes inconsistencies and initiates resolution of data problems.
  • Acts as a liaison between statistical programming, subcommittees and project teams as needed. 
  • Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
  • Works on significant and unique issues where analysis of situations or data requires evaluation of intangibles.
  • Acts independently to determine methods and procedures on new assignments.
  • May provide guidance to other lower level personnel.
  • Support lead programmer in generation of analysis datasets, generation of TLFs (Tables, Listings, and Figures), validation of aforementioned data and reports, and maintenance of study documentation
  • Generate and QC summary tables, data listings and figures for in-house analyses of study data or publications using SAS standard coding practices.
  • Validate work of other programmer/analysts at CRO or in-house.
  • Maintain complete and auditable documentation of all programming activities.

EXPERIENCE AND QUALIFICATIONS:

  • Ability to use professional concepts to achieve objectives in creative and effective ways.
  • Experience in the analysis of Oncology clinical trial data a plus.
  • Knowledge of CDISC standard (SDTM & ADaM) a plus.
  • Minimum 5 years Pharmaceutical/Biotech programming experience.
  • NDA submission experience is a plus
  • Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
  • BS in Statistics, Math or Scientific Discipline.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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189) Principal Statistical Analyst/ Senior Manager, Statistical Programming – Full Time Position (San Francisco Bay Area) G114RF

DESCRIPTION:

Designs, develops, evaluates and modifies computer programs to analyze and evaluate clinical data. Generate Study specific and ad-hoc clinical data listings, summary tables and figures.
 
Key Accountabilities/Core Job Responsibilities:
  • Project lead level activities.
  • Performs data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data.
  • Create CDISC SDTM and ADaM files, SAS export files and Define.xml use for Electronic Submission from the data received in non-standard form from various sources.
  • Performs Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
  • Review Data Management Plan, Data validation plan and edit check specifications
  • Interact with Statisticians and other clinical team, perform ad hoc analysis and generate outputs according to the requirements.
  • Implements and contributes to statistical analysis plans; provides additional expertise in the analysis of clinical trial as it relates to protocol development, case report form design and data collection. 
  • Recognizes inconsistencies and initiates resolution of data problems.
  • Acts as a liaison between statistical programming, subcommittees and project teams as needed. 
  • Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
  • Works on significant and unique issues where analysis of situations or data requires evaluation of intangibles.
  • Acts independently to determine methods and procedures on new assignments.
  • May provide guidance to other lower level personnel.
  • Works closely with Biostatistics to create analysis files specifications following the instructions provided in Statistical Analysis Plan (SAP)
  • Develop SAS coding and table templates for preparing, processing and analyzing clinical data.
  • Create/acquire tools to improve programming efficiency or quality.
  • Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.
  • Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.

EXPERIENCE AND QUALIFICATIONS:

  • Ability to use professional concepts to achieve objectives in creative and effective ways.
  • Experience in the analysis of complex Oncology clinical trial data.
  • Experienced in supervising and mentoring programming staff.
  • Solid knowledge of CDISC standard (SDTM & ADaM).
  • Minimum 12 years Pharmaceutical/Biotech programming experience.
  • NDA submission experience and knowledge required.
  • Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
  • BS/MS in Statistics, Math or Scientific Discipline.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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190) Senior Biostatistician – Full Time Position (San Francisco Bay Area) B114MT

DESCRIPTION:

  • Collaboration with clinical scientists on protocol design (author statistical methods section and generate study randomization)
  • Generate statistical analysis plan for assigned protocols (incl. Mock displays)
  • Assume responsibility for individual studies, write statistical portion of integrated clinical/statistical reports
  • Work with SAS programmer to develop statistical programs to perform analysis, prepare data displays, verify data accuracy and validity
  • Supply statistical input for NDA submissions and in response to FDA queries
  • Provide support for investigator publications
  • Review case report forms, data management plan, and monitoring plan to ensure that protocol objectives are met and project standards are maintained

EXPERIENCE AND QUALIFICATIONS:

  • Demonstrated sound knowledge of applied statistics and biostatistics and relevant experience in the application of statistics to medical trials. 
  • Experience with SAS. 
  • Strong interpersonal and effective communication skills
  • Pharmaceutical industry experience required. 
  • NDA submission experience required. 
  • Global submission experience is a plus
  • Education Requirements (degree, certifications, etc.):
  • Ph.D. in Biostatistics or closely related discipline with a minimum of 8 years experience in pharmaceutical and biotech industry.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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191) Corporate Paralegal – Full Time Position (San Francisco Bay Area) T111KX

DESCRIPTION:

  • The ideal candidate will have significant experience working on one or more initial public offerings.
  • Prepare board of director and stockholder resolutions, and corporate filings
  • Prepare and oversee required corporate filings
  • Assist with board and stockholder matters
  • Assist with corporate secretary responsibilities for foreign subsidiaries
  • Maintain and organize good corporate books and records
  • Work with multiple departments including finance and tax
  • Participate in the development/review of department forms and procedures
  • Perform other tasks and special projects
  • Assist in preparation and filing of periodic SEC reports (e.g., 10-Qs, 10-Ks, 8-Ks, etc.)
  • Assist with other corporate and securities compliance matters
  • Prepare, process, and manage Section 16 filings for directors and officers
  • Assist with all aspects of corporate transactions including financings and corporate partnering deals.

EXPERIENCE AND QUALIFICATIONS:

  • Paralegal with SEC/IPO experience
  • Excellent organizational and analytical skills
  • Public company experience, including working on public offerings
  • Flexible team-player with excellent interpersonal and communication skills, both written and verbal
  • Demonstrated ability to balance multiple projects, often with competing deadlines
  • Experience leading projects and ensuring on-time and successful completion of tasks
  • Proficiency with Microsoft Office applications, including Excel and Word
  • Project and process management skills
  • Discretion, sound judgment, tact and diplomacy in all communications
  • Strong preference for well-organized, self-assured, self-starters willing to work irregular hours when needed
  • Contracts drafting and negotiation experience is a strong plus
  • Mandarin helpful but not required
  • BA/BS and/or ABA-approved paralegal certificate, or other comparable legal experience

To apply for a position send your resume to Jobs@JGBBioPharma.com

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192) Clinical Contracts Administrator / Paralegal – Full Time Position (San Francisco Bay Area) GY111P

DESCRIPTION:

  • Experience working on clinical contracts in the biotech/pharma setting and significant experience working on international clinical studies.
  • Assist attorneys and team members in the intake, drafting, negotiation and post-execution administration of non-disclosure, material transfer, clinical trial, vendor services, and other agreements. 
  • Must be a self-starter and comfortable working in a fast-paced environment with high volume production requirements, and meeting frequent tight deadlines under minimal supervision. 
  • Manage the process and workflow of contracts, assure compliance with existing agreements, and ensure the proper routing of documents for full execution by corporate officers and outside parties and perform other duties as assigned by 
  • attorneys and other team members. 
  • Prepare drafts of agreements and negotiations with outside parties
  • Gather and confirm facts necessary to initiate contract formation with  Legal team and internal stakeholders
  • Generate initial contract drafts and prepare successive redlines
  • Perform initial review of contracts and comments from outside parties
  • Negotiation with outside parties
  • Prepare/format and finalize contracts for execution
  • Work with the Legal team to administer a document-tracking database, including data entry and the generation of summary reports on agreement status
  • Monitor contracts for compliance with company and department policies
  • Perform other tasks as assigned by the Legal team members

EXPERIENCE AND QUALIFICATIONS:

  • Minimum of three years’ experience in the review, negotiation and administration of clinical contracts (biotech preferred)
  • Familiarity with the clinical study process
  • Intellectual property law background preferred
  • Excellent communication skills, both written and verbal
  • Excellent organizational and analytical skills
  • Demonstrated proficiency with Microsoft Office applications (Word, Outlook, Excel, Access) and experience with contract management and database applications
  • Flexible team-player with ability to balance multiple projects and instructions often with competing deadlines
  • Creative, self-motivated, self-starter with strong organizational, prioritization and interpersonal skills
  • BA/BS and/or ABA-approved paralegal certificate, or other comparable legal experience

To apply for a position send your resume to Jobs@JGBBioPharma.com

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193) Senior Manager, Clinical GCP Document Control – Full Time Position (San Francisco Bay Area) MT114R

DESCRIPTION:

This position reports to the Clinical Operations department and has overall responsibility for developing, implementing, managing and maintaining Clinical Trial Master File (CTMF) systems according to FDA GCP requirements, ICH GCP requirements and typical pharmaceutical and biotech industry practices.
 
Key Accountabilities/Core Job Responsibilities:

  • Develops and oversees CTMF document control policies, procedures, processes and systems in accordance with all applicable regulatory requirements and established  procedures and policies.
  • Develops document management systems to meet the needs of the Clinical Development department, including paper-based CTMF storage and maintenance systems, as well as electronic CTMF systems (eCTMF).
  • Develops, implements and maintains CTMFs for all clinical trials.
  • Interacts with Clinical Development department staff and relevant cross-functional departments to establish priorities and deadlines for processing and filing of CTMF required documents.
  • Ensures all required CTMF documents are filed, tracked, maintained, and archived in accordance with regulatory requirements and  procedures and processes.
  • Manages and controls the paper-based CTMF storage room and its contents.
  • Manages and controls the eCTMF storage and maintenance systems.
  • Creates systems to ensure that CTMF documents are filed correctly, easily retrievable, and maintained in accordance with all applicable regulatory requirements and  procedures and processes.
  • Develops and manages the archiving systems and retrieval of archived CTMF documents.
  • Functions as the Subject Matter Expert for CTMF document management systems and processes within
  • Provides CTMF support and guidance for internal and external CTMF audits.
  • Provides CTMF support and guidance for US and Ex-US regulatory authority inspections.

EXPERIENCE AND QUALIFICATIONS:

  • Excellent working knowledge of current paper-based CTMF systems and standards and GCPs.
  • Excellent working knowledge of current electronic CTMF systems and standards.
  • Ability to analyze and reconcile complex issues independently.
  • Ability to independently and effectively manage assigned task and projects.
  • Ability to lead and manage CTMF support personnel.
  • Ability to develop or update Standard Operating Procedures and Work Instructions.
  • Excellent verbal and written communication and interpersonal skills.
  • Must be an individual with proven initiative and demonstrated ability in a fast paced environment
  • Established experience and knowledge of general CTMF systems and standards.
  • Established experience and knowledge of paper-based document CTMF systems.
  • Established experience and knowledge of electronic CTMF systems.
  • Established experience providing CTMF support for US and Ex-US regulatory authority inspections
  • Demonstrated knowledge of US and Ex-US regulatory authority CTMF requirements.
  • Proficient in creation of document tracking systems and use of Adobe Acrobat and MS Office Suite.
  • Established experience with design, development and implementation of a paper-based CTMF storage room.
  • Established experience with identification, selection, implementation and maintenance of an electronic CTMF system.
  • Established understanding and experience with Web-based applications for controlled document indexing, tracking and viewing.
  • Must have Bachelor’s Degree or equivalent with a minimum of 8 years of relevant pharmaceutical or biotech CTMF development and management experience, or equivalent experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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194) Senior Manager, Clinical GCP Document Control – Full Time Position (San Francisco Bay Area) MT114R

DESCRIPTION:

This position reports to the Clinical Operations department and has overall responsibility for developing, implementing, managing and maintaining Clinical Trial Master File (CTMF) systems according to FDA GCP requirements, ICH GCP requirements and typical pharmaceutical and biotech industry practices.
 
Key Accountabilities/Core Job Responsibilities:
  • Develops and oversees CTMF document control policies, procedures, processes and systems in accordance with all applicable regulatory requirements and established  procedures and policies.
  • Develops document management systems to meet the needs of the Clinical Development department, including paper-based CTMF storage and maintenance systems, as well as electronic CTMF systems (eCTMF).
  • Develops, implements and maintains CTMFs for all clinical trials.
  • Interacts with Clinical Development department staff and relevant cross-functional departments to establish priorities and deadlines for processing and filing of CTMF required documents.
  • Ensures all required CTMF documents are filed, tracked, maintained, and archived in accordance with regulatory requirements and  procedures and processes.
  • Manages and controls the paper-based CTMF storage room and its contents.
  • Manages and controls the eCTMF storage and maintenance systems.
  • Creates systems to ensure that CTMF documents are filed correctly, easily retrievable, and maintained in accordance with all applicable regulatory requirements and  procedures and processes.
  • Develops and manages the archiving systems and retrieval of archived CTMF documents.
  • Functions as the Subject Matter Expert for CTMF document management systems and processes within
  • Provides CTMF support and guidance for internal and external CTMF audits.
  • Provides CTMF support and guidance for US and Ex-US regulatory authority inspections.

EXPERIENCE AND QUALIFICATIONS:

  • Excellent working knowledge of current paper-based CTMF systems and standards and GCPs.
  • Excellent working knowledge of current electronic CTMF systems and standards.
  • Ability to analyze and reconcile complex issues independently.
  • Ability to independently and effectively manage assigned task and projects.
  • Ability to lead and manage CTMF support personnel.
  • Ability to develop or update Standard Operating Procedures and Work Instructions.
  • Excellent verbal and written communication and interpersonal skills.
  • Must be an individual with proven initiative and demonstrated ability in a fast paced environment
  • Established experience and knowledge of general CTMF systems and standards.
  • Established experience and knowledge of paper-based document CTMF systems.
  • Established experience and knowledge of electronic CTMF systems.
  •  Established experience providing CTMF support for US and Ex-US regulatory authority inspections
  • Demonstrated knowledge of US and Ex-US regulatory authority CTMF requirements.
  • Proficient in creation of document tracking systems and use of Adobe Acrobat and MS Office Suite.
  • Established experience with design, development and implementation of a paper-based CTMF storage room.
  • Established experience with identification, selection, implementation and maintenance of an electronic CTMF system.
  • Established understanding and experience with Web-based applications for controlled document indexing, tracking and viewing.
  • Must have Bachelor’s Degree or equivalent with a minimum of 8 years of relevant pharmaceutical or biotech CTMF development and management experience, or equivalent experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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195) Director, Statistical Programming – Full Time Position (San Francisco Bay Area) X111JP

DESCRIPTION:

  • Lead the statistical programming activities for multiple compounds and will lead the programming submission related activities. 
  • Establish standards for programming and efficiency within the group.
  • Manages a team of statistical programmers.
  • Identifies new tools to increase group productivity.
  • Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures.
  • Provides primary and secondary programming support as needed and harmonizes strategic initiatives (e.g., process improvement) across a therapeutic area or equivalent. 
  • Excellent verbal and written communication skills and interpersonal skills are required.Has understanding of the business beyond the functional area.
  • Capable of recommending new operating procedures as appropriate and determining if the analysis infrastructure needs changes to improve efficiency and minimize errors.
  • Must be able to lead strategic initiatives for the statistical programming group.
  • Represents the statistical programming group at project team meetings.
  • Has the proven ability to directly supervise personnel.

EXPERIENCE AND QUALIFICATIONS:


  • Submission, ISS, and ISE expertise
  • Leadership skills
  • Experience in multiple therapeutic areas is desired
  • Experience in clinical development statistical programming methods and processes in industry setting required
  • Experience in direct management of statistical programmers
  • Experience and in-depth knowledge in CDISC including SDTM, ADaM, Metadata, and controlled terminologies
  • Enable to establish process and develop utilities efficiently for different versions of Implementation Guides and Standards. Enable to assess the impact of procedural or system changes , and develop/implement strategies to maintain consistency of programming
  • Knowledge of SOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application
  • Good presentation, oral and written communication skills, including a customer base focus, a commitment to quality management, and problem solving experience. 
  • 11 years of experience and a BS degree in Biostatistics/Computer Science or equivalent, or 7 years of experience and a MS degree in Biostatistics/Computer Science or equivalent, or 5 years of experience and a PhD degree in Biostatistics/Computer Sciences or equivalent.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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196) IVD Systems & Verification Engineer – Full Time Position (San Francisco Bay Area) B118HZ

DESCRIPTION:

  • Work closely with marketing to develop product requirements. 
  • Work closely with other senior technical staff to identify the key technical challenges to meeting said requirements, and develop system architectures for IVD products.  
  • Improve on the process for system and sub-system verification, including test automation and traceability to requirements, specifications and risk. Partake in verification and validation testing as needed. These responsibilities also apply to integration testing. 
  • Perform system level modeling to determine power consumption, throughput/speed, cost, etc.,  for complex IVD products.
  • Perform risk analysis, compliant to relevant international standards, for products in development.  
  • Some lab work with blood based in vitro diagnostics. 
  • Support activities and processes in compliance with applicable international standards and FDA guidelines.

EXPERIENCE AND QUALIFICATIONS:

  • Travel requirements: up to 10%. 
  • Experience with Regulatory requirements for IVD products
  • Experience with SysML and/or UML, Fluidic and electromechanical systems  
  • Experience with MATLAB/Simulink
  • Experience with Code development in one or more of the following: C#, C, Python
  • Experience with DOE, Statistics, and associated tools
  • Good written and oral communication skills are a must.
  • At least eight years overall engineering experience, with at least five years in the medical device or diagnostics industry, or other highly regulated industry (e.g., aerospace, automotive), including one or more successful product launch.
  • Direct experience in test automation, and generally improving the process of verification.
  • Direct experience solving complex system engineering issues, including the interaction of the instrument, assay and consumables, and user.
  • Direct experience working with marketing in the product definition stage, and continuing to the successful verification and validation of a product.
  • BS in Electrical, Mechanical, or Biomedical Engineering. M.S. or Ph.D. is preferred.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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197) Senior QA Specialist, Manager – Contract to Full Time (San Francisco Bay Area) BK106P

DESCRIPTION:

  • Ensure that product and process changes are properly qualified prior to becoming effective. 
  • Review validation activities (IQ/OQ/PQ) including protocols and final reports related to manufacturing processes including inspection equipment and analytical test methods.
  • Establish and manage the design and development process.
  • Manage product risk management file updates, risk assessments to support complaints, CAPAs, and related product risk assessments.
  • Perform training to support compliance to internal procedures and external regulations.
  • Develop and enhance measurement, inspection and test systems for existing products and processes. 
  • Maintain and develop quality assurance inspection and test procedures and work instructions.
  • Coordinate and perform audits of both internal and external operations.  
  • Identify compliance risks and report findings to appropriate management with recommendations for resolution.
  • Design History Record/Batch record review and product release including review of analytical test data.
  • Establish and maintain quality engineering methodologies such as design control, change control, quality planning, complaint handling, auditing, CAPA and supplier management. 
  • Provide quality engineering support/product risk management and technical problem-solving.
  • Review and approval of facility, equipment and manufacturing process/change control documentation.

EXPERIENCE AND QUALIFICATIONS:


  • Strong knowledge of drug cGMP (21 CFR Parts 210, 211 and 820); Knowledge of device or combination product highly desierable
  • Excellent written and verbal communication skills.
  • Experience with analytical and statistical techniques such as DOE.
  • Ability to critically evaluate and troubleshoot complex problems is essential. 
  • Must take initiative and be solution oriented.
  • Must be able to work in a team oriented, fast paced environment with multiple priorities.
  • Minimum 5+ years in drug delivery or combination (drug/device) products.
  • BA/BS Degree in scientific discipline.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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198) Sr. Database Developer (Software Engineering III) – Two Full Time Positions (Midwest) G73RP

DESCRIPTION:

Description:
There are 2 positions, one with more validation and verification. The purpose of the Database Developer is to apply best-practices of engineering disciplines to the management of large amounts of complex data, and to provide oversight and leadership to the Development Team. The emphasis is on data analysis, data integration, systems integration, and system administration but this position will also have some software development.  The technical challenge is natural language processing, big data analysis, requirement identification, prototyping, design and implementation through to customer acceptance. 

Essential Functions:
  • Use prior knowledge and experience to provide functional support and leadership to colleagues
  • Responsible for initial design and development of new database, software and/or extensive revisions.
  • Define technical requirements and create high-level architectural specifications, ensuring feasibility, functionality, and integration with existing systems/platforms
  • Demonstrate expertise in a variety of the field's concepts, practices, and procedures. Rely on extensive experience and judgment to understand complex problems and resolve them efficiently
  • Participate in training and orienting new engineers as they join the team
  • Manage the care and feeding of large and complex data stores serving multiple internal and external consumers
  • Transition R & D reference bioinformatics methods/implementations into operational offerings
  • Integrate third-party database, data transformation, and data visualization systems
  • Design, build, and maintain internal tools to support data curation and ongoing research
  • Maintain existing suite of customer-facing solutions including substantial system and database administration

EXPERIENCE AND QUALIFICATIONS:

  • Skilled in SQL and object-oriented programming (Java preferred, but Ruby, Python, C++, etc. considered) including common data structures
  • Prior exposure to scripting languages (e.g. Perl, Bash), Linux, and web development
  • Data storage and management expertise using a variety of traditional (Oracle, MySQL) and non-traditional “big data” technologies (MongoDB, CouchDB, Cassandra, Neo4j)
  • Experience with data modeling, data integration, data analysis, data mining, database design, and ETL technologies
  • Comfortable with or willing to learn a variety of system administration tasks (command-line interfaces, Linux, yum, CPAN, networking and firewalls, etc.)
  • Values simplicity in software architecture, design, and practices (DTSTTCPW, YAGNI, refactor ruthlessly)
  • Has proven experience with testing and testability
  • Masters and/or Ph.D degree and/or minimum 6 years work experience in related fields.
  • Experience in natural language processing – Preferred, but not required.
  • Experience interacting with semantic web ontologies (OWL, RDF) – Preferred, but not required.
  • Experience working in an Agile or Scrum environment – Preferred, but not required.
  • Experience working in a regulated health sciences related environment – Preferred, but not required.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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199) SCRA / Clinical Trial Manager – Contract or Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) JX111Q

DESCRIPTION:

  • Manage Phase 2 global clinical study, CRO’s and Vendors to ensure that the study(ies) are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines
 

EXPERIENCE AND QUALIFICATIONS:

  • Must be hands on and used to a start-up environment
  • Knowledge of GCP and ICH guidelines required
  • Proficiency in the implementation, monitoring, and management of clinical trials
  • Able to work collegially within a team and carry out duties/responsibilities with general instructions
  • Proficiency with MS Word, Excel, Outlook, PowerPoint and Microsoft Project
  • Must be willing to travel occasionally (this is an in-house position so very little travel is required)
  • Previous experience as a CPM managing more than one trial in Phase 3 or Phase 2B trial
  • Study start-up experience is highly desirable
  • Global trial experience is highly desirable
  • Demonstrated stellar track record in the oversight of all trial operational aspects including: budgets, timelines, resources, vendor selection and oversight of clinical team staff during study start-up, interim monitoring and closeout activities.
  • At least 6 years of relevant clinical experience in the pharmaceutical industry or equivalent with 3+ years as a CRA in biotech or Pharmaceutical clinical operations (not a device or diagnostics company) environment, and 1 year prior experience as a CPM preferred
  • 1+ years managing staff/direct reports preferred
  • Bachelor’s degree in a relevant scientific discipline or equivalent

To apply for a position send your resume to Jobs@JGBBioPharma.com

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200) Senior Director, Healthcare Compliance – Full Time Position (San Francisco Bay Area) BR114F

DESCRIPTION:

Candidate will partner with the leaders of the Commercial, Medical Affairs and Clinical teams, while ensuring that these business units are in compliance with company compliance policies and SOPs.  This role will lead the implementation of corporate compliance programs in multiple departments, and will oversee the design and maintenance of such programs, including but not limited to, maintaining, reviewing and updating Policies and Procedures, developing and conducting training and working in conjunction with the Compliance Operations function to ensure compliance within the company and across business units.  The successful candidate will have exceptional verbal and written communication skills, and be a collaborative, team-player with a demonstrated ability to influence people at all levels of the company to take action.  The candidate will be a strong leader and manager, with experience managing a growing team of professionals at different levels

Job Responsibilities:
  • Support the Chief Compliance Officer in building and operationalizing a robust and effective Corporate Compliance Program for a fast-paced, rapidly growing, company emerging into the Commercial market.
  • Assist the Chief Compliance Officer in the development and implementation of, compliance policy and SOPs, audit/monitoring programs and/or other risk detection and evaluation techniques to monitor compliance.
  • Provide leadership in compliance and further ownership/accountability for compliance & ethics throughout the identified departments within the organization. Effectively and efficiently identify compliance risks, prioritize focus, and implement appropriate Compliance & Ethics controls and management systems as seen with company activities such as sales and marketing, medical affairs, clinical trials, advisory boards, grants, sponsorships and charitable contributions, market access, and other activities.
  • Work cross-functionally with Legal, HR and other stakeholders on planning and implementing company and department specific compliance education programs and content customization. Will require both development and implementation of training programs and management of various 3rd party vendors for training
  • Effectively collaborate with Corporate Compliance teams of third-party business partners and business alliances, while supporting company business in meeting its goals in a compliant fashion
  • Coordinate with Legal, and other stakeholders to conduct reviews of business activities against company’s corporate compliance policies and procedures, and participate in and provide guidance for investigations and internal audits, as deemed necessary.
  • Champion proper resources are integrated with the business to help identify and implement opportunities for improvement in the effectiveness and efficiency of compliance and ethics programs. Implement appropriate metrics to drive desired compliance and ethics focus, behavior and results.

EXPERIENCE AND QUALIFICATIONS:

  • Experience in designing, building and implementing a successful corporate compliance program in a pharmaceutical/biotech company
  • Proven record of accomplishment in the areas of drafting and implementing compliance policies, training, auditing, monitoring and investigations
  • Knowledge of and experience with laws, regulations and industry guidance that affect the pharmaceutical industry including OIG and PhRMA guidelines, healthcare standard operating procedures, federal sunshine act, Foreign Corrupt Practices Act, the UK bribery act, and other anti-bribery laws federal state marketing disclosure laws, and state price reporting statutes,
  • Excellent oral and written communication skills, including presentation capabilities, and the ability to effectively influence employees across departments and throughout the company, including at Senior Management level
  • Exceptional interpersonal skills, and a collaborative team-player, with ability to resolve conflicts at all levels of the organization
  • Experience working with third-party business collaboration partners and in business alliances helpful
  • Ability to recruit and manage a high performing compliance team consisting of professionals at various levels and with various duties
  • Ability to work in a fast-paced, rapidly expanding environment, and to handle multiple complex and confidential tasks, in an organized and efficient fashion to ensure meeting very aggressive project deadlines are met in a timely manner
  • 10-15 years pharmaceutical/biotech company experience,  with 8-10 years of legal, regulatory and/or corporate compliance related experience required
  • Certified Compliance and Ethics Professional (CCEP) certification helpful, but not required
  • Bachelors degree required and Law degree (Juris Doctor) or post-graduate Healthcare related degree strongly preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

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201) Clinical Trial Manager / Sr Clinical Trial Manager – Full Time Position (San Francisco Bay Area) RF117Q

DESCRIPTION:

  • Responsible for oversight, coordination, and execution of clinical trials in support of clinical programs
  • Independently oversees and tracks study status and timelines, and feeds data into performance metrics reporting for assigned clinical projects.
  • Initiates and participates in development of clinical study documents including ICF, monitoring plans, recruitment plans, and other program/study related documents.
  • Oversees and works directly with CROs, vendors, investigators, monitors and other external partners.
  • Leads and participates in internal cross-functional clinical team meetings; serves as main point of contact study-level status updates.
  • Leads and coordinates study start-up activities including feasibility, investigational product and materials preparation, trial master file set-up, CRFs, regulatory documents, and site contracts in conjunction with relevant departments.
  • Supports and coordinates tasks related to data management, participates in database creation and user acceptance testing, input for edit checks and monitoring guidelines, data cleaning activities between study sites, data management and field monitors.
  • Supports CPM in coordination of receipt of all ancillary data e.g. safety lab data, analytic lab data, IVRS randomization data to ensure data is received at the time of database lock.
  • Conducts Trial Master File review and line listing data review

EXPERIENCE AND QUALIFICATIONS:

  • Experience: 7-10+ years clinical research experience in a pharmaceutical/biotech, CRO setting, monitoring experience
  • Phase 3 experience strongly preferred
  • Immunology or Oncology clinical trial experience preferred
  • Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
  • Strong interpersonal, organizational, and multi-tasking skills
  • Able to work independently
  • Excellent attention to detail and problem solving skills
  • Ability to work effectively work in a team setting
  • Travel domestic – up to 25%
  • Science background BS or healthcare degree required, Masters preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

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202) Scientist (QC) – Contract (Southern California) 2815V73

DESCRIPTION:

  • Carry out standard operating procedures involving basic laboratory techniques, calculations, materials measurement, operation of laboratory equipment and record keeping necessary to manufacture products. 
  • Responsible for Batch Data Records, notebooks, customer reports and work order documents. 
  • Utilize specialized technical knowledge and skills to make detailed observations and analyze data to ensure processes and products are within operating parameters. 
  • Advise manager of factors that may affect quality of product. 
  • Suggest options / ideas for corrective and preventative actions. 
  • Complete quality analysis of reagents, components and finished products in accordance with the Manufacturing Schedule. 
  • Maintain equipment, product inventories and related records as assigned. 
  • Note variances on manufacturing documents; audit and evaluate process documents and propose revisions. 
  • Complete, distribute and file records as required in accordance with Document Control Practices. 
  • Actively participate in the identification and implementation of manufacturing procedures intended to optimize existing processes and ensure achievement of regulatory requirements. 
  • Procedures will typically target improvements in assay variability, reduced cycle time, reduced manufacturing time and cost. 
  • Actively participate in troubleshooting and variable identification for specific processes or activities as assigned. 
  • Report findings to team management and members with recommendations for improvement. 
  • May research new methods or steps in a process and present findings and recommendations to the team, including developing new and revised Standard Operating Procedures. 
  • Complete, distribute and file records; prepare ad hoc reports as requested. 
  • May perform other related duties as required and/or assigned. 

EXPERIENCE AND QUALIFICATIONS:

  • Demonstrated proficiency in the use of scientific laboratory techniques, equipment and materials required. 
  • Experience in the use of basic laboratory techniques, including buffer preparation, PCR, RT-PCR, quantitative PCR, protein and nucleic acid gel electrophoresis, cloning, nucleic acid isolation/purification, restriction enzyme digests, transformations, flourometry, UV Spec. and Western, Northern and Southern blotting is beneficial. 
  • Experience with analytical methods also a plus: MALDI, CE, HPLC etc. 
  • Experience with radioactive isotopes handling is also desired. 
  • Demonstrated ability to carry out scientific procedures and make recommendations for improvement required. 
  • Experience assessing current processes and techniques and implementing procedural improvements preferred. 
  • Good problem solving skills necessary. 
  • Working knowledge of manufacturing related computer software preferred. Intermediate math skills required.
  • Requires at least two (2) years experience in the application of Molecular Biology laboratory techniques in a manufacturing environment or research laboratory. 
  • Bachelor's Degree in Molecular biology, biochemistry or related life science with at least 5 years of lab experience.
  • Master's Degree in Molecular biology, biochemistry or related life science with at least 2 years of lab experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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203) Clinical Project Manager – Full Time Position - 1-2 days/wk in-house (San Francisco Bay Area) ZG104M

DESCRIPTION:

  • Prepares and revises clinical protocols and informed consent documents
  • Participates in development of case report forms
  • Manages study supplies
  • Recruits and qualifies investigational sites for participation in clinical studies
  • Ensures studies are conducted in compliance with regulatory requirements
  • Oversees monitoring and close-out of study sites
  • May be able to work 20-40% from home, 1-2 days on site

EXPERIENCE AND QUALIFICATIONS:

  • Must be able to work independently while contributing to a team; take initiative
  • Demonstrate excellent verbal and written communication skills
  • Familiarity with medical and pharmaceutical industry terminology and practices
  • Proven effectiveness as a team leader
  • Prior experience successfully managing multifaceted studies from inception through implementation and completion.
  • Computer proficiency in Microsoft Word, Excel, and PowerPoint are required. 
  • Experience with MS Project a plus
  • Ophthalmology or Oncology experience required
  • 4-year degree, preferably in a scientific or health care discipline
  • 4-5 years of prior experience in the Clinical Research Associate role, plus at least two years of CPM experience.
  • 25-40% travel domestic

To apply for a position send your resume to Jobs@JGBBioPharma.com

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204) Scientist II (Purification) – Contract (Southern California) 73T2809

DESCRIPTION:

  • Carry out standard operating procedures involving basic laboratory techniques, calculations, materials measurement, operation of laboratory equipment and record keeping necessary to manufacture products. 
  • Responsible for Batch Data Records, notebooks, customer reports and work order documents. 
  • Utilize specialized technical knowledge and skills to make detailed observations and analyze data to ensure processes and products are within operating parameters. 
  • Advise manager of factors that may affect quality of product. 
  • Suggest options / ideas for corrective and preventative actions. 
  • Complete quality analysis of reagents, components and finished products in accordance with the Manufacturing Schedule. 
  • Maintain equipment, product inventories and related records as assigned. 
  • Note variances on manufacturing documents; audit and evaluate process documents and propose revisions. 
  • Complete, distribute and file records as required in accordance with Document Control Practices. Actively participate in the identification and implementation of manufacturing procedures intended to optimize existing processes and ensure achievement of regulatory requirements. 
  • Procedures will typically target improvements in assay variability, reduced cycle time, reduced manufacturing time and cost. 
  • Actively participate in troubleshooting and variable identification for specific processes or activities as assigned. 
  • Report findings to team management and members with recommendations for improvement. 
  • May research new methods or steps in a process and present findings and recommendations to the team, including developing new and revised Standard Operating Procedures. 
  • Complete, distribute and file records; prepare ad hoc reports as requested. 
  • May perform other related duties as required and/or assigned. 

EXPERIENCE AND QUALIFICATIONS:

  • Requires at least two (2) years experience in the application of Molecular Biology laboratory techniques in a manufacturing environment or research laboratory. 
  • Demonstrated proficiency in the use of scientific laboratory techniques, equipment and materials required. 
  • Experience in the use of basic laboratory techniques, including buffer preparation, Protein Purification using column chromatography (AKTA system experience preferred,) TFF, gel electrophoresis and various cell lysis methods.  
  • Experience assessing current processes and techniques and implementing procedural improvements preferred. 
  • Good problem solving skills necessary. 
  • Working knowledge of manufacturing related computer software preferred. 
  • Advanced math skills required.
  • Bachelor's Degree in Molecular biology, biochemistry or related life science with at least 5 years of lab experience.
  • Masters's Degree in Molecular biology, biochemistry or related life science with at least 2 years of lab experience.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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205) Senior Statistical Programmer – Full Time Position (San Francisco Bay Area) ZA111H

DESCRIPTION:

  • Participate in CRF design, database review, data management plan, data review, data validation procedures, and review of data listings.
  • Design, develop, implement, and maintain software for the monitoring of ongoing studies, reporting, and analysis of clinical trials. 
  • Provide consistency across protocols within a project on CRFs, database design, analysis files, and tables, listings, and graphs.
  • Produce data listings, summary tables and graphics for interim and final analyses and publications.
  • Create statistical files for statistical analysis. 
  • Integrate data across studies within a project. 
  • Test, document, review and validate all programs according to department guidelines.
  • Provide consulting and systems support for applications software. 
  • Develop new applications software and identify key feature set.
  • Coordinate data transfer and/or programming standards with CROs and vendors. 
  • Work with minimal supervision.

EXPERIENCE AND QUALIFICATIONS:

  • Expertise in SAS programming language (especially data step, and summarization procedures), report generation, and standards for programming and validation.
  • Experienced in macro writing. 
  • Knowledge of advanced statistical procedures in SAS including LIFETEST, MIXED, GLM, especially SAS/GRAPH (required). 
  • Experience with CDISC data standards required.
  • Knowledge of database and data warehouse theory. 
  • Data mining experience is a plus.
  • Understanding of regulatory guidelines that affect statistical deliverable.
  • Ability to work on multiple tasks simultaneously and meet project deadlines.
  • Good verbal and written communication skills.
  • MA/MS in a related field with 5 years experience, or BA/BS in computer science, statistics, math with 7 years experience. 
  • Minimum of 7 years of SAS programming and 5 years of clinical trial experience.
  • Mandarin language skills is a plus but not required

To apply for a position send your resume to Jobs@JGBBioPharma.com

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206) Recruiting Assistant – Part Time Position (San Francisco Bay Area Preferred)

DESCRIPTION:

This is an entry level work from home position with flexible hours that may range from 15 to 30+ hours per week, depending on workload.   This work can be completed during any shift (day, evening, night), but occasionally specific hours may be required.   In this role you will be responsible for searching information from job databases such as LinkedIn and then entering that information along with the LinkedIn PDF or attached resume into an Applicant Tracking System.  This position helps the technical recruiting process and you will work with multiple recruiters who are searching for particular skills for open positions.  You will use a search criteria provided by each recruiter for a particular job.  You will search for candidates who match the criteria for the job specifications. 

Essential Job Functions:
  • Receive search instructions from various recruiters
  • Perform timely and accurate searches in LinkedIn or other databases according to instructions provided
  • Deciding on profile ‘fit’ according to criteria provided
  • Entering those profiles who fit the criteria into a database, completing various fields within the database according to procedure
  • Attach the LinkedIn PDF or resume into the database
  • Emailing list of profiles entered to the recruiter(s)

EXPERIENCE AND QUALIFICATIONS:

  • Excellent knowledge of internet and LinkedIn Professional Networking database
  • Must be able to understand the various search fields on LinkedIn (by skill, company, location, connection, etc.)
  • Fast and accurate typing/data entry skills
  • Attention to detail, including accurate spelling
  • Thoroughness, decision making, independence, and analyzing information
  • Positive attitude and eagerness, and adaptability
  • Proficiency with MS Office products, email and general computer skills. 
  • MS Excel proficiency a plus
  • Must have your own home computer with high speed internet service
  • Excellent written and verbal communication skills, including a high command of the English language
  • Bachelor’s degree preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

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207) Lead CRA (in-house) – Full Time Position (San Francisco Bay Area) ZW104M

DESCRIPTION:

  • Responsible for tasks that relate to the operations and management of clinical trials. 
  • Monitoring clinical studies of investigational and approved products. This may include qualification, initiation, interim monitoring, and close out site visits.
  • Acting as primary liaison between the study site staff and sponsor company.
  • Monitoring studies by reviewing and reporting to the sponsor on the following: site enrollment and subject status, findings at monitoring visits, protocol deviations/exceptions, serious adverse events and laboratory abnormalities. 
  • Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues.
  • Reviewing investigational product accountability, including discrepancy resolution.
  • Processing or overseeing transmission of study data to sponsor according to protocol-specified timelines.
  • Reviewing data queries and listings, and working with the study site staff to resolve data discrepancies.
  • Overseeing the study site staff to assess protocol compliance and appropriate data collection including proper handling, storage and shipment of biological samples.
  • Maintaining consistent contact with the study site staff, including investigators, coordinators, client personnel, and other individuals involved in the clinical study.
  • Visit report writing and site correspondence.
  • Training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion.
  • Managing the preparation, collection and maintenance of trial regulatory documents. 
  • Maintaining complete and accurate study files, and reviewing files to ensure all appropriate documentation is present.
  • Managing, preparing, sending, tracking, and returning investigational supplies at individual sites. 
  • Managing investigational product ordering, packaging, labeling and ongoing inventory.
  • Managing the reporting of serious adverse events. 
  • Developing study-related documents such as: protocols, case report forms, informed consent forms, study binders, standard operating procedures, study guidelines, study management/tracking tools, and monitoring plans.
  • Preparing contracts with investigators/hospitals, and negotiating budgets and payment schedules. 
  • Planning, preparing for, and giving presentations at investigator meetings. 
  • Development and management of study timelines.
  • Assisting with medical writing and regulatory submissions, such as interim, final study, and annual progress reports. Developing or updating Investigational Product Brochures. Preparing documentation for regulatory submissions (IND, NDA, BLA, IDE, PMA).
  • Visit report writing and site correspondence.
  • Interacting with project manager (sponsor or other) through formal and informal communications, including providing updates, identifying issues, sharing of information and instructions.
  • Managing the resource requirements of the project.
  • Supervision and guidance of CRAs, CR Assistants, and external CROs. Conduct of co-monitoring, training and audit visits. Creation of visit report templates. Review of completed visit reports.
  • Managing all aspects of the implementation of a clinical study. 
  • Interdepartmental liaison working with regulatory, data management, bSelection and management of outside vendors, such as CROs, DM groups, investigational product packaging, and central laboratories.

EXPERIENCE AND QUALIFICATIONS:


  • Detail oriented. 
  • Excellent organizational skills, strong interpersonal and communications skills, and strong problem solving skills.
  • Familiarity with medical and pharmaceutical industry, and related terminology and practices. 
  • Extensive knowledge of FDA regulations and their practical implementation.
  • Willingness to travel.
  • Computer proficiency in Microsoft Word, Excel, and PowerPoint
  • Oncology, vaccines or dermatology experience a plus
  • RN or BS degree in biological sciences or related field or equivalent combination of education and experience: 4 or more years successful CRA experience

To apply for a position send your resume to Jobs@JGBBioPharma.com

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208) Senior Manager, Bioinformatics – Full Time Position (Midwest) B73FN

DESCRIPTION:

The purpose of this position is to lead a bioinformatics team that focuses on two areas:  (1) develop and maintain the informatics pipelines and algorithms that comprise our knowledge base, and (2) provide project-based bioinformatics support to the Pharma and Clinical Diagnostic Services business to enable the application of cancer knowledge base and bioinformatics methods.
This team mission is to develop and continuously improve methods for identifying the driver aberrations in cancer through the systematic analysis of high-throughput molecular profiling data.

RESPONSIBILITIES

  • Manage a bioinformatics team that provides: Algorithm and method development in support of the continuous growth and improvement of core compendium of genomic data and cancer knowledge. and Project based bioinformatics support to our Pharma Services and Clinical Diagnostics businesses
  • Organizing and leading the Bioinformatics team to ensure a robust and scalable end to end working bioinformatics pipeline and, working with customers and other teams, provide custom bioinformatics analysis and solutions.
  • Provide strategic direction and guidance to Bioinformaticians in their daily analysis and product development efforts as well as their individual career development and growth.
  • Critical assessment of experimental data to identify patterns that improve content usability to answer core questions
  • Guide team in matrixed environment. Ability to allocate development resources to staff projects appropriately in that environment.
  • Provide accurate scoping and estimation of development efforts for projects based on product requirements and a solid grasp of the relevant bioinformatics tools.
  • Investigate, create and develop new methods and technologies for project advancement.
  • Coordination with other R&D functions as well as Product Management and Marketing to identify critical product development features to prioritize for future releases
  • Communication and coordination with leadership to promote effective systems development.
  • Maintain high level of professional expertise through familiarity with current scientific literature, competing technologies and/or products and attendance of scientific seminars and meetings.
  • Communicates the significance of recent scientific and technology developments to peer group.
  • Collaborate with sequencing teams and clinical researchers to qualify product performance.
  • When needed, select external vendors and consultants and manage engagements.
  • Enthusiasm to collaborate with other departments as a technical consultant.
  • Serve as internal technical expert

EXPERIENCE AND QUALIFICATIONS:

  • Expertise in both bioinformatics and genomics applications is required.
  • Proven understanding and experience in the fields of genomics, experimental data processing, high-throughput data analysis, and genomic databases. 
  • Understanding of basic biology and cancer biology a must.
  • Firm grasp of univariate statistical analysis fundamentals necessary. 
  • Experience with multivariate statistics or statistical modeling a plus.
  • Candidates should have knowledge of leading NGS processing techniques for the quantification of gene expression and copy number, and the identification of somatic mutations, gene fusions, and genomic rearrangements.  Direct experience processing NGS data is a plus.  Candidates should be familiar with the limitations of the various NGS platforms and informatic pipelines, so that data are appropriately integrated into analyses.
  • Strong computational skills, particularly in data parsing, cleansing, data modeling, analysis, and database design and implementation.
  • Solid knowledge of unix/linux. Experience with cluster computing a plus.
  • Previous bioinformatics and scientific programming experience necessary; experience with Spotfire, Pipeline Pilot, R, SQL, and NGS a plus.
  • Ability to review, synthesize, and present scientific data and methods.
  • Good written and verbal communication skills.
  • Inspires, motivates and collaborates with others.
  • Anticipates needs and problems while creating solutions.
  • 7 or more years of post-graduate work experience
  • PhD in computer science, computational biology, biostatistics, bioinformatics, or similar (MS acceptable for the candidate with the right experience)

To apply for a position send your resume to Jobs@JGBBioPharma.com

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209) Sr. Staff Scientist, Translational Medicine – Full Time (Midwest) M73QL

DESCRIPTION:

  • Provide leadership in the application of cancer data sciences to translational medicine and diagnostics opportunities. 
  • Will be expected to exhibit scientific leadership of cancer genome data sciences.
  • Provide scientific review, and ensure that results intended for internal and external customers are presented clearly and effectively.
  • Strong scientific and technical leadership is expected, along with ability to foster collaboration and innovation from the Translational Medicine team.
  • Partner with bioinformatics colleagues to develop and assess bioinformatics strategies.
  • Contribute to the development of innovative methods, software platforms, and infrastructure.
  • Support and/or lead the development of scientific presentations for scientific conferences and publications.
  • May be required to perform other related duties as required and/or assigned. 

EXPERIENCE AND QUALIFICATIONS:

  • Requires a minimum of  5 years of relevant post-graduate experience in a cancer focused translational medicine related field. Industry experience is a plus.
  • Requires demonstrated expertise and experience working with cancer genomics data, along with a solid understanding of tumor biology and oncogenic signaling pathways.
  • Proven scientific excellence exemplified by lead author publications in high impact trade journals and/or significant contributions to industry programs.
  • Ability to work independently and collaboratively.
  • Requires ability to communicate effectively in spoken and written English language.
  • Prior work experience in industry or tenure-track academic position preferred.
  • Solid understanding of common statistical approaches used with genomic data preferred. 
  • PhD and/or MD in relevant field required.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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210) Staff Scientist, Bioinformatics – Full Time (Midwest) W73BH

DESCRIPTION:

  • Seeking individuals with expertise in bioinformatics and an understanding of the cancer genome to identify cancer driver aberrations and to associate those genetic events with potential therapeutic strategies.  
  • Work collaboratively in a matrix environment to develop data analysis strategies to address key questions about cancer for our internal and external customers.  
  • Applications include diagnostics, target and biomarker discovery, indication selection, and clinical development strategies.
  • Collaborate with Medical Sciences Informatics (MSI) colleagues to understand our customer’s questions about cancer, patients, and drugs, and develop data analysis strategies and plans to answer them.
  • Implement bioinformatics data integration and analysis pipelines in Pipeline Pilot and/or scripting languages, drawing on MSI's large collection of high-throughput genomic data and sample annotations.
  • Develop visualization environments in Spotfire to enable scientists to explore the data and answer questions.
  • Written and verbal presentation of results and methods.
  • May be required to perform other related duties as required and/or assigned.

EXPERIENCE AND QUALIFICATIONS:

  • Proven understanding and experience in the fields of genomics, experimental data processing, high-throughput data analysis, and genomic databases. Understanding of basic biology and cancer biology a must.
  • Firm grasp of univariate statistical analysis fundamentals necessary. Experience with multivariate statistics or statistical modeling a plus.
  • Candidates should have knowledge of leading NGS processing techniques for the quantification of gene expression and copy number, and the identification of somatic mutations, gene fusions, and genomic rearrangements.  Direct experience processing NGS data is a plus.  Candidates should be familiar with the limitations of the various NGS platforms and informatic pipelines, so that data are appropriately integrated into analyses.
  • Strong computational skills, particularly in data parsing, cleansing, data modeling, analysis, and database design and implementation.
  • Solid knowledge of unix/linux. Experience with cluster computing a plus.
  • Previous bioinformatics and scientific programming experience necessary; experience with Spotfire, Pipeline Pilot, R, SQL, and NGS a plus.
  • Ability to review, synthesize, and present scientific data and methods.
  • Good written and verbal communication skills.
  • Inspires, motivates and collaborates with others.
  • Anticipates needs and problems while creating solutions.
  • 5 years of post-graduate work experience
  • PhD in computer science, computational biology, biostatistics, bioinformatics, or similar (MS acceptable for the candidate with the right experience)

To apply for a position send your resume to Jobs@JGBBioPharma.com

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211) Scientist III, Bioinformatics – Full Time Position (Midwest) P73NA

DESCRIPTION:

  • Collaborate with scientists to understand customer’s questions about cancer, patients, and drugs, and to develop data analysis strategies and plans to answer them.
  • Collaborate with colleagues to understand our customer’s questions about cancer, patients, and drugs, and develop data analysis strategies and plans to answer them. 
  • Implement bioinformatics data integration and analysis pipelines in Pipeline Pilot and/or scripting languages, drawing on large collection of high-throughput genomic data and sample annotations. 
  • Develop visualization environments in Spotfire to enable scientists to explore the data and answer questions. 
  • Written and verbal presentation of results and methods. 
  • May be required to perform other related duties as required and/or assigned. 

EXPERIENCE AND QUALIFICATIONS:

  • Proven understanding and experience in the fields of genomics, experimental data processing, high-throughput data analysis, and genomic databases. 
  • Understanding of basic biology and cancer biology a must.
  • Firm grasp of univariate statistical analysis fundamentals necessary.  
  • Experience with multivariate statistics or statistical modeling a plus.
  • Strong computational skills, particularly in data parsing, cleansing, data modeling, analysis, and database design and implementation. 
  • Solid knowledge of unix/linux.  
  • Experience with cluster computing a plus. 
  • Ability to review, synthesize, and present scientific data and methods. 
  • Outstanding written and verbal communication skills. 
  • Previous bioinformatics and scientific programming experience necessary; experience with Spotfire, Pipeline Pilot, R, SQL, and NGS a plus. 
  • Scientific experience in cancer study and/or research a plus. 
  • Pharmaceutical experience and lead author publications are highly valued. 
  • Inspires, motivates and collaborates with others. 
  • Anticipates needs and problems while creating solutions.
  • Requires a Masters and/or PhD along with minimum 5 years post-graduate work experience in related field

To apply for a position send your resume to Jobs@JGBBioPharma.com

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212) Senior Data Manager – Full Time Position (San Francisco Bay Area) GL85B

DESCRIPTION:

  • Responsible for leading all activities of data management for clinical trials from start up to close out. 
  • Work with internal development colleagues and external clients to ensure delivery to time, quality and cost expectations.
  • Ensure that management’s clinical development objectives are met with regards to Data Management activities
  • Provide operational leadership to the direction, planning, execution, collection and interpretation of all clinical data to the highest quality standards
  • Report status of clinical data management activities to project teams and management
  • Involved in data preparation for reporting clinical study results for regulatory filings, publications, presentations
  • Conduct clinical data management activities using OmniComm’s Trial Master® and Oracle’s Clintrial® Data Management Systems
  • Develop and implement data management standard operating procedures
  • Create written data management plans
  • Design database structures and case report forms consistent with CDISC and CDASH initiatives
  • Manage group of junior data management personnel
  • Work with third-party vendors to develop data transfer specifications
  • Responsible for directing, managing and training CRO/internal staff as appropriate
  • Oversees the data management work and performs day-to-day data management activities. These include resources planning, developing and implementing standard data management procedures, training and supervising junior data management personnel, performing day-to-day data management activities according to ICH guidelines, regulatory requirements and the company’s standard operating procedures. 

EXPERIENCE AND QUALIFICATIONS:


  • Advanced proficiency in core data management activities (e.g., case report form design, data edit specifications and data validation, creation of data management plans, expert use of adverse events and concomitant medication coding dictionaries, attention to detail and data quality)
  • Excellent communication skills and ability to direct others work efforts
  • Strong track record of leading clinical data management activities 
  • Undergraduate or higher degree; at least five years of experience in clinical trial data management in a pharmaceutical, biotech or CRO setting 
  • Bachelors with 5-8 years experience in pharmaceutical / biotech industry

To apply for a position send your resume to Jobs@JGBBioPharma.com

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213) Technical Writer – Contract (San Francisco Bay Area) 73N4199

DESCRIPTION:

  • Develops scientific/technical/marketing content for delivery in a variety of formats
  • Researches, drafts or revises content, routes content for input, and finalizes content for delivery to customers
  • Simultaneously handles multiple deliverables
  • Works under supervision of a lead writer or manager
  • Develops content that meet internal and external customer requirements
  • Meets agreed upon timelines
  • Follows relevant processes and procedures
  • Follows internal style guide for consistency
  • Follows corporate brand and voice guidelines 

EXPERIENCE AND QUALIFICATIONS:

  • Excellent written communications skills.
  • Ability to apply technical writing principles to all work
  • Ability to develop content that is accurate, clear, concise, and meets the needs of the target audience
  • Understands technical/marketing/scientific content and can effectively adapt structure, tone, and style to meet objectives.
  • Ability to work on short and long-term projects simultaneously and meet timelines.
  • Knowledge of relevant style guide(s) and best practices.
  • Proficiency in authoring, workflow, and file management tools.
  • Attention to detail, knowledgeable of biotech industry and competitors
  • Bachelor’s degree in the biological sciences or related field; advanced degree preferred.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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214) Sr. Product Manager, Software Solutions – Full Time Position (San Francisco Bay Area) B73XS

DESCRIPTION:

Position Objective 

The objective of this position is to develop and manage portfolio of software products and services that provide value added growth for the business segment. This person will develop business cases and own all product management responsibilities for a growing portfolio of software products and services. Will develop and manage a portfolio of on-market and new software products and services. Will be responsible for development of product definition, positioning, pricing and product lifecycle management. Responsibilities include developing market research, leading product management function in new product development teams, managing inventory, pricing, customer communications, support, and revenue forecasts. This position will manage transitioning of products from standalone desktop software to browser based products along with licensing and commercialization models (SaaS) and will manage maintenance and support plans. This position reports to the Director of IT Solutions Product Management.

  • Manage worldwide supply, demand, revenue, margin and pricing for product portfolio; update and present forecasts regularly to management, finance, and manufacturing teams. 
  • Analyze market trends, customer requirements and competitive strategy, and identify opportunities for increasing customer and business value through product differentiation. 
  • Lead new product development process from concept through commercialization, including voice of customer research, definition of customer and product requirements and value proposition, formulating and communicating global launch plans including commercialization strategy, public presentations, competitive analysis, forecasting, positioning and training of internal groups, service, support and sales. 
  • Lead business aspects of both internally-developed products, as well as those leveraged from external collaborations. .
  • Strong leader within cross-functional teams developing the right product to fill market needs, and will serve as the customer advocate interacting w/ functional partners including R&D, Program Management, Manufacturing, Market Development, Finance, Customer Services, Quality and Regulatory Associates. 
  • Will partner closely with the Instrument/Product Managers and Technical Marketing Specialists to ensure system synergies and optimal customer experiences. 
  • The software strategy will be developed and executed in concert with the centrally managed CIO office- ensuring best practices from one division are shared across all operating groups.
  • Desired applicants should bring specific experiences in building software development communities, designing software and building scalable architectures as well as SDKs. 
  • Some knowledge of biological sciences and/or genomics is desirable, but not required. An aptitude and interest in learning science including bioinformatics is important. 
  • Candidate must possess a track record of success in driving business innovation, product development, building/leading cross functional teams and effective executive level communication.
  • Implement business strategy for software, including software as a product or a service 
  • Lead product definition teams, defining critical product requirement documents with prioritized features and corresponding business or financial justification with ROI.
  • Assess and evaluate competitive landscape – including product offerings.
  • Monetize software through direct and indirect economic business models, segregating differentiated value propositions for customer segments
  • Accurate market analysis, value proposition and forecasting for new products 
  • Write business cases communicating global launch plans that include regulatory strategy, reimbursement approach, competitive analysis, forecasting, pricing, positioning and training of internal groups
  • Set pricing to meet revenue and profitability goals
  • Develop customer oriented sales tools and collateral in partnership with market development
  • Manage total product lifecycle, setting organizational cadence for retirement, refresh or enhancement of existing products- in concert with software engineering organization
  • Contribute globally to the company CIO office as part of larger stakeholder community
  • Develop a thorough knowledge of target customer segments, markets and the competition
  • Contribute to overarching IT solutions strategy and roadmap
  • May be required to perform other related duties as required and/or assigned

EXPERIENCE AND QUALIFICATIONS:

  • Outstanding written and verbal communication skills are required
  • Track record of success in launching software products and services
  • Demonstrated ability to develop business cases, customer and product requirements for strategic and/or complex products, soliciting and integrating Voice of Customer and User Centered Innovation inputs
  • Demonstrated experience successfully managing product lines, pricing, and forecasting
  • Strong leadership skills within cross functional teams; a demonstrated leader through influence with strong negotiation skills
  • Is customer-centric and keenly aware of markets, trends and competitors
  • Is authentic, transparent and leads by example, holding self and others accountable 
  • Organized with strong project management skills
  • Demonstrates a sense of urgency, contagious optimism and a “can do” attitude
  • Inspires, motivates and collaborates with others; team-first attitude
  • Stretches across borders, breaks silos and builds effective partnerships with customers and colleagues
  • Adept with software development life cycle methodologies and software technologies
  • Experience with validated and regulated markets is a plus
  • 25% travel (domestic and international) is required on periodic basis. 
  • This position is not eligible for relocation benefits.
  • Works in an office environment. 
  • 5-8 years’ experience in software Product Management required
  • Bachelor's degree in software development or information management (MBA strong plus)

To apply for a position send your resume to Jobs@JGBBioPharma.com

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215) Sr. Product Manager, Software – Full Time Position (San Francisco Bay Area) B73XS

DESCRIPTION:

The objective of this position is to develop and manage portfolio of software products and services that provide value added growth for the business segment. This person will develop business cases and own all product management responsibilities for a growing portfolio of software products and services. Will develop and manage a portfolio of on-market and new software products and services. Will be responsible for development of product definition, positioning, pricing and product lifecycle management. Responsibilities include developing market research, leading product management function in new product development teams, managing inventory, pricing, customer communications, support, and revenue forecasts. This position will manage transitioning of products from standalone desktop software to browser based products along with licensing and commercialization models (SaaS) and will manage maintenance and support plans. This position reports to the Director of IT Solutions Product Management.

  • Manage worldwide supply, demand, revenue, margin and pricing for product portfolio; update and present forecasts regularly to management, finance, and manufacturing teams.
  • Analyze market trends, customer requirements and competitive strategy, and identify opportunities for increasing customer and business value through product differentiation.
  • Lead new product development process from concept through commercialization, including voice of customer research, definition of customer and product requirements and value proposition, formulating and communicating global launch plans including commercialization strategy, public presentations, competitive analysis, forecasting, positioning and training of internal groups, service, support and sales.
  • Lead business aspects of both internally-developed products, as well as those leveraged from external collaborations.
  • Strong leader within cross-functional teams developing the right product to fill market needs, and will serve as the customer advocate interacting w/ functional partners including R&D, Program Management, Manufacturing, Market Development, Finance, Customer Services, Quality and Regulatory Associates.
  • Will partner closely with the Instrument/Product Managers and Technical Marketing Specialists to ensure system synergies and optimal customer experiences.
  • The software strategy will be developed and executed in concert with the centrally managed CIO office- ensuring best practices from one division are shared across all operating groups.
  • Desired applicants should bring specific experiences in building software development communities, designing software and building scalable architectures as well as SDKs.
  • Some knowledge of biological sciences and/or genomics is desirable, but not required. An aptitude and interest in learning science including bioinformatics is important.
  • Candidate must possess a track record of success in driving business innovation, product development, building/leading cross functional teams and effective executive level communication.
  • Implement business strategy for software, including software as a product or a service
  • Lead product definition teams, defining critical product requirement documents with prioritized features and corresponding business or financial justification with ROI.
  • Assess and evaluate competitive landscape – including product offerings.
  • Monetize software through direct and indirect economic business models, segregating differentiated value propositions for customer segments
  • Accurate market analysis, value proposition and forecasting for new products
  • Write business cases communicating global launch plans that include regulatory strategy, reimbursement approach, competitive analysis, forecasting, pricing, positioning and training of internal groups
  • Set pricing to meet revenue and profitability goals
  • Develop customer oriented sales tools and collateral in partnership with market development
  • Manage total product lifecycle, setting organizational cadence for retirement, refresh or enhancement of existing products- in concert with software engineering organization
  • Contribute globally to the company CIO office as part of larger stakeholder community
  • Develop a thorough knowledge of target customer segments, markets and the competition
  • Contribute to overarching IT solutions strategy and roadmap
  • May be required to perform other related duties as required and/or assigned

EXPERIENCE AND QUALIFICATIONS:

  • Outstanding written and verbal communication skills are required
  • Track record of success in launching software products and services
  • Demonstrated ability to develop business cases, customer and product requirements for strategic and/or complex products, soliciting and integrating Voice of Customer and User Centered Innovation inputs
  • Demonstrated experience successfully managing product lines, pricing, and forecasting
  • Experienced with software Product Management from concept through commercialization and all phases in between
  • Experience with Cloud/SaaS based software
  • Experienced with software pricing and/or training in pricing such as from Pragmatic Marketing Certification or other similar
  • Strong leadership skills within cross functional teams; a demonstrated leader through influence with strong negotiation skills
  • Is customer-centric and keenly aware of markets, trends and competitors
  • Is authentic, transparent and leads by example, holding self and others accountable
  • Organized with strong project management skills
  • Demonstrates a sense of urgency, contagious optimism and a “can do” attitude
  • Inspires, motivates and collaborates with others; team-first attitude
  • Stretches across borders, breaks silos and builds effective partnerships with customers and colleagues
  • Adept with software development life cycle methodologies and software technologies
  • Experience with validated and regulated markets is a plus
  • 25% travel (domestic and international) is required on periodic basis.
  • This position is not eligible for relocation benefits.
  • Works in an office environment.
  • 5-8 years’ experience in software Product Management required
  • Bachelor's degree in software development or information management (MBA strong plus)

To apply for a position send your resume to Jobs@JGBBioPharma.com

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216) Clinical Recruiter – Contract or Full Time Position (San Francisco Bay Area) NG104B

DESCRIPTION:

  • Coordinate with Management Team and Staffing Manager to determine needs 
  • Source and recruit clinical research professionals (Clinical Research Associates, Clinical Project Managers, Clinical Research Assistants and Clinical Line Managers) within the pharmaceutical, biotech, and medical device industry for contract and permanent positions.
  • Identify potential candidates via: internet recruiting, job postings, referrals, pro-active recruiting methods, i.e. cold calling, networking, staff agencies, LinkedIn, maintain database of candidates and professional recruiters
  • Review and respond to incoming and posted resumes
  • Present and sell open jobs to candidates based upon the needs of the position and the candidate's qualifications and preferences
  • Conduct initial phone screens and/or face to face interviews of potential candidates
  • Present qualified candidates to internal managers; coordinate interviews between managers and candidates, and clients, where applicable
  • Conduct/coordinate background screens, skill evaluations, and professional reference checks for all potential new hires
  • Arrange travel for incoming candidates, and submit expense reports for candidate travel
  • Aggressively follow-up with candidates and recruiters (if applicable) throughout the recruitment process from initial interview to final offer and closing
  • Closing responsibilities for all candidates who are extended an offer including securing agreement with the candidate on an entire compensation and benefits package and securing their firm acceptance of the offer.
  • Attend association and industry meetings, job fairs for networking and recruiting
  • Update internal candidate database on regular basis with interview information, client and candidate contacts, new job openings, and placements 
  • Maintain database by calling/e-mailing network minimally every 1-2 months in order to keep contacts active

EXPERIENCE AND QUALIFICATIONS:


  • Bachelors Degree from an accredited university or college required 2+ years experience as a recruiter in either a permanent or contract capacity
  • Knowledge of and experience in a staffing environment, preferably within a recruitment agency, with an understanding of gross profit margins, markup, and overall profitability to drive recruiting strategy
  • Experience recruiting for clinical research positions and/or knowledge of the clinical industry is required 
  • Ability to self-motivate and develop personal recruiting strategies to meet individual goals
  • Well developed telephone marketing, recruiting and networking skills and the ability to spend 4+ hours per day on the telephone 
  • Exceptional interpersonal, relationship building, presentation and communication skills (verbal & written)
  • Enthusiastic, positive, and persistent approach to business
  • Detail oriented with excellent organizational and time management skills
  • Ability to excel in a fast paced, team environment 
  • Computer proficiency with Outlook, Word & Excel and familiarity with databases

To apply for a position send your resume to Jobs@JGBBioPharma.com

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217) Diagnostics Product Line Business Owner – Full Time Position (San Francisco Bay Area) RC103X

DESCRIPTION:

  • Responsible for leading, developing and executing the business, product and go to market (GTM) strategy including business model optimization, new market introduction and ongoing P/L operations for the product line. 
  • Work closely with the extended marketing, product management, sales, software development and executive teams to develop business plans based on in-depth market analysis, define the overall product strategy, and define and implement the product GTM strategy and programs.  
  • Be the key go-to business / product line leader who owns end-to-end business success for the product in the market including P/L.
  • Own the GTM strategy, planning and execution engaging with cross-functional teams to align and manage key capabilities and timelines for successful delivery.
  • Be the go-to person for understanding and guiding product strategy and together with NGS development team drive product roadmap and execution.
  • Conduct market research and develop frameworks for identifying, evaluating and prioritizing business opportunities.
  • Work with business development / channel development to recruit and support new and existing channel partners expanding market reach and penetration.
  • Work with marketing to define, execute and deliver successful marketing programs to generate demand and achieve revenue targets.
  • Be the business and product champion/evangelist externally at events, customer and channel engagements, and the passionate voice of the customer internally.

EXPERIENCE AND QUALIFICATIONS:

  • Entrepreneur with exceptional value creation instincts and problem solving skills.
  • Deep understanding of the biological diagnostics marketplace with experience successfully launching new molecular diagnostics products.
  • A passionate self-starter with a combination of business, product, and technical knowledge who has a proven ability to kick-start new products and see them through to successful completion
  • Able to evaluate, frame and make compelling recommendations so the executive team can effectively make business strategy and product investment decisions.
  • A strong leader and evangelist who is results driven, detailed, follows through, and has an ability to work effectively at all levels within the organization, customers and partners.
  • Strong analytical skills with experience in data driven decision-making.
  • Comfortable working with scientific, technical, medical and non-technical personnel with exceptional communication skills, including the ability to effectively present to customers.
  • MD or BS in life sciences with MBA or equivalent experience (including relevant advanced studies preferred, ie MS, PhD, bioinformatics certification, etc).
  • Solid business experience with a minimum five years experience in marketing, business, business development and/or channel development.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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218) Document Coordinator – Contract (New York) 2223G73

DESCRIPTION:

  • Retrieve and coordinate the workflow of manufacturing batch records, perform activities within the document management function associated with the review of manufacturing records and product disposition in the current ERP, and laboratory systems and Excel. 
  • Maintain filing of completed batch records.  
  • Assist internal customers in the retrieval of batch records. 

EXPERIENCE AND QUALIFICATIONS:

  • High attention to detail is required.  
  • Ability to work independently as well as part of a team.  
  • Ability to effectively interact with department personnel and internal customers in a way that enhances department productivity and improves processes.  
  • Ability to communicate both verbally and electronically to satisfy requirements as needed. 
  • Excellent organizational skills required.  
  • Must demonstrate exceptional computer skills with  Excel, Word, Access databases and other programs as required.  
  • Must possess self-motivation and positive attitude.
  • High School diploma required.  
  • Associates degree preferred with 2 years experience in related cGMP field, or minimum of 1 year degree in business or technical discipline with 2+ years experience in a role which demonstrates attention to detail with high standards to error free work. 

To apply for a position send your resume to Jobs@JGBBioPharma.com

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219) Regional Clinical Research Associate – Full Time Position (Texas) N104BX

DESCRIPTION:

  • Primary responsibility of this position is to provide site management and monitoring of clinical research studies. 
  • Verification of reported study data
  • Investigational product accountability
  • Oversight of compliance and training of site staff on regulatory and protocol-related issues
  • Review of regulatory documents
  • Accurate and timely documentation
  • Reporting and communication
  • Oversight of safety reporting   

EXPERIENCE AND QUALIFICATIONS:


  • Infectious disease, oncology, dermatology and/or ophthalmology experience a plus.
  • Understanding of regulatory principles and practices
  • Attention to detail
  • Ability to efficiently perform multiple tasks
  • Ability to identify and solve logistical problems
  • Excellent organizational skills
  • Ability to maintain an effective travel schedule
  • Flexibility with changing priorities
  • Effective communication and personal skills necessary for successful teamwork.
  • Travel up to 65% may be required.
  • General computer skills with proficiency in PC-based Microsoft Word and Excel are mandatory. 
  • Qualified candidates must have an RN or 4-year college degree, preferably in a biomedical or science related field, and at least 3 years recent experience as a Clinical Research monitor.  

To apply for a position send your resume to Jobs@JGBBioPharma.com

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220) SAS Programmer – Contract (New Jersey) 4345

DESCRIPTION:

  • Provide statistical programming expertise in SAS for the production of analyses, tabulations, graphics, and listings from clinical trial data. 
  • Contribute to the preparation of analysis plans. 
  • Prepare, document and test required programs and procedure data displays in an efficient manner for inclusion in integrated clinical, statistical reports and other similar reports. 
  • Contribute to the integrated clinical/statistical report and other similar documents. 
  • Ensure analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming and reporting. 
  • Perform quality assurance procedures on work performed by others. 
  • Develop, test, validate, document, maintain and execute software and/or systems using the currently endorsed tools or support of production activities. 
  • Assist in the integration of data from remote entry sites, contract organizations and co-licensing partners to the central database. 
  • Therapeutic area is internal medicine

EXPERIENCE AND QUALIFICATIONS:

  • Understands the basic skills and goals of reporting clinical data. 
  • Writing knowledge of SAS; SQL and UNIX. 
  • Proven ability to organize workload and priorities and complete tasks on time. 
  • Demonstrated ability to work effectively in a team environment. 
  • Strong interpersonal skills and ability to communicate effectively. 
  • Ability to identify and solve technical problems. 
  • Experience in CDISC Version 2,3 preferred. 
  • Strong experience in SAS analytical database design a MUST
  • Must have a science degree and 2+ years working in a pharmaceutical / research environment. 
  • Advanced degree in Science or Mathematics

To apply for a position send your resume to Jobs@JGBBioPharma.com

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221) Clinical Database Programmer – Full Time Position (New York / New Jersey) M100PT

DESCRIPTION:

  • Accountable for the timely production of clinical database structures, clinical data logic checks, clinical data extraction programs and tools and the conversion of clinical views to extraction datasets for multiple uses.
  • Corresponding Process Diagrams for Electronic Data Capture (EDC) studies)
  • Database programming, including the creation and implementation of eCRF behaviors, validation and derivation procedures and complex data logic checks/programs electronic case report forms (eCRF) (process diagrams for eCRF Design and Set-up and eCRF Updates)
  • Evaluates and manages changes to eCRF / database programming as a result of study change requests or UAT findings.
  • Presents eCRF update options to the SMT.
  • Sets up and manage data extraction (process diagrams for Data Extraction, Final Extraction and Unblinding, Set-up for Data Extraction and EDC file transfer protocol (FTP) Accounts for Data Extracts)
  • Develops, tests and reviews extraction programs, based on user requirements, for reporting and statistical analysis
  • Develops and maintains custom outputs for multiple uses (e.g. medical data review, clinical study reports)
  • Trouble-shoots and contributes to the resolution of data loading and extraction issues
  • Implements software programming standards (e.g. study data tabulation model (SDTM).
  • Communicates effectively with members of the study management team (SMT) to ensure that assigned study-level reporting requirements are clearly communicated and agreed upon
  • Liaises with colleagues for consistent approach to modeling and extraction
  • May participate in SMT and other meetings as needed
  • May be required to give presentations on functional topics

EXPERIENCE AND QUALIFICATIONS:

  • College/University degree in science or computer-related subject with significant bioinformatics content or two or more years experience in handling biomedical data using programming languages such as PL/SQL, C# or SAS.
  • 5+ to 7 years of experience. 
  • Bachelor's Degree.
  • Willingness to travel occasionally.
  • Demonstrated knowledge of programming Clinical Data Management applications with experience of relational databases most specifically with RAVE.
  • Good written and verbal English communication skills demonstrated by an ability to present clear instruction/direction to individuals and teams.
  • Experience of working as part of or leading a team with a proven ability to make an active contribution to the team's performance. 
  • Ability to communicate clearly with technical and non-technical colleagues.
  • Good presentation skills

 

To apply for a position send your resume to Jobs@JGBBioPharma.com

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222) Human Resources Assistant – Full Time (San Francisco Bay area)

DESCRIPTION:

  • Set up and confirm candidate interviews with clients
  • Post job advertisements
  • Update company applicant tracking system
  • Find and submit qualified candidates for open positions in the client facilities. 
  • Must have exceptional interpersonal skills to manage the recruitment database, post jobs, generate leads, pre-screen and follow-up with candidates.
  • Other tasks as needed

EXPERIENCE AND QUALIFICATIONS:

  • Excellent computer skills: Applicant tracking systems; database experience, Microsoft Word, Excel, Outlook
  • Bachelor’s degree strongly preferred -- BS/BA in Biology or Life Science preferred.
  • Must be self-motivated, present well and be able to develop relationships with candidates and individuals at all levels of the of the organization.
  • Ability to navigate through change and demonstrate flexibility as organizational needs shift.
  • Excellent organizational skills and the ability to work independently are extremely important.
  • Must live in the United States or Puerto Rico and have U.S. work status.  San Francisco Bay area preferred.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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223) Internal Auditor III (Finance) – Full Time Position (San Francisco Bay Area) H95TJ

DESCRIPTION:

  • Conducts internal financial audits and risk assessments. 
  • Performs and documents financial records for integrity and transaction accuracy. 
  • Identifies control and process deficiencies and reports discrepancies. 
  • Prepares audit plans and understands the specific issues to be evaluated. 
  • Executes internal audits of established business process controls. 
  • Develops formal written reports to communicate audit results to management and makes recommendations as appropriate. 
  • May facilitate work of external auditors during on-site visits. 
  • Requires audit knowledge and skills in finance/accounting and/or information system operations.
  • Up to 25% international travel may be required.

EXPERIENCE AND QUALIFICATIONS:


  • 3-5 years current experience in a Big 4 Accounting Firm or second tier firm.
  • Forensic accounting experience is a plus.
  • Finance investigation experience is a plus.
  • CFE, CPA or CIA certifications a plus.
  • Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, and PowerPoint. Experience with SAP ERP software desired. 
  • Domestic and possibly international travel will be occasional.
  • Bachelors degree and 5 years of related experience or Masters Degree with 3 years of related experience.


To apply for a position send your resume to Jobs@JGBBioPharma.com

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224) CRAII / Senior Clinical Research Associate II (SCRA) – Full Time Position (San Francisco Bay Area) B111CR

DESCRIPTION:

  • Reports to Clinical Program Manager (CPM).
  • May review and edit documents including protocols, informed consents, case report forms, monitoring plans, edit specifications, abstracts, presentations, manuscripts and clinical study reports
  • May write protocols and protocol amendments, with supervision
  • Will present at investigator meetings
  • May manage CROs and/or contract CRAs with guidance from CPM
  • Chair or participate in meetings or conference calls with CROs and multi-disciplinary study team
  • Assist in review of data and preparation of safety, interim and final study reports, and resolution of data discrepancies
  • Assist in setting and updating study timelines
  • Participate in abstract preparation, presentation preparation and manuscript development
  • Train clinical site staff to ensure protocol and regulatory compliance. May assist in training CRA I and CRA Assistant

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor’s degree in a relevant scientific discipline or equivalent
  • At least 3 years Clinical Operations Pharmaceutical experience for CRAII; and at least 5.5 year of relevant experience as a CRA in the biotech / pharmaceutical (not diagnostics / device) industry in an in-house (not Regional monitor, CRO or Hospital / Site based position) for SCRA.
  • Phase 3 experience, Study start-up experience, and Global trial experience are desirable
  • Must have some experience with direct monitoring of sites (in order to manage the CRO; direct monitoring is not part of this job)
  • Experience in a start-up environment preferred
  • Knowledge of GCP and ICH guidelines
  • Ability to work collegially within a team
  • Able to perform routine assignments with general instructions and new assignments with detailed instructions
  • Must be able to go on occasional travel (this is an in-house position so very little travel is expected)
  • Proficiency with MS Word, Excel, Outlook, and PowerPoint
  • Basic Relocation Provided

To apply for a position send your resume to Jobs@JGBBioPharma.com

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225) Recruiting Coordinator – Contract to Full Time (San Francisco Bay Area)

DESCRIPTION:

  • Drive, coordinate, and facilitate overall Talent Acquisition processes.
  • Manage special projects as necessary to ensure consistency among two separate operating entities.
  • Schedule interviews (in person, phone, videoconference) and may gather feedback from candidate
  • Help with recruiting and sourcing efforts for specific jobs
  • May perform other related duties as required and/or assigned.

EXPERIENCE AND QUALIFICATIONS:

  • Interacts with all levels of personnel in and outside of the company.
  • Excellent written and oral communication skills.
  • Ability to interface with varying personal styles in an effective way.
  • Good judgment, tact and diplomacy with internal and external customers.
  • Ability to handle confidential and proprietary information.
  • Must possess self-motivation, enthusiasm, and a positive demeanor toward the job, the company and their work team.
  • Effectiveness in this role requires a functional knowledge of corporate operations and product line.
  • The job encounters recurring work situations with occasional variations from the norm, involving a moderate degree of complexity.
  • Accuracy is required in performing all functions of this position. 
  • Initiative and organization skills are extremely valuable to ensure a smooth office operation. 
  • The incumbent normally receives no instruction on routine work, general instruction on new assignments.
  • Excellent computer skills
  • Recent graduate with a bachelors degree in Science or Human Resources preferred

To apply for a position send your resume to Jobs@JGBBioPharma.com

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226) Associate Director – Full time Position (San Francisco Bay Area) Y132Q

DESCRIPTION:

  • Lead functional work process optimization, continuous improvement, and change management in partnership with Clinical Operations leadership team colleagues [Study Management, Site Contracting, and Clinical Monitoring] for global clinical trials.
  • Line management of CTA Manager(s),Clinical Trial Associates (CTAs) , and other functional members as needed
  • Provide leadership, operational expertise and guidance as a point of escalation for clinical operations coordination issues.
  • Ensure that employees complete assigned project tasks on schedule and meet/exceed the expectations of that project.
  • Performance management: Tasks include and are not limited to: setting/communicating performance standards; performing ongoing performance management activities including individual goal setting/periodic performance assessments/timely performance feedback/coaching/development planning; and tracking and monitoring attendance/timesheets/expense reports. Identify and address performance issues and training needs.
  • Develop and track FTE resourcing requirements and participate in headcount planning.
  • Lead interviewing, hiring, training, mentoring, and personnel development activities within area of functional responsibility.
  • Interact with Study Teams to ensure consistent functional performance and quality of work.
  • Strategically assess metrics and ensure implementation of appropriate measures as necessary to support project or program targets / deliverables.
  • Lead strategic planning and process development/ implementation for the function(s), tracking timelines to remain on schedule, and developing contingency strategies, if needed.
  • Ensure GCP/ICH and Standard Operating Procedures (SOP) compliance and implementation across clinical trials.
  • Lead/participate in meetings to plan and implement cross-functional operational activities to increase quality, productivity, and efficiency within Clinical Operations.
  • Ensure effective and efficient collaboration between internal customers and external providers (CROs). Liaise with internal (Study Management, Site Contracting, Central Services, etc.) and external (investigational sites and vendors) partners/stakeholders to assess functional team processes/performance and opportunities for development/enhancement.
  • Collaborate and work effectively with other functional managers to establish high quality and efficient processes and ensure consistency and alignment throughout the team.
  • Maintain clear lines of communication with functional managers to ensure high quality deliverables are met.

EXPERIENCE AND QUALIFICATIONS:

  • BA/BS or equivalent degree in life sciences or allied health field.
  • Minimum of 8 years experience in clinical operations roles, including at least 3 years of global clinical trial experience. Oncology or other complex clinical indication experience required.
  • Phase 2 or 3 experience required.
  • Line management experience preferred.
  • Excellent people interaction and communication skills, strong professional diplomacy and positive attitude a must.
  • Ability to foster a collaborative team environment, motivate others, work in teams in a matrix environment and with various levels both within company and with vendors as appropriate.
  • Excellent problem solving ability, detail oriented, excellent organizational skills, ability to multi-task, re-prioritize duties, and work effectively in a fast paced matrix environment.
  • Demonstrated competency in leading cross-functional process improvement efforts.
  • Demonstrated leadership and management skills, prior supervisory experience with demonstrated success in managing people, and expertise in mentoring and coaching.
  • Financial budgeting and resourcing planning skills.
  • Solid knowledge of ICH/GCP, regulatory guidelines/directives and drug development process. Knowledge of medical terminology.
  • Strong computer skills to include MS Office: Word, Excel and PowerPoint.
  • Excellent oral/written/presentation – communication skills.
  • Cross-functional and cross-cultural awareness.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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227) Equipment Maintenance Technician – Contract (Massachusetts) 6800B73

DESCRIPTION:

  • Repair and maintain plant machinery and equipment such as agitators, pressure vessels and pumps.
  • Perform preventative maintenance and work order repairs, inspections and adjustments.
  • Repair or replace control devices such as switches, photo eyes, proximity sensors, pushbuttons, etc. as needed.
  • Responsible for 24-hour emergency maintenance service as scheduled.
  • Assist in monitoring all work being performed by outside contractors.
  • Participates in plant safety, health and environmental programs.
  • Ensure compliance of all work related activities in a fair, ethical, and consistent manner.
  • Maintain a professional courteous manner with all vendors, contractors, and fellow employees.
  • Special projects and other responsibilities as may be determined.

EXPERIENCE AND QUALIFICATIONS:

  • Expertise and proficiency with basic office computer software, and the ability to learn how to effectively use maintenance software to input data and research parts.
  • The employee must regularly lift and/or move up to 50#.
  • Must be able to climb ladders and work at elevations.
  • Have at least 3 years experience with hydraulics, pneumatics, mechanics and basic electrical repair.
  • Ability to read and interpret documents and drawings.
  • Ability to write detailed repair reports as well as good verbal communication.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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