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

2) Project Technical Coordinator – Contract (New Jersey) 6324

3) Executive Associate – Contract (New Jersey) 6170

4) Bioinformatics Scientist – Full Time (New York) GP143V

5) Project Management – Contract (Southern California) 4053S73

6) Administrative Assistant – Contract (Pennsylvania) 2954

7) Receptionist – Contract (Massachusetts) 2731

8) Statistician – Contract (New Jersey) 8588

9) Associate Scientist II - R&D – Contract (San Francisco Bay Area) 4504Q73

10) Regulatory Data Specialist – Contract (Pennsylvania) 4135

11) National Education Manager – Contract (New Jersey) 2720

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

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

14) Coordinator – HR – Contract (New Jersey) 3843

15) Marketing Assistant – Contract (San Francisco Bay Area) 73G1800

16) Director, Regulatory Affairs, CMC – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) GT113F

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

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

19) Preclinical Project Manager – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) LT132W

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

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

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

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

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

25) Data Entry Specialist – Contract (Massachusetts) 2817

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

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

28) Process Engineer - 1 – Contract (Pennsylvania) 8151

29) Executive Assistant – Full Time (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) RL142X

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

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

32) Clinical Study Director – Contract (Massachusetts) 6296

33) Coordinator - HR – Contract (New Jersey) 3746

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

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

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

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

38) Compliance Specialist – Contract (New Jersey) 0077

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

40) Admininistrative / Professional – HR – Contract (New Jersey) 7541

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

42) Senior Scientist – Analytical Chemistry – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) A106JY

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

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

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

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

47) Coordinator - HR – Contract (New Jersey) 4807

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

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

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

51) Research Associate 1 – 6 Month Contract (San Jose Area) A132FV

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

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

54) Associate CMC Director, Regulatory Affairs – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) A113HN

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

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

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

58) Marketing Development Manager – Contract (San Francisco Bay Area) 73Y1848

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

60) Packaging Technician – Contract (Pennsylvania) 9389

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

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

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

64) Statistician – Contract (New Jersey) 7443

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

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

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

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

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

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

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

72) Financial Analyst – Contract (Southern California) 8974V73

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

74) Scientist – Contract (San Francisco Bay Area) 73M3470

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

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

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

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

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

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

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

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

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

84) Scientist (BS or MS) – Contract (Pennsylvania) 1041

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

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

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

88) Coordinator – Contract (Pennsylvania) 2547

89) QC Associate 1 – Contract (Maryland) 4008H73

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

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

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

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

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

95) Chemical Engineer – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) H111BC

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

97) Scientist / Senior Scientist, Analytical Development (Biologics) – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) G111RY

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

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

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

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

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

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

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

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

106) Director / Sr. Director, Regulatory Affairs – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) G129FS

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

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

109) Technical Writer – Contract (Pennsylvania) 4062

110) Associate Director QC Team Lead – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) A131AF

111) Training Coordinator – Contract (New Jersey) 5114

112) Patent Attorney, Director – Full Time (New York) XA130J

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

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

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

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

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

118) Clinical Project Manager – Full Time Position (San Francisco Bay Area) Z82GN

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

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

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

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

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

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

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

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

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

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

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

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

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

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

133) Professional Discovery Research – Contract (Massachusetts) 2464

134) SCRA – Contract or Full Time (San Francisco Bay Area) R82BW

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

151) Scientist (BS or MS) – Contract (Pennsylvania) 0487

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

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

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

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

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

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

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

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

160) Sr. Director, Clinical Quality Assurance – Full Time Position (San Francisco Bay Area) XR96B

161) Sr. Director, Clinical Quality Assurance – Full Time Position (San Francisco Bay Area) XR96B

162) Consulting Ontologist – Contract (San Francisco Bay Area) FR103P

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

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

165) Clinical Trial Manager – Full Time Position (San Francisco Bay Area) T96NH

166) Senior Clinical Research Associate / Clinical Trial Manager – Full Time Position (San Francisco Bay Area) MJ96F

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

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

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

170) Associate Director, Clinical Data Management – Full Time Position (San Francisco Bay Area) XT96G

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

172) IT Technical Writer – 6 month contract (San Jose Area) N96GB

173) ERP Finance / IT Analyst – Contract or Full Time Position (San Francisco Bay Area) GN96Q

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

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

176) General Warehouse Worker – Contract (Pennsylvania) 5225

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

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

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

180) SAS Programmer – Contract (New Jersey) 4345

181) Scientific Marketing Specialist – Contract (Southern California) 73T7776

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

183) (Senior) Clinical Trial Manager – Full Time (San Francisco Bay Area) R96TW

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

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

186) CRAII / Senior Clinical Research Associate II (SCRA) – Contract or Full Time Position (San Francisco Bay Area) B80CR

187) Clinical Program Manager – Full Time Position (San Francisco Bay Area) R80BS

188) Biotechl Recruiter / Sourcing Specialist – (Full Time or Part-time, San Francisco Bay area preferred)

189) Clinical Laboratory Scientists (CLS)/Research Associate (RA) – Full Time Position (San Francisco Bay Area) BD64G

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

191) Packaging Technician – Contract (Pennsylvania) 3156

192) R&D Software Developer Medical Technology – Full Time or Contract Position (San Francisco Bay Area) L74HT

193) Clinical Laboratory Scientists (CLS)/Research Associate (RA) – Full Time Position (San Francisco Bay Area) BD64G

194) Senior/Associate Director Program Manager – Full Time or Contract (San Francisco Bay Area) P73BY

195) R&D Software Developer Medical Technology – Full Time or Contract Position (San Francisco Bay Area) L74HT

196) Paralegal/Contracts Associate – Part Time Position 20 Hrs/week (San Francisco Bay Area) YR90W

197) Manager, Sr. Manager, Regulatory Affairs CMC – Contract or Full Time Position (San Francisco Bay Area) Q77AB

198) (Senior) Reliability Engineer Manufacturing & Production/ Industrial Manufacturing – Full Time Position (San Francisco Bay Area) S62BA

199) EBM Biostatistician - Senior – Contract (New Jersey) 5863

200) Senior Statistical Analyst/ Manager, Statistical Programming – Full Time Position (San Francisco Bay Area) JM96B

201) Associate Director/ Principal, Biostatistics – Full Time Position (San Francisco Bay Area) F96MP

202) Administrative Assistant – Executive – Contract (New Jersey) 0203



1) 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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2) Project Technical Coordinator – Contract (New Jersey) 6324

DESCRIPTION:

  • Support the activities in the department and the capacity management team
  • Support ACTIME Timecard Management, act as the Timecard Manager for the CSO departments
  • Support ACTIME CSO monthly compliance reports and analyses
  • Assist in maintaining the database, reconciliations and various HC reports and ad hoc analyses
  • Maintain and update necessary data; assisting with the preparation and coordination of essential tracking systems within department.
  • Ad-hoc operational & financial analyses

EXPERIENCE AND QUALIFICATIONS:

  • Strong computer skills including MS Word, Excel and PowerPoint, and Outlook are required, especially Excel.
  • Ability to collect, analyze and report on data
  • Ability to interface with internal customers to assist with system questions
  • Ability to work well as an individual or as part of a team.
  • Excellent communication, interpersonal, and organizational skills are required.
  • Ability to handle confidential information.
  • Ability to meet and manage changing priorities in a fast-paced global environment.
  • Ability to learn and use new tools (software, tracking systems, Internet search)
  • Minimum 5 years of equivalent experience, some post high school education preferred

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

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3) 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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4) 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 preferred   
  • Proficiency in Python, Perl, Java, C/C++, and R programming
  • Good working knowledge of current best practices in genetic variant discovery and validation methods
  • 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 roll up their sleeves and do what it takes to get the job done
  • 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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5) Project Management – Contract (Southern California) 4053S73

DESCRIPTION:

  • Assist in developing and executing the communications plan, including identifying deliverables, roles, responsibilities and timelines.
  • Conduct preliminary reviews of deliverables to ensure requirements are met
  • Staying close with responsible parties to track against deadlines
  • Routing deliverables through review processes and ensuring timely review and follow-up; answering questions and incorporating required changes into communication deliverables.
  • Independently assess problems, develop solutions and recommend a course of action consist with the business need.
  • Manage planning, logistics and execution of communication distribution.
  • Manage document/deliverable versions and create archive of final deliverables.
  • Establish and maintain effective working relationships with subject matter experts and other key constituencies.
  • May be required to perform other related duties as required and/or assigned.

EXPERIENCE AND QUALIFICATIONS:

  • The ideal candidate would be one with 2-3 years of communications experience in a corporate environment, with demonstrated strong organizational skills.
  • Requires 2-3 years of professional experience, with demonstrated understanding of organizational communication principles and success managing a complex project or multiple simultaneous projects.
  • Exceptional organizational and project management skills. 
  • Exceptional business writing skills, with a demonstrated understanding of organizational communication practices.
  • Advanced user of Microsoft Word, PowerPoint and Excel. 
  • Ability to assess a problem, develop a range of solutions, and present and defend a recommended course of action.
  • Anticipates needs and problems while creating solutions.
  • Adaptable, comfortable with frequent change
  • Requires a bachelor’s degree and/or equivalent experience/training.

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

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6) Administrative Assistant – Contract (Pennsylvania) 2954

DESCRIPTION:

  • This position is generally administrative and covers a wide range of activities and assigned tasks.  
  • Multiple demands are common and require a high degree of flexibility, judgment, and organizational & technical skills.  
  • Maintain sufficient knowledge to enable independent fulfillment of job responsibilities.  
  • Prepare and process departmental paperwork, correspondence, presentations, reports, budgets, expense reports, travel requests.  Review and refer responses to incoming email, mail and phone calls.  Order office supplies, as required.  Set up and maintain document files, including databases.
  • Prepare and submit purchase requisitions on behalf of the Project Management group.  Manage purchase orders.  
  • Requires expert knowledge of the NEXTS procurement system and work processes.
  • Work with the Project Management group to receive invoices in the system.  Manage invoices.
  • Requires a basic understanding of the accounts payable process.

EXPERIENCE AND QUALIFICATIONS:

  • At least 5 years work experience as an administrative assistant required.  
  • Experience with Microsoft Office  including MS Outlook, Word, Excel, PowerPoint.  
  • Excellent oral and writing skills
  • Proven ability to work independently, highly organized and effective in handling multiple detail-oriented projects in a fast-paced environment. 
  • Must exercise discrete and judgment in handling confidential/proprietary information.
  • Ability to anticipate needs, resourcefulness and responsiveness are essential.
  • Attentive to details and results.
  • High school graduate minimum requirement
  • Qualified college graduates desired

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

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7) Receptionist – Contract (Massachusetts) 2731

DESCRIPTION:

  • Multi-tasking at an energetic office daily with many interruptions
  • Responsible for all phone calls at the main desk
  • Meet and greet guests. Pre-register guests for employees and register in-coming guests, and notify employees
  • Manage 6 conference room calendars via Outlook
  • Keep conference rooms clean and professional
  • Maintain copier, outgoing and interoffice mail, and fax machine
  • Handle daily in-coming US Postal mail distribution
  • Maintenance of general coffee area
  • Liaison for employees and vendors/service technicians
  • Go-to person for miscellaneous issues

EXPERIENCE AND QUALIFICATIONS:

  • Highly organized receptionist/administration assistance  
  • Adept at handling multiple projects simultaneously with equal competency. 
  • Able to communicate effectively and promote positive image in all interactions, internal and external. 
  • Computer skills/applications:  Outlook, Word
  • BA or similar.   
  • At least five years’ experience as receptionist or admin.

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

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8) Statistician – Contract (New Jersey) 8588

DESCRIPTION:

  • Draft or review protocol and statistical analysis plan for HEOR studies, execute the analysis, interpret the findings and generate the report, support internal communication and scientific publication
  • Conduct retrospective database study for disease burden or comparative effectiveness, post-hoc analysis of randomized clinical trial, predictive modeling, and indirect treatment comparison with appropriate analytic methods  
  • Stay ahead of HEOR methodology development and develop programs to implement novel methods under the guidance of team lead
  • Prepare, verify, and manage research data sets from administrative health insurance claims, electronic medical record databases, randomized clinical trials, or other sources as per project specifications
  • Conduct analytic quality assurance procedures and ensure quality of final deliveries

EXPERIENCE AND QUALIFICATIONS:

  • Solid background on statistical modeling methods and simulation
  • Experience with conducting HEOR studies and ability to work independently under general guidance
  • Working knowledge of healthcare industry, drug development and reimbursement requirements
  • Strong hands-on experience with standard software package as SAS, knowledge of R, OpenBUGS, VBA or other analytic software is a plus
  • Ability to plan, organize, and work on multiple tasks simultaneously and in multidisciplinary teams.
  • Self-motivated with ability to meet deadlines
  • Advanced degree in statistics, econometrics, psychometrics, or related quantitative sciences plus >4 years of relevant experiences

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

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9) Associate Scientist II - R&D – Contract (San Francisco Bay Area) 4504Q73

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 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:

  • Must have experience in laboratory experiment operation. 
  • Experience with DNA sequencing and qPCR instruments
  • Excellent data analysis skills are required. 
  • Proficiency in one or more analysis tools such as Matlab, Perl, Python, VB, etc. is preferred.
  • Must have strong communication skills and the ability to work independently. 
  • Must be able to develop and characterize measurement systems.
  • Formal experimental design and statistical analysis skills are plus.
  • 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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10) Regulatory Data Specialist – Contract (Pennsylvania) 4135

DESCRIPTION:

  • Document management support and data entry/review.
  • Work with the site regulatory product management to update licensing commitment documents to support industrial operations.
  • Update existing documentation into a new template aligning information with country specific licenses, route for review, track and incorporate comments and route for final approval.
  • Individual will act as a liaison between Regulatory Affairs and Industrial Operations.

EXPERIENCE AND QUALIFICATIONS:

  • Working knowledge of Adobe Acrobat and Word a must.
  • Technical writing skills will be useful.
  • Prior work in pharmaceutical regulatory affairs and/or pharmaceutical quality industry is a must
  • Project management experience is desired
  • Individual must be able to work independently
  • Associate degree or higher with 3-5 years experience with data management.

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

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11) National Education Manager – Contract (New Jersey) 2720

DESCRIPTION:

  • Possess an ability to assess clinical data and educational needs across therapeutic areas (e.g. Diabetes, Oncology) to support Medical Units in the development of a high quality, innovative and strategic medical education plans.
  • Collaborate with associates in the North America Medical Affairs organization to ensure development of fully integrated strategies and tactics.
  • Participate in the review and critique of educational grant applications for compliance with regulatory requirements, company policy and alignment with education strategies.
  • Critically evaluate budgets for proposed education activities and liaise with procurement and finance as needed.
  • Participate in the development and management of the budget for overall education plans, including providing regular updates, tracking and modifications as required with one or more therapeutic areas.
  • Critically evaluate education providers for capacity to develop highest quality, innovative CME programming consistent with principles of adult learning.
  • Assess education providers to ensure that medical education activities are of the highest scientific rigor, educationally well designed and delivered in a timely, cost-efficient manner and in compliance with regulatory requirements.
  • Support the maintenance of IME/CME competitive intelligence and program monitoring and evaluation.
  • Collect and analyze educational outcomes from funded activities; Monitor appropriate overall metrics and effectiveness measures and communicate results to internal stakeholders. 
  • Maintain an accurate and current database on the status of all projects as assigned.
  • Participate in cross-functional teams and ensure working teams meet frequently to evaluate educational programs and provide feedback

EXPERIENCE AND QUALIFICATIONS:

  • Knowledge and experience in medical education (5 years minimum)
  • Pharmaceutical Industry experience (5 years)
  • IME/CME Subject Matter Expert (grant review process, request for Proposal development and education expert)
  • Strong oral and written communication skills
  • Knowledge of applicable rules and regulations: ACCME, OIG, PhRMA, AMA
  • Understanding of highly regulated pharmaceutical industry environment
  • Ability to initiate and maintain relationships cross-functionally
  • Demonstrate functional knowledge of medical education of applicable guidelines including ACCME, OIG, PhRMA, FDA, etc
  • Advanced college degree in a scientific discipline preferred (i.e. PharmD; PhD, etc.)

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

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12) 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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13) 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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14) Coordinator – HR – Contract (New Jersey) 3843

DESCRIPTION:

  • Coordinates multiple calendars, travel itineraries and maintains associated records.
  • Schedules appointments and arranges travel at the VP’s request.
  • Coordinates all logistics for meetings and conference calls as necessary to include preparation of agenda and all materials pertinent to the meetings.  
  • Responsible for all correspondence.
  • Assists with preparation of expense reports for the comp and benefit teams.
  • Processes and distributes incoming and outgoing mail.  
  • Maintains confidentiality of mail. Updates name/address information as needed. 
  • Answers VP’s telephone and/or greets visitors in a courteous and timely manner as requested.
  • Provides administrative support 
  • Maintains filing and record keeping system
  • Serves as liaison between VP/HR and Ccients 
  • Displays a high level of effort and commitment to performing work; operates effectively within the organizational structure; demonstrates trustworthiness and responsible behavior. 

EXPERIENCE AND QUALIFICATIONS:

  • At least 3 years’ experience performing advanced level administrative support.  
  • Excellent knowledge and advanced skills in the use of the, Internet, Outlook, Microsoft Word, Excel and PowerPoint.  
  • Must be strong in both oral and written communication.  
  • Organizational skills a plus

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

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15) Marketing Assistant – Contract (San Francisco Bay Area) 73G1800

DESCRIPTION:

  • Contributes to the success of generating demand, supporting the global brand and determining optimal channel utilization. 
  • Become familiar with the needs, and driving influences of the biotechnology customer, and biotechnology industry, respectively; from both a product and marketing message standpoint. 
  • Help execute and perform subsequent analysis of data from marketing campaigns, from which the preparation of reports and recommendations for future ventures might be required. Interact frequently with the sales team, addressing account specific needs and campaigns if required. 
  • Understands analytical, operational, marketing or technical concepts. 
  • Predominately works on tasks/duties that are considered relatively routine to diverse in nature, using developing technical and/or business knowledge. 

EXPERIENCE AND QUALIFICATIONS:

  • Excellent verbal and written communication skills required
  • Strong communication and presentation skills 
  • Ability to develop and execute plans in a self-sufficient manner
  • Ability to work effectively in a changing environment, able to deal with ambiguity, strong initiative, willingness to take ownership and drive a project to completion 
  • Progressive thinker, able to integrate best practices 
  • Willing to challenge the status quo 
  • Attention to detail, strong follow-through
  • Requires a BA or BS in a life science discipline or equivalent experience.

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

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16) Director, Regulatory Affairs, 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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17) 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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18) 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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19) Preclinical Project Manager – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) LT132W

DESCRIPTION:

Coordinate, track, monitor, update and follow-up on new or ongoing Material Transfer Agreements (MTA)s and Sponsor Research Agreements (SRA) submitted for review.  Includes working closely with contract /legal and Research team in supporting the online submission portal and external business colleagues/external investigators.  Facilitates MTA/SRA concept submissions and material transfer to external collaborators, and the internal evaluation, reviews and approval/rejection process.  Coordinates meetings with academic collaborators, documents decisions and updates all preclinical research collaborations keeping track of progress and material transferred.  In addition, build organization and keep track of external preclinical studies performed at CROs.
 
Responsibilities:
  • Responsible for collection and initiating review of MTA/SRA requests from external collaborators
  • Responsible for initiation of project review, maintenance, follow-up and termination of MTA/SRAs working with legal/contracts and research teams.
  • Responsible for material transfer, fund transfer and documentation, communication with collaborators in regards to MTA/SRA.  Keep SRAs within yearly Research collaboration budgets.
  • Responsible for summarizing and updating all active MTAs/SRAs and maintaining soft and hard copies of communications of all collaborations.  Monitor and track progress of collaborations and provide status update reports
  • Establish and manage project timelines and responsible for coordinating documentation
  • Coordinate the review of submitted MTA/SRA concepts, manage the agenda and provide approved minutes for the Joint MTA review teams.
  • Establish or initiate and maintain documentations, reports for preclinical and research external studies with external vendors or collaborations.
  • Arrange meetings with investigators and/or vendors.
  • Keep track of research and preclinical department budgets

EXPERIENCE AND QUALIFICATIONS:

  • Demonstrated experience in managing multiple projects
  • Ability to exercise independent judgment within generally defined practices and policies that lead to processes for achieving results
  • Excellent organization, planning and writing skills
  • A bachelors degree in scientific fields necessary
  • Strong interpersonal skills and communication skills (both written and oral)
  • Ability to problem solve as needed to meet deadlines
  • Self-motivated, adaptable to a dynamic environment
  • Able to collaborate effectively with cross-functional team members, and external partners
  • Proficiency in MS Word, Excel, PowerPoint, and MS project
  • Pharmaceutical experience
  • Experience in multi-functional coordination or tracking of reports is a plus
  • BA/BS required, Biological or Medical Science degree preferred.
  • Advanced degree a bonus.

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

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20) 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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21) 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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22) 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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23) 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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24) Clinical Regulatory Affairs, 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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25) Data Entry Specialist – Contract (Massachusetts) 2817

DESCRIPTION:

  • Responsible for accurate and timely entry of patient demographic and financial information into department database for assistance applications and insurance verifications for a high volume reimbursement and patient support team.
  • Accurately review customer requests from an Outlook fax inbox, determine the most appropriate service required, and triage the request accordingly.
  • Fax, email, and mail letters to customers in response to assistance requests
  • Provide back up support to Administrative Assistant for triaging the team voice mails to appropriate Case Managers.
  • Assist with data clean up projects and other department projects as needed.

EXPERIENCE AND QUALIFICATIONS:

  • Spreadsheet and database skills
  • Proficient typing skills reflecting accuracy and speed
  • Experience working in a team environment
  • Ability to work independently
  • Strong communication skills; ability to thrive in a team environment
  • Well organized with a strong attention to detail
  • Consistently meets established deadlines
  • Preferred Bachelor or Associate’s Degree preferred
  • SalesLogix database experience preferred
  • Basic understanding of health insurance benefits and reimbursement preferred

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

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26) 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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27) 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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28) Process Engineer - 1 – Contract (Pennsylvania) 8151

DESCRIPTION:

  • Expected to develop an understanding of the basic process chemistry of the manufacturing process and leverage this knowledge to support implementation of process changes, developing solutions to non-conforming performance, and identification of opportunities for improvement.
  • Deliver solutions for improving the end to end aspects of the manufacturing process, including the validated processes, raw materials, and design requirements for manufacturing equipment.
  • Participate on cross-functional project teams in the planning and execution of project deliverables including engineering, investigational, or process validation runs as required.
  • Execute developmental studies and technical assessments in support of troubleshooting or improving processes.  Document and interpret study results providing recommendations back to project team and management. 
  • Generated developmental, validation, and change control documentation as required.
  • Facilitate process monitoring, trend analysis, and investigations required for the completion of project deliverables.
  • Manage project timelines to ensure deliverables are met on time and on budget.
  • Project work must be conducted with minimal oversight from the area technical lead, and requires successful application of scientific problem solving skills.  The candidate will also be required to obtain a basic working knowledge of company-specific systems, standards, and procedures.  Periodic checks and reports are required to review soundness of technical judgment and the status/schedule of the effort.

EXPERIENCE AND QUALIFICATIONS:

  • Degree in engineering or scientific discipline, with experience in Vaccine, Biologic, or Pharmaceutical manufacturing or providing technical support of such processes.
  • Demonstrated interpersonal skill, including flexibility and ability to work in a team environment.  Proven analytical abilities. Demonstrated written and verbal communication skills.
  • Ability to work both independently and as part of a project team collaborating with members from Manufacturing/Operations, Manufacturing Technology, Validation, Automation and Quality.
  • Demonstrated technical problem-solving, communication, and collaboration skills.
  • Demonstrated organization skills, ability to multitask, and work in a dynamic environment

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

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29) Executive Assistant – Full Time (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) RL142X

DESCRIPTION:

  • Supports the Managing Director (MD). This includes being the initial contact for new, non-referred potential clients.    
  • Handles all scheduling and calendaring with respect to Board of Directors meetings on various Boards, Business Development breakfasts, lunches and after-hours meetings, as well as domestic and international travel.  
  • Responsible for input of MD’s billable hours including gleaning emails, voicemails, and calendar for potential lost time.  
  • Responsible for instituting a daily meeting wherein MD converses with Executive Assistant to discuss and review the previous day’s billable time as well as the dynamics of the next successive day’s schedule.  
  • Reviews voicemails and returns any applicable calls.  
  • Reviews emails and responds to any emails that require a response particularly when Director is out of the office for an extended period.  
  • Prepares for Board Meeting attendance by reviewing agenda and compiling any information that the Director must know, respond to or speak about at the meeting.  
  • Maintains Board books for various organizations which MD is a Board Member of.  
  • Assists in providing front desk relief as necessary. 

EXPERIENCE AND QUALIFICATIONS:

  • Excellent communication skills (written and verbal)
  • Excellent interpersonal skills
  • Highly organized
  • Computer proficient
  • Ability to work independently and as a team member
  • Understanding of switchboard
  • Ability to manage multiple priorities
  • Familiarity with Time Matters a plus.
  • Bachelor Degree preferred

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

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30) 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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31) 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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32) Clinical Study Director – Contract (Massachusetts) 6296

DESCRIPTION:

  • Medical reference and medical expertise for operational strategy within the CSO for study registries he/she is allocated to
  • Medical consultant for projects to be proposed to the CSO
  • Medical contact for interaction with physicians responsible for the project or the study at the customer level
  • Support with his/her medical knowledge and background a study or a project from business negotiation with customers to final product deliver y (e.g. study completion or project report or publication)
  • Conduct the feasibility for study/project with the feasibility manager and other team members (especially Medical Advisors in CSUs)
  • Prepare and/or organize and/or participate to Investigator’s Meetings, Steering Committees, Data Monitoring Committee meetings (only “open” part of the DMC meetings).
  • Prepare and/or approve any documents related to the study and requiring a medical expertise (extended synopsis, protocol, medical training material for study monitoring team and for investigators)
  • Provide medical training to study team, CSUs (Medical Advisors, monitoring) and investigators
  • Develop interaction with Medical Advisors in CSUs for the best knowledge of the study, compound protocol
  • Participate to Investigators meetings
  • Provide medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators , experts
  • Participate to clinical trial team (and cluster if any) meetings
  • Accountable for the medical review of data done by the clinical trial team, the case by case review of safety events reported to GPE and coding of events and drugs
  • Provide appropriate medical input for patient recruitment and retention strategy
  • Support the CSUs and affiliates to develop network of KOLs and experts and to select National Coordinators or members of Study Committees
  • Prepare and provide key medical information to investigators and/experts in respect with communication policies (e.g study results, DMC advice)

EXPERIENCE AND QUALIFICATIONS:

  • MD required
  • 5 or more years of Clinical Research and/or Drug Development experience in
  • Knowledge in ICH, GCP and local regulations
  • Fluent in English (writing and speaking)
  • Additional Clinical Research and/or Drug Development experience in other therapeutic areas, especially Cardiovascular

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

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33) Coordinator - HR – Contract (New Jersey) 3746

DESCRIPTION:

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

EXPERIENCE AND QUALIFICATIONS:

  • 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. 
  • 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
  • Prior experience with Taleo or other Applicant Tracking System preferred
  • Ability to work independently
  • HS Diploma Required, Associated degree preferred; 2-4 years in administrative or hospitality role.

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

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34) 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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35) 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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36) 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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37) 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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38) Compliance Specialist – Contract (New Jersey) 0077

DESCRIPTION:

  • Maintain viability and integrity of US marketed products by conducting quality reviews of labeling artwork within the interdepartmental review process as follows:
  • Provides timely review of labeling artwork to ensure final product labeling complies with FDA requirements and  corporate standards  
  • Uses both manual (visual) and software-assisted methods to perform text comparison and assures that drafted art files faithfully reproduce FDA-approved text and meet accepted standards for layout
  • Validates printer’s proofs against VISTA approved artwork using text comparison software (AutoProof Pro), also uses visual methods when needed
  • Gives final approval for implementation of artwork in Electronic Change Control System
  • Participates in weekly interdepartmental labeling meetings and obtains consensus on labeling revisions and prioritization of labeling activities
  • Discusses labeling corrections with other labeling review groups (for example, Legal, Supply Chain, Regulatory Affairs, and Marketing)
  • Gains consensus on impact and urgency of labeling corrections, negotiates implementation, and tracks eventual resolution in artwork 

EXPERIENCE AND QUALIFICATIONS:

  • Detail and quality-oriented. 
  • Excellent administrative, organizational, proofreading and communication (verbal and written) skills. 
  • Ability to independently prioritize and multitask with minimal supervision in a team-oriented, production environment. 
  • Bachelor's Degree

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

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39) 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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40) Admininistrative / Professional – HR – Contract (New Jersey) 7541

DESCRIPTION:

  • Enter talent data into e-talent tool to include but not limited to updating of key positions, succession plan charts, development groups as well as PPM matrix entry.  
  • Exporting data from the tool to quality check with community.  
  • Looking for someone with good administrative skills

EXPERIENCE AND QUALIFICATIONS:

  • Attention to detail
  • Strong data entry skills
  • Technically saavy
  • Bachelor degree preferred but not necessary.

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

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41) 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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42) Senior Scientist – Analytical Chemistry – Full Time (San Francisco/Peninsula/Marin/Sonoma/Napa/Santa Rosa/Petaluma) A106JY

DESCRIPTION:

  • Develops, plans and executes analytical chemistry activities for the company in compliance with cGMP, safety and regulatory requirements.
  • Investigates the feasibility of applying a wide variety of scientific principles and concepts to potential inventions, products and problems.
  • Conducts drug release rate and assay/impurities testing of long term/sustained release drug formulation.
  • Develops, trouble shoots and improves analytical methods and validation reports in support of regulatory submissions.
  • Takes the analytical lead on large portions of assigned projects, identifying and performing the required analytical tasks with minimum supervision in support of product development, lot release, and regulatory submission activities.
  • Participates in method transfer activities.
  • Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
  • Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.  
  • Defines complex problems, develops approach and develops experiments with sound judgment.

EXPERIENCE AND QUALIFICATIONS:

  • Experience with Agilent HPLC and data acquisition software is required.
  • Knowledge of current FDA/ICH guidelines and US Pharmacopeia is required.
  • Understanding and familiarity with analytical regulatory requirements for ANDA/NDA submission is preferred.
  • Must possess ability to work on multiple tasks in a fast paced environment.
  • Excellent hands-on laboratory skills.
  • Highly motivated & flexible team player.
  • Excellent written and verbal communications skills. 
  • Must be able to compose sound written work with no assistance.  
  • Experience in writing regulatory documents.
  • Skilled at presenting technical information to non-technical audiences.
  • Possesses sound judgment skills.
  • Expert knowledge of scientific principles and concepts.   
  • Requires an MS in a scientific discipline or equivalent with a minimum of 5 years of experience in a pharmaceutical product research, development and and manufacturing environment

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

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43) 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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44) 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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45) Sr. Director, Clinical Regulatory Affairs – 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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46) 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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47) Coordinator - HR – Contract (New Jersey) 4807

DESCRIPTION:

  • Provide administrative support to HR Business Partner teams.  
  • Assist with follow up on administrative items related to transactions, reporting, data entry related to certain HR systems. 
  • Responding to general HR related items on behalf of HR Business Partners.  
  • Addressing calls from Client Groups on a variety of Human Resource Policy and Procedures. 
  • Setting up and organizing meetings in Outlook, providing teleconference call-in numbers, booking conference rooms, and ordering audio/visual equipment. 
  • Manage department's Outlook calendars, rescheduling conflicts when necessary. 
  • Creatively enhance PowerPoint presentations. 
  • Gather data for Excel spreadsheets including charts and graphs. 
  • Create mail merges and a variety of correspondence in Word. 
  • Provide back-up support for other coordinator in group.

EXPERIENCE AND QUALIFICATIONS:

  • Experience with Microsoft Word, Excel, PowerPoint, and Outlook. 
  • HR SAP database experience a plus. 
  • Previous experience supporting an HR organization is a strong plus.  
  • 3 years working in a business environment.  
  • Ability to multi-task with accuracy in a fast-paced, professional environment.
  • HS or equivalent

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

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48) 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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49) 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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50) 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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51) Research Associate 1 – 6 Month Contract (San Jose Area) A132FV

DESCRIPTION:


  • Responsible for execution of in vitro and in vivo experiments, including tissue culture, apoptosis assays, biological assays, western blotting, molecular biology and animal tumor models and generally supporting preclinical project teams in screening new compounds in cellular assays.
  • Tissue culture biological assays, molecular biology, western blotting, spectrophotometry and microscopy. Small animal tumor models. 
  • Development/execution of in vitro and ex vivo cell based assays with hematopoietic cells
  • Clinical immune-monitoring with multi-color flow cytometry methods
  • Development/execution of ex vivo PD assays
  • Monitor and order lab supplies and maintain equipment. 
  • Provide support for scientific staff.
  • Monitor and order lab supplies and maintain laboratory in functional order.
  • Responsible for presenting data in group meeting
  • Maintain records of experiments and assist with laboratory operations

EXPERIENCE AND QUALIFICATIONS:

  • Excellent written and verbal communication skills.  
  • Ability to solve problems and work in a group environment. 
  • Advanced organization skills and attention to detail skills.
  • Must have hands-on expertise in: flow cytometry (FACS), in vitro cell-based assays, molecular biology techniques, including Western blotting, ELISA, QPCR and mammalian cell culture.
  • Must be knowledgeable of use of analytical software and equipment for these methodologies.
  • Expertise in isolation of human cells and establishment of primary cell cultures is an advantage.
  • Must have excellent oral and written communication skills, must be self-motivated, highly organized, and able to work independently in a fast-paced research environment.
  • Prior industry experience is a plus.
  • 2-5 years experience with the execution of in vitro and in vivo experiments, including tissue culture, apoptosis assays, biological assays, western blotting, molecular biology and animal tumor models. 
  • BS/MS in related scientific in Biochemistry, Immunology, Cancer Biology or a related discipline.

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

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52) 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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53) 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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54) Associate CMC Director, Regulatory Affairs – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) A113HN

DESCRIPTION:

  • Will report to the Director, Regulatory Affairs, CMC
  • 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:

  • Thorough understanding of relevant drug development regulations and guidelines is essential.
  • Prior success filing marketing applications, supplements, and variations for 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%.
  • At least 2 years of previous supervisory experience managing associates is required.
  • 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.
  • 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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55) 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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56) 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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57) 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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58) Marketing Development Manager – Contract (San Francisco Bay Area) 73Y1848

DESCRIPTION:

  • Responsible for the go-to-market strategy and demand generation for products within the NGS business unit. 
  • Will help drive the development and execution of marketing programs to support a growing business unit in a dynamic market environment. 
  • The successful candidate will coordinate closely with Product Management and Regional Marketing, as well as liaison with Corporate Marketing's Studio/Design and eMarketing teams, to deliver key assets designed to help achieve global sales, marketing, and revenue goals. 
  • Will laise with internal and outside vendors, maintaining excellent professional relationships, in order to facilitate the conversion of marketing ideas and messages into effective marketing communications deliverables.
  • Help develop strategic action plans that drive growth in key segments.
  • Develop messaging & tools that communicate the value/brand to specific segments/regions.
  • Develop content for web, print, PR, etc from product specifications and technical documentation.
  • Develop innovative and impactful collateral materials.
  • Create and deliver sales tools & sales training.
  • Manage project budgets and aggressive timelines.

EXPERIENCE AND QUALIFICATIONS:

  • Exceptional communication skills as well as analytical, project management and planning skills necessary.
  • Strong business acumen, marketing experience, and customer focus are essential.
  • Knowledge of the following key competencies: 4Ps and marketing mix, marketing communication, communication channels, channels-to-market, segmentation, value proposition and marketing program development and execution.
  • Effectiveness in this role requires the ability to clearly communicate verbally and in writing product area marketing plans, and a general knowledge of operating plans as well as industry practices for promoting and selling similar products.
  • Has thorough functional understanding of the market development role and in depth knowledge of next-generation sequencing markets a plus.
  • Ability to work on problems of routine to diverse scope.
  • Identifies problems, answers questions, gains cooperation of others and implements efficient solutions.
  • Bachelor’s degree in molecular biology or related discipline with at least 3 years experience in a marketing role
  • MBA strongly preferred

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

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59) 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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60) Packaging Technician – Contract (Pennsylvania) 9389

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 and dependable.
  • Able to work independently and 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 or equivalent is required.

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

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61) 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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62) 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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63) 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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64) Statistician – Contract (New Jersey) 7443

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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65) 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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66) 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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67) 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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68) 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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69) 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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70) 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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71) 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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72) Financial Analyst – Contract (Southern California) 8974V73

DESCRIPTION:

  • Maintaining the integrity of our financial systems through reconciling EDW to Hyperion Planning and troubleshooting disconnects.
  • Responsible for the data maintenance and data integrity of Cognos EDW, and as it relates to the other systems. 
  • Participate in month end activities including data loads, variance analysis and report generation.
  • Executing month end close activities which will include loading manual entries to EDW and reconciling sales, cost, OPEX and inventory transactions.
  • Support integrations activities e.g. loading AOP and historical sales data to EDW.
  • Driving process improvements through automating manual processes and making best use of our systems.
  • Providing end user training to EDW end users within Finance.
  • Working with IT to ensure key enhancements and defects are properly tested and deployed to our live systems, ensuring data integrity by developing effective controls, identifying issues and fixing at source system.

EXPERIENCE AND QUALIFICATIONS:

  • Intermediate to Advanced skill set in MS Excel
  • Strong computer skills (e.g., MS Office, Outlook)
  • Excellent communication and interpersonal skills
  • Familiarity with a full P&L
  • Experience with data analysis to determine root cause issues and ability to resolve in a timely manner
  • Ability to multitask effectively and complete projects by set deadlines
  • Experience with financial reporting systems required
  • Experience with a data warehouse desired
  • Experience with Cognos, HFM, SAP, E1, Essbase, or SQL a plus, but not required
  • Bachelor's degree required, MBA preferred.
  • 3-5 years experience preferred in a comparable role.

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

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73) 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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74) Scientist – Contract (San Francisco Bay Area) 73M3470

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:

  • Molecular Biology skills and techniques, including but not limit to: DNA/RNA extraction, PCR, realtime PCR, reverse-transcription PCR, and solid understanding of PCR and qPCR theory and data analysis; tissue and sample manipulation and handling
  • Write clear assay development and study reports and maintain good documentation; Routine lab maintenance
  • Requires a Bachelor's degree with minimum 6 years or Master's degree with over 4 years of experience, in Molecular 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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75) 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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76) Sr QC Stabilty Associate / Manager – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) BL122T

DESCRIPTION:

  • Propose required stability protocols
  • Plan and execute analytical method transfers
  • Collaborate with contract labs to set up stability studies in compliance with FDA 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. 
  • 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. 
  • 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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77) 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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78) 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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79) 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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80) 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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81) 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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82) 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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83) 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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84) Scientist (BS or MS) – Contract (Pennsylvania) 1041

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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85) 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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86) 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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87) 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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88) Coordinator – Contract (Pennsylvania) 2547

DESCRIPTION:

  • Enter shipments into the Clinical Supplies Management System (CSMS). 
  • Enter site addresses into the CSMS 
  • Update site addresses in the 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 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:

  • Communication and interpersonal skills
  • 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. 
  • Building working relationships: 
  • 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, and 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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89) QC Associate 1 – Contract (Maryland) 4008H73

DESCRIPTION:

  • Understand the requirements for simple and complex QC testing procedures.
  • Initialize ION DX PGMs, operate Guava cutometer, HPLC
  • Stage testing materials
  • Keep inventory and order supplies and retains
  • Update existing documentation with guidance from the technical experts. 
  • Develop and document new and improved processes and scheduling methodologies.
  • Participate in continuous improvement initiatives.
  • Provide support to QC testing groups.
  • Coordinate and manage productivity projects as needed.
  • Perform final content review and transactions as necessary.
  • Record and report performance to schedule

EXPERIENCE AND QUALIFICATIONS:

  • Minimum of 1 year of sequencing experience.
  • Strong Molecular Biology laboratory skills
  • Strong communication skills
  • Advanced Excel skills
  • Must be customer focused, able to work under pressure with team
  • Anticipate needs and problems while creating solutions
  • Proven ability to consistently and independently follow policies and procedures; written and verbal instruction, and to meet schedules required
  • Working knowledge of business computer software with logistics related databases
  • Strong organizational, record-keeping, and data analysis skills
  • Bachelor or Advanced degree in Molecular Biology, Biochemistry, Bioengineering or other related discipline.

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

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90) 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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91) 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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92) 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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93) 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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94) 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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95) Chemical Engineer – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) H111BC

DESCRIPTION:

  • Reporting to the Department Senior Director, the successful incumbent will focus on process safety, scale up manufacturing and process validation associated with new small molecule pharmaceuticals
  • Working in multi-functional teams to develop scalable processes which supplies API for safety testing, clinical trials and formulation development.
  • Supporting API projects through all phases of development (Phase I to Process Validation including commercial manufacturing).
  • Assisting in oversight of CMO activities related to technology transfer, optimization, scale-up and manufacture of drug substance
  • Ensuring that CMO is managing material handing appropriately and that processes are run safely
  • Providing significant support for process validation projects including criticality assessment, writing/reviewing process validation documentation, and process validation execution.
  • 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 Chemical Development and with personnel from other departments: Analytical Development, Formulation Development, Quality Control, Quality Assurance, Regulatory Affairs, and Project Management

EXPERIENCE AND QUALIFICATIONS:

  • Skills focused on optimization of unit operations such as reactions, distillations, extractions, membrane separations, chromatography, crystallization, centrifugation, filtration, drying and milling.
  • A technical background in kinetics, thermodynamics, fluid mechanics, mass transfer and heat transfer.
  • Experience writing technical reports
  • Analytical skills are desirable, such as HPLC, GC, NMR, microscopy, FTIR, DSC, and/or on-line techniques
  • Team player with ability to positively communicate with team members
  • A basic understanding of government regulation such as FDA cGMPs, ICH guidance EPA hazardous waste regulations, local and federal environmental regulations, and OSHA chemical hygiene plans.
  • Knowledge and understanding of the CMO industry and sources of commercial chemicals
  • Experience with transfer, scale-up and process validation of chemical processes to commercial facilities
  • Hands-on experience with pilot plant scale-up and/or larger scale chemical synthesis desirable
  • Ability to analyze extensive data sets and communicate a summary of their analysis effectively
  • Proficiency with word-processing, spreadsheet, chemical drawing, simulation/modeling, statistical, and project management software (i.e. MS Word, Excel, ChemDraw, Dynochem, Vismix, Aspen, CFD, JMP, Design Expert, MS Project).
  • PhD in Chemical Engineering
  • At least 5+ years in chemical engineering associated with development of pharmaceutical small molecules

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

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96) 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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97) Scientist / Senior Scientist, Analytical Development (Biologics) – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) G111RY

DESCRIPTION:

  • Develop capillary electrophoresis methods for characterizing and release testing of a monoclonal antibody therapeutic. 
  • Develop methods, qualify, and validate methods and transfer methods to QC for QC testing. 
  • Use CE methodologies to characterize micro-heterogeneities in the monoclonal antibody. 
  • Experience with HPLC, mass spectrometry, and other analytical techniques are a plus.
  • Developing and optimizing cIEF and CE-SDS methods
  • Qualification and validation of CE methods and transfer of methods to QC
  • Characterization of micro-heterogeneities by CE methodologies
  • Writing protocols and reports suitable for regulatory submissions

EXPERIENCE AND QUALIFICATIONS:

  • Demonstrated expertise with capillary electrophoresis methodologies (cIEF, CE-SDS, CZE, QIAxcel) is required.
  • Experience and knowledge of method qualification and validation is necessary.
  • Experience with monoclonal antibodies (mAbs) is 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.
  • Strong communication skills, verbal and written, and a team-oriented approach are required.
  • The successful candidate will be organized, self-motivated, and able to work both independently and as part of a team.
  • Excellent writing skills are required.

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

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98) 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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99) 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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100) (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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101) 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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102) 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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103) 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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104) 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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105) 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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106) Director / Sr. Director, Regulatory Affairs – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) G129FS

DESCRIPTION:

Responsible for global regulatory leadership, management and strategic guidance for all regulatory aspects (nonclinical , clinical, CMC) of one to two development stage programs. The responsibilities of this position include defining, implementing and delivering the global regulatory strategy for assigned programs. The individual must possess a thorough knowledge of global rules, regulations, and guidances governing drugs and biologics in all phases of development and be able to provide guidance in interpreting these rules, regulations, and guidelines. Strong leadership, communication (written and verbal), and management skills are required with a hands-on, can-do attitude.

Responsibilities:
 
  • Develop and implement U.S. and ex-U.S. regulatory strategies and act as a regulatory lead to ensure that all activities are conducted in compliance with relevant laws, regulations, and guidance including with manufacturing, research, clinical, and quality assurance.
  • Act as the primary contact for regulatory licensing matters.
  • Review labeling and promotional materials throughout the product lifecycle and communicate labeling changes to all stakeholders.
  • Interact cross-functionally with members of commercial, legal, safety, clinical, manufacturing, quality, medical, and others
  • Plan, coordinate and prepare documents that are submitted to US and international regulatory authorities in support of INDs, BLAs, DMFs CTAs, NDAs and necessary amendments, safety reports, and annual updates.
  • Ensure that regulatory expectations are clear to all internal and external stakeholders (including partners, CROs, consultants and contractors) in order to execute program objectives in compliance with applicable regulations.
  • Represent the Company externally in scientific, financial and business development communities, and in meetings with regulatory agencies serve as a credible, influential, respected corporate spokesperson during all interactions with regulators and regulatory agencies.
  • Ensure regulatory submissions are completed on time by working with project teams to gather the information and documents necessary to file complete and accurate submissions in accordance with corporate goals.
  • Continue positive communications and rigorous interaction with the FDA and other regulatory agencies and ensure activities meet all relevant requirements & guidelines.
  • Identify potential compliance issues and work with respective functions in developing corrective action plans to ensure compliance is achieved.

EXPERIENCE AND QUALIFICATIONS:

  • BS, MSc, or Ph.D. degree in the life sciences with a minimum of 15+ years in drug development in the pharmaceutical/biotechnology industry in the regulatory function.
  • Large Molecule/ biologics experience required
  • Thorough knowledge of global rules, regulations, and guidances governing drugs and biologics in all phases of development.
  • Experience with planning and filing license applications (NDA, BLA, MAA). 
  • Experience with electronic submissions is desired.
  • Must have experience filing a minimum of one license application.
  • Working knowledge of FDA regulations is required as well as experience supporting global clinical studies.  
  • EU experience preferred
  • Experienced self-motivated individual with a record of achievement as a result of past initiatives in submitting successful IND9S) to NDA(s)
  • Regulatory experience in the review of labeling and promotional material.
  • Willingness to handle day-to-day functions while still providing the high-level strategic guidance.
  • Open, available, transparent communicator, able to develop a culture of teamwork and collaboration.
  • Able to develop and maintain excellent working relationships with global health authorities
  • Experience working with project teams and will be well versed in regulatory terminology with the ability to communicate with experienced regulators in the various governmental agencies.
  • Must possess strong leadership, presentation and influence skills.
  • Must possess excellent written and verbal skills (articulate and persuasive).
  • Able to advance group goals to meet company objectives.
  • Able to provide expertise in shaping company direction.
  • Experience at small or start-up company.  
  • Ability to be both strategic and hands on.

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

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107) 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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108) 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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109) Technical Writer – Contract (Pennsylvania) 4062

DESCRIPTION:

  • Technical writing and updating of cGMP documents.  
  • Driving a document through review and approval states, which means dealing with other support groups.
  • Able to complete assigned tasks independently

EXPERIENCE AND QUALIFICATIONS:

  • In depth knowledge of MS Office Programs
  • Microsoft word – high skill level (technical editorial support)
  • TrackWise – Global and North American
  • SAP experience
  • Detail oriented
  • edoc experience preferred
  • Articulate communication skills
  • College degree preferred

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

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110) Associate Director QC Team Lead – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) A131AF

DESCRIPTION:

  • Plans, controls and directs QC testing operations for all product dosage forms. 
  • Oversees/manages facility/equipment utilization relative to compliance of current manufacturing processes/procedures with current Good Manufacturing Practices, health, safety and environmental policies and other federal regulations, and company policies and procedures.
  • Oversight of commercial stability programs, including activities conducted at third parties, to ensure compliance with policies.
  • Plans, organizes and directs the activities of all QC product testing functional areas, to assure that the materials released from the laboratories comply with internal and regulatory requirements, and that agreed upon target dates for work are met.
  • Oversight of third party laboratory operations to ensure compliance with policies.
  • Establishes and maintains proper compliance with cGMPs, as well as corporate/departmental SOPs (cGMP and safety); included are review of procedures to assure complete and accurate testing records, adherence to SOPs, lab failure investigations and reporting procedures.
  • Establishes QC product testing departmental objectives, establishes long-term strategy and resources requirements, and periodically reviews progress toward reaching goals, with ultimate responsibility for meeting those objectives.
  • Approves specifications/control procedures for all products and components; approves operations and QC validation protocols and reports (analytical, cleaning, process computer).
  • Helps create department and corporate quality-related policies and procedures.
  • Establishes and fosters a positive continuous improvement mentality leading to the implementation of best industry practices.
  • Interacts with the FDA, trade associations, and professional groups
  • Represents QA/QC on key cross-functional product and/or process teams and special corporate task forces.
  • Serves on all key quality-related corporate committee including recall, NORMS and GMP.
  • Ensures that all Product Testing associates have the appropriate education, experience and training (cGMP, safety, technical) to effectively, efficiently and safely complete their responsibilities.
  • Assist the Head of Quality to establish operating and capital budgets; manages operating expense budget.
  • Manage deviation and OOS process and assist in resolution.
  • Performs other duties as may be required or necessary.
  • On time delivery of analytical results
  • Laboratory compliance – deviations and audit observations
  • QC Productivity
  • On time completion of stability
  • Customer service level
  • QC compliance with training requirements

EXPERIENCE AND QUALIFICATIONS:

  • Experience with inhalation products; Chemistry background REQUIRED; small molecule experience required
  • Experience leading a GMP commercial lab operation
  • Thorough knowledge of analytical principles, methodologies, and techniques utilized in the pharmaceutical QC environment.  
  • Thorough knowledge of operational functions of production, packaging, technology/MPS, materials management.
  • Thorough understanding of budgeting principles, resource management, and goals/objective setting and implementation.
  • Auditing and technical report writing experience.
  • Expert knowledge and understanding of GMPs, keeping up to date with current industry issues and changing regulations. 
  • Experience in Deviation Management and batch disposition.
  • Experience in Change Control, validation and APR/PQR.
  • Experience with health authorities audits.
  • Proven experience with Lean, 5S, Opex, IQP applied principles
  • Very good user knowledge for Microsoft Word and Excel, SAP and Trackwise.
  • Excellent oral and written communication skills required.
  • Demonstrate leadership ability and excellent interpersonal skills.  
  • Ability to work under minimal direction, independently or as part of a team if necessary.
  • A minimum of 10 years of related pharmaceutical experience.
  • A minimum of 8 years of managerial experience in a QA/QC organization.
  • Bachelors degree in a scientific discipline is required; Advanced degree is preferred.

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

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111) Training Coordinator – Contract (New Jersey) 5114

DESCRIPTION:

  • Load, review and test modules/curriculum in pilot, test and production environments
  • Launch modules and curriculums
  • Set up and run data queries and reports for business/content owners
  • Monitor post-launch feedback and answering help calls regarding access and technical issues, including elearning courses and online assessments
  • Support Instructors in the use of Learn as required (run ad hoc reports, streamline their functionality)
  • Support Reconciliation efforts/coordinate with NA Compliance to ensure compliance as needed
  • iaise with Service Desk on post-launch needs
  • Creation of e-learning from content developed by training content owners as needed
  • Miscellaneous administrative support in the department related to Training and Communications

EXPERIENCE AND QUALIFICATIONS:

  • Solid experience in LMS administration and basic understanding of source system data feeds
  • Strong organizational skills, detail oriented
  • Good oral and written skills
  • Strong Microsoft Office skills
  • Experience in eLearning software such as Articulate & Captivate
  • Storyboarding and instructional design techniques a plus
  • Knowledge of web design/development and layout skills a plus
  • Training delivery experience a plus
  • Bachelors Degree preferred
  • Strong computer skills/advanced training with an emphasis on databases
  • Knowledge of and demonstrated experience with reports software, building queries, etc
  • 3-5 years experience in administrative support position in a training/learning organization
  • 1-2 additional years experience in training preferred
  • Demonstrated experience in developing and managing eLearning technologies

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

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112) Patent Attorney, Director – Full Time (New York) XA130J

DESCRIPTION:

  • The candidate will function as a legal director for dispute resolution
  • Play a key role in the company’s IP enforcement strategies, including managing independently or as part of a team with other law department colleagues pharmaceutical global contentious patent proceedings, including but not limited to pharmaceutical/ biotechnology patent litigation in the US and in Europe. 
  • Manage outside counsel in non-patent litigation as needed; flexibility is required. 
  • Experience with ex parte and/or inter partes reexaminations and ex-US invalidation and opposition proceedings is a plus. 
  • The candidate will report to the Senior Director of Intellectual Property. 
  • Must be willing and able to interact and communicate well with upper management and help develop and advocate for the company’s perspective in global patent enforcement strategies with outside counsel, manage and guide outside counsel effectively, and work with counsel to manage litigation discovery. 
  • Independence and the ability to view litigation from a global perspective with the company’s long-term perspective and critically assess and direct outside counsel are important. 

EXPERIENCE AND QUALIFICATIONS:

  • The position requires excellent analytical, oral communication, and writing skills.
  • The ideal candidate will have 10+ years of legal experience, with at least 3-4 years of law firm experience or experience as a government litigator in patent litigation and at least 2-3 years of in-house experience in pharmaceutical and/or biotechnology litigation. 
  • The ideal candidate will also be able to demonstrate a strong track record of success.
  • An advanced degree in the biological sciences (e.g., genetics or immunology), or its equivalent in experience, is strongly preferred.
  • Admission to the New York bar is preferred. Attorneys not admitted in New York will also be considered under the New York’s in-house counsel registration practice.

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

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113) 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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114) 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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115) 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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116) 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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117) 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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118) Clinical Project Manager – Full Time Position (San Francisco Bay Area) Z82GN

DESCRIPTION:

  • Provide overall coordination and management of a clinical trial, in conjunction with the clinical team, and to serve as the primary contact with the sponsor and clinical team. 
  • Depending on the scope of work, this individual may be involved in some but not all of the functions.
  • Takes a lead role in a study or series of studies, and may provide strategic and tactical planning, organization, direction and tracking for completion of a study or series of studies within a project (including oversight of clinical project timelines, reports, budgets, monitoring, site management, clinical supplies and data collection)
  • Facilitate and foster positive and productive communication between sponsor, team and other functional groups. 
  • Develop and implement a project-specific communication plan, in agreement with the sponsor
  • Ensure timely and accurate communication of all aspects of the project to the team, including sponsor requirements, instructions and changes
  • Communicate with management on project progress, resource needs, sponsor issues, and team member performance
  • With Sponsor input, and based on project requirements, carry out project planning; document plans in writing for distribution to the team, sponsor and management, as appropriate. 
  • Monitor and update plans throughout the life of the project.
  • Quality parameters – identify SOPs, guidelines, templates to be used and provide to members.
  • Develop a plan and obtain sponsor approval before site visits occur;
  • Resource plan – with input from management, and other functional managers, assess how many, who, when and for how long; assess site assignment/workload by region. 
  • Monitor and adjust the resource plan based on project or team member changes
  • Develop contingency plan(s), with team and Sponsor input, for potential hurdles that would delay the project's progress
  • Assess training needs of team members on therapeutic area, protocol, special procedures/skills; develop training plan for new team members added later
  • Develop processes to support the team's activities (i.e. flow of site visit reports and other documents for review and submission, travel calendar, teleconference call-in process, etc.)
  • Identify detailed work activities and develop timelines with team and other functional group input and Sponsor approval (Excel, MSProject tools)
  • Monitor and manage the project's progress, identify hurdles and manage changes, via frequent interactions with team, other functional groups, and sponsor.
  • Schedule regular team meetings/teleconferences to track progress and status of activities and to obtain direction, changes, and decisions
  • Monitor, manage and adjust timelines and milestones with input from team, other functional groups and Sponsor; re-assess critical path and communicate to all
  • Track performance metrics of team
  • Provide informal and formal status reports to Sponsor, team, (and management, as required)
  • Track out-of-scope requests. 
  • Communicate with company and client regarding out-of-scope items
  • Monitor and adjust the resource plan based on project or team member changes
  • Manage study billing/budget versus proposed budget, as appropriate
  • Oversee activities and deliverables of outside vendors, as requested. Ensure communication occurs between outside vendors and others
  • Manage and motivate team members, and monitor and guide their progress.
  • Attend and/or present at Investigator meetings and/or monitor training workshops
  • Develop and/or review study documents (i.e. protocol, investigator brochure, ICF, CRFs, operations manual, study aids, site budget, etc.)
  • Assist members in problem-solving of study and site specific issues
  • Review CRA-generated documents (i.e. site visit reports, letters, telephone reports, as needed)
  • Carry out potential Investigator screening and selection
  • Carry out collection/review of site regulatory documentation

EXPERIENCE AND QUALIFICATIONS:

  • Outstanding interpersonal, oral and written communication skills
  • 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
  • Infectious Disease, phase 3 preferred
  • RN or BS degree in biological sciences or related field or equivalent combination of education and experience: 5+ years CRA experience or 3 years CRA experience and 3 years directly related experience in health care industry.

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

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119) 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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120) 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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121) 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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122) 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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123) 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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124) 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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125) 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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126) 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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127) 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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128) 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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129) 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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130) 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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131) 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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132) 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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133) Professional Discovery Research – Contract (Massachusetts) 2464

DESCRIPTION:

  • Perform in vitro and in vivo assays to contribute towards the discovery and preclinical evaluation of immunotherapeutics and vaccines targeted against diseases   
  • Responsible for performing, documenting and analyzing data generated from experiments designed to characterize immune response elicited to vaccination, characterize antibodies, and study pathogenesis of bacterial targets.
  • Performs ELISA, ELISpot, SDS-PAGE, Western blot, flow cytometry and cell-based assays to evaluate immune response against vaccines and/or characterize antibodies.
  • Use microbiological techniques to evaluate the virulence and pathogenicity of infectious agents.  
  • Maintains and generates bacterial stocks to support preclinical models.
  • Performs in vivo experimental procedures aimed at establishing safety, immunogenicity and efficacy in preclinical models. 
  • Safely handle BSL2 class agents.
  • Document work in lab notebooks and perform laboratory support activities such as maintaining equipment and ordering lab supplies;
  • Summarizes and reports results to the supervisor
  • Perform other duties as assigned.

EXPERIENCE AND QUALIFICATIONS:

  • Hands-on experience in performing ELISA, cell-based assays and microbiological techniques is required.
  • Experience handling small laboratory animals is required.
  • Experience handling BSL2 bacterial agents and culturing anaerobic bacteria is preferred.
  • Excellent attention to detail and reliability are essential.
  • Ability to work as a team member, to follow directions effectively and to manage multiple tasks is required. Once trained on the procedures should be able to exercise judgment and be able to plan, execute experiments and analyze obtained results.
  • Experience with Microsoft Excel, Softmax Pro and GraphPad Prism or other statistical analysis software is a plus.
  • B.S. degree in Biochemistry, Immunology, Microbiology, or related field with minimum two years experience in vaccine or biopharmaceutical industry.

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

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134) SCRA – Contract or Full Time (San Francisco Bay Area) R82BW

DESCRIPTION:

  • Independently lead clinical trial project execution to ensure that trial timelines, costs, and quality metrics are met for a Phase 1 oncology trial
  • Serves as primary contact for functional area representatives in managing the financial aspect of clinical trials to ensure accuracy and timeliness of service provider and site payments.
  • Oversight for forecasting of clinical supplies
  • Manage study milestones to ensure accurate tracking and reporting of study metrics.
  • Manage trial-specific collaborations with other research entities.
  • Oversee ongoing service provider management (e.g., CROs, IVRS, Central Labs), including independent negotiation of scope of work, budgets, performance management, and issue resolution.
  • Create and manage clinical trial budgets and staffing/resourcing plans.
  • Provide study-specific direction and mentoring to CRAs, COCs, and support staff as appropriate. 
  • Manage adherence to ICH/GCP/local regulations.
  • Participate in clinical operations initiatives and programs as assigned and other duties as assigned.
  • Establish and maintain a work environment that fosters learning, respect, open communication, collaboration, integration, and teamwork.
  • Other duties as assigned.

EXPERIENCE AND QUALIFICATIONS:

  • Broad and current knowledge of regulations, clinical development process and therapeutic area to study plans.
  • Proven leadership skills to direct protocol execution to ensure timeline, budget and quality metrics are met.
  • Excellent communication skills to effectively disseminate information within clinical as well as other functional areas as appropriate.
  • Experience developing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management.
  • Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology.
  • Excellent organizational and negotiation skills.  
  • Proven ability in creative problem-solving and possess sound judgment.
  • Team oriented and collaborates effectively with the clinical operations study team, cross-functional team members, and external partners.
  • Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and Outlook.
  • Working knowledge of MSProject for development and update of clinical study timelines.
  • Willing to travel – anticipate 25%.
  • Bachelor’s Degree with 8+ years of clinical research experience.

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

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135) 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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136) 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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137) 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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138) 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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139) 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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140) 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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141) 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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142) 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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143) 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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144) 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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145) 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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146) 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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147) 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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148) 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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149) 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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150) 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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151) Scientist (BS or MS) – Contract (Pennsylvania) 0487

DESCRIPTION:

  • Responsible for authoring documents (protocols, reports, risk assessments) and assembling data packs.   
  • Must have the ability to address and incorporate  comments from team members in a timely fashion.   
  • Must be pro active in scheduling meetings to resolve issues for timely document closure.   
  • Support execution of approved protocols.  
  • The candidate should have sample management experience.
  • Generate Reports in eDoc for three (3) separate cleaning verification protocols
  • Datapacks need to be reviewed and gaps addressed (may require some investigation )
  • Any deviations from the datapacks need to be investigated and closed
  • Reports need to be generated and approved
  • Cleaning validation for kettles
  • There is an identified gap in cleaning validation for some kettles currently in use. The contractor would be asked to address the gap either with a risk assessment report or more likely generation of a cleaning validation protocol
  • Generate a cleaning development protocol to assess a new cleaning agent (execution not required)
  • Cleaning risk assessment for hoses. If assessment determines additional CV required a protocol needs to be generated (execution not required)

EXPERIENCE AND QUALIFICATIONS:

  • Excellent writing and interpersonal skills.
  • Must be well organized and be able to lead meetings and resolve conflict.
  • Excellent communication skill
  • MS Office 2010, LIMS, eDoc, MS Project, Outlook are a must.  
  • BS/BA in Life Sciences, Chemistry, or Engineering

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

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152) 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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153) 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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154) 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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155) 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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156) 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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157) 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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158) 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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159) 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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160) Sr. Director, Clinical Quality Assurance – Full Time Position (San Francisco Bay Area) XR96B

DESCRIPTION:

This hands-on position will lead the Clinical Quality Assurance program.  Will develop and improve the existing GCP-related quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures and protocols. Responsible for developing specific internal procedures, training of staff, and hosting FDA inspections.

Job Responsibilities:
  • Develop GCP-related quality system SOPs in compliance with all applicable regulatory requirements.
  • Ensure clinical trials are performed in accordance with applicable study protocols and are in compliance with all applicable regulatory requirements.
  • Oversee/conduct audits of investigator sites, clinical research organization (CRO) facilities and various clinical vendors.
  • Oversee/conduct audits of clinical study documents, which include investigator brochures, clinical protocols and study reports, case report forms and informed consents forms.
  • Oversee/conduct internal audits to ensure compliance with department guidelines and procedures, and Good Clinical Practice and ICH Guidelines.
  • Provide expert GCP QA advice to Clinical Operations based on analysis and interpretation of updates to GCP regulations to assure best practices.
  • Support the administration of the company’s training program by conducting GCP training to internal departments and externally, if applicable.
  • Manage/conduct targeted training of investigators/site staff.
  • Report GCP deficiencies to QA management.
  • Assist clinical study teams in the development of CAPAs.
  • Coordinate responses to regulatory agency inspections.

EXPERIENCE AND QUALIFICATIONS:

  • Current and strong working knowledge interpretation/implementation of Code of Federal Regulations and ICH Guidelines governing clinical trials and recent initiatives.
  • Excellent verbal and written communication skills, able to lead cross-functional teams and independently, able to 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.
  • Experience working with clinical sites.
  • Experience in developing SOPs in for quality assurance and compliance.
  • Experience with clinical trials at all phases of development.
  • Experience with creating quality systems in a small company environment.
  • BS/BA degree and minimum 10 years of related experience; or MS/MA degree in related discipline and minimum 7 years of related experience.

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

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161) Sr. Director, Clinical Quality Assurance – Full Time Position (San Francisco Bay Area) XR96B

DESCRIPTION:


This hands-on position will lead the Clinical Quality Assurance program.  Will develop and improve the existing GCP-related quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures and protocols. Responsible for developing specific internal procedures, training of staff, and hosting FDA inspections.

Job Responsibilities:
  • Develop GCP-related quality system SOPs in compliance with all applicable regulatory requirements.
  • Ensure clinical trials are performed in accordance with applicable study protocols and are in compliance with all applicable regulatory requirements.
  • Oversee/conduct audits of investigator sites, clinical research organization (CRO) facilities and various clinical vendors.
  • Oversee/conduct audits of clinical study documents, which include investigator brochures, clinical protocols and study reports, case report forms and informed consents forms.
  • Oversee/conduct internal audits to ensure compliance with department guidelines and procedures, and Good Clinical Practice and ICH Guidelines.
  • Provide expert GCP QA advice to Clinical Operations based on analysis and interpretation of updates to GCP regulations to assure best practices.
  • Support the administration of the company’s training program by conducting GCP training to internal departments and externally, if applicable.
  • Manage/conduct targeted training of investigators/site staff.
  • Report GCP deficiencies to QA management.
  • Assist clinical study teams in the development of CAPAs.
  • Coordinate responses to regulatory agency inspections.

EXPERIENCE AND QUALIFICATIONS:

  • Current and strong working knowledge interpretation/implementation of Code of Federal Regulations and ICH Guidelines governing clinical trials and recent initiatives.
  • Excellent verbal and written communication skills, able to lead cross-functional teams and independently, able to 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.
  • Experience working with clinical sites.
  • Experience in developing SOPs in for quality assurance and compliance.
  • Experience with clinical trials at all phases of development.
  • Experience with creating quality systems in a small company environment.
  • BS/BA degree and minimum 10 years of related experience; or MS/MA degree in related discipline and minimum 7 years of related experience.

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

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162) Consulting Ontologist – Contract (San Francisco Bay Area) FR103P

DESCRIPTION:

  • Assist the ontology group in the development of large, high-quality knowledge base of biological concepts with a particular emphasis on the extension of the system to cover new biological concepts.
  • Focus of this position is on chemistry and drug content.
  • Represent and connect biological and chemical concepts
  • May be involved in quality control of modeled concepts

EXPERIENCE AND QUALIFICATIONS:

  • Detail-oriented
  • Strong logic skills
  • Internet savvy
  • Available for training via phone/web conferences; position is off-site
  • Must maintain minimum level of productivity (currently corresponds to at least 10 hrs/week)
  • Must be legally able to accept consulting work in the US
  • Experience with public sources of information about biochemicals, such as PubChem
  • Experience with public sources of information about drugs, such as Drugs@FDA and ClinicalTrials.gov
  • PhD (or Masters with substantial research experience) in biochemistry or organic chemistry
  • No travel required

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

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163) 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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164) 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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165) Clinical Trial Manager – Full Time Position (San Francisco Bay Area) T96NH

DESCRIPTION:

  • Leads activities associated with LOI evaluation and protocol review.  
  • Coordinates the review and communication comments on studies.  
  • In collaboration with the Director, oversees team members, including oversight of vendors.  
  • Coordinates the training of staff involved in programs.  
  • Provides training to Medical Affairs staff and performs performance appraisals of direct reports.
  • Responsible for the review and finalization of project and study-related documents including: protocols, informed consent forms, contracts, budgets, safety reporting, IND Annual updates and review of proposed clinical trial presentations and publications, as required.
  • Responsible for identifying and responding to site and study related issues and recommending corrective actions and/or escalating to Director
  • Coordinate and manage Investigational product supply, including overall accountability and reconciliation
  • Responsible for  the preparation of study budgets and timelines
  • Manage project timelines and correlative studies to meet goals
  • Manage contracts, budgets and payment processes for all vendors including clinical trial sites
  • Monitor and track clinical trial progress and provide status update reports
  • Manage vendors
  • Responsible for selection of staff and coordinating training, including documentation
  • Provide guidance on site issues
  • Lead, with minimal supervision, the planning of meetings and presentations, as required
  • Lead the review of clinical data as needed
  • Represent Medical Affairs on the Review Teams
  • Partner with other research and development groups to achieve deliverables
  • Monitoring of sites for adherence to protocol and GCP as required
  • Travel as required to carry out responsibilities
  • Identify and escalate site, vendor and study related issues to director, as appropriate
  • Participate in clinical and department settings, including attending additional meetings as required, and interact in a positive and professional manner
  • Supervise Clinical Trial Assistants and Clinical Research Associates, and perform performance appraisals
  • Perform other duties as assigned

EXPERIENCE AND QUALIFICATIONS:

  • Must have demonstrated expertise in relevant clinical trial activities
  • Ability to exercise independent judgment within generally defined practices and policies that lead to processes for achieving results
  • Good organization and planning skills
  • Strong interpersonal skills and communication skills (both written and oral)
  • Ability to problem solve and delegate appropriate tasks to subordinates
  • Knowledge of ICH/GCP guidelines and FDA regulations
  • Strong leadership skills, self-motivated, adaptable to a dynamic environment
  • Able to collaborate effectively with study sites, cross-functional team members, and external partners
  • Proficiency in MS Word, Excel and PowerPoint
  • Able and willing to travel approximately 10-20%  
  • 7+ years of relevant clinical experience in a CRO, pharmaceutical, or biotechnology company (including at least 3 years of CRA experience and 2 years of study management experience)
  • Experience in oncology preferred
  • Experience in global trials preferred 
  • BA/BS/MS in a scientific discipline

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

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166) Senior Clinical Research Associate / Clinical Trial Manager – Full Time Position (San Francisco Bay Area) MJ96F

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.
  • 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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167) 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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168) 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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169) 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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170) Associate Director, Clinical Data Management – Full Time Position (San Francisco Bay Area) XT96G

DESCRIPTION:

  • Responsible for the management of the data management group staff and deliverables. 
  • The ideal candidate will build and enforce the appropriate standards in the department for Phase 3 ready. 
  • Responsible for managing CROs and other outside vendors as appropriate. 
  • Act as a liaison between Data Management and Clinical staff.
  • Supervise and provide technical support to the members of the data management department in all activities related to data management.
  • Ensure the data management activities (CRO) adherence to standard and policies that are appropriate and applicable.
  • Direct interaction with functional departments, including Clinical, Regulatory, Safety, and Quality Assurance
  • Ensure data integrity across department following Good Clinical Practices (GCP) and Standard Operating Procedures (SOP)
  • Manage appropriate revision to SOP and policies related to DM and consistent with other department. 
  • Direct supervision all staff in DM department
  • Oversees the work of direct reports to ensure on-time, on-target and within-budget results
  • Provides ongoing coaching, guidance and feedback to ensure direct reports are successful in their work, as well as have the necessary and timely access to information and other resources
  • Conducts regular one-on-one and any other staff meetings to ensure timely communication with direct reports
  • Provides formal performance reviews and career development planning for all direct reports
  • Complies with all company HR policies and procedures, as well as state/federal employment-related laws

EXPERIENCE AND QUALIFICATIONS:

  • Experience working with Oncology trials highly desirable.
  • Phase 3 experience is must, NDA experience is highly desired
  • Strong communication skills, both written and oral
  • 8+ years of Priori management experience in DM
  • Strong computer skills including technical aspects
  • Ability to analyze complex problems/situations requiring in-depth evaluation
  • Ability to use judgment based upon standards and policies to solve problems, meet timelines and provide alternative approaches
  • BS or BA degree in science/computer related field
  • 15+ years clinical data management experience in pharmaceutical/biotech industry, including EDC.

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

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171) 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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172) IT Technical Writer – 6 month contract (San Jose Area) N96GB

DESCRIPTION:

  • Core document areas are ERP implementation, SOX documentation, CRM/Salesforce/Veeva, and General IT controls
  • Types of documents – requirement specifications, design specifications, test strategy, test plans, i.e. IT software development specification documents




      EXPERIENCE AND QUALIFICATIONS:

      • Need deep expertise in the following software:  Word, Excel, Visio, and PowerPoint
      • Previous experience writing and editing IT software development documents
      • Work on site one day a week telecommute is OK.

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

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      173) ERP Finance / IT Analyst – Contract or Full Time Position (San Francisco Bay Area) GN96Q

      DESCRIPTION:

      • Will serve as the technical lead for the ERP Finance module from implementation through ongoing direct support of the Finance group.
      • Should have completed projects utilizing Microsoft Dynamics AX and preferably AX 2012.
      • Will focus on general business processes (AR, AP, GL) as well as 3PL integration, the Sunshine act and data flows from all other resources which will require integration and reporting. These will include but not be limited to CCM / CRM / SFA.
      • This will be accomplished in a compliant manner. 
      • Responsible for custom reporting, system documentation, requirements gathering, end user training, and system testing (unit and integration).

      EXPERIENCE AND QUALIFICATIONS:


      • Demonstrated ability to successfully and simultaneously manage multiple projects with conflicting objectives
      • Excellent verbal and written communication skills
      • Experience with various FP&A tools
      • Ability to facilitate evaluation and compromise among individuals with different perspectives and needs. Must have initiative and the ability to analyze and recommend solutions.
      • Excellent analytical skills, especially at detailed levels, and the ability to organize data into structured plans.
      • A history of professional progress improvement, especially through certification programs or through educational institutions
      • Background in pharma/biotech a plus
      • Prior experience of configuration in association with excellent business logic to guide away from any customization.
      • Demonstrated ability to provide key metrics; make these metrics available and used throughout the corporation. 
      • Working knowledge of Finance and Accounting functions from an operational perspective including tools, processes (Close, Budget cycles, Headcount planning, etc.), & cross-functional interactions.
      • Willingness and flexibility to accommodate needs of finance team through cyclical processes.
      • Collect, analyze, and document business requirements among Finance, Accounting, and Supply Chain functions, and translate these into necessary SOPs to document ERP processes as directed
      • Experience with supporting commercial aspects of Finance ERP implementation (sales, revenue), as well as non-commercial areas of the business.
      • Inventory management including costing of manufacturing by third party manufacturers
      • May assist in an ERP HR module or integration of a stand-alone HR specific application.
      • At least 3-5 years of ERP implementation experience
      • Bachelors degree in IT, Finance or related

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

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      174) 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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      175) 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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      176) General Warehouse Worker – Contract (Pennsylvania) 5225

      DESCRIPTION:

      • Support all warehousing activities including shipping product worldwide
      • Support receiving of Incoming goods
      • Dispensing packaging components to the packaging department
      • Support the annual physical Inventory, 
      • Support the destruction process and any other Inventory management activities.  

      EXPERIENCE AND QUALIFICATIONS:

      • Familiarity with GMP compliance is a plus.
      • Knowledge of Inventory Management software a plus.   
      • Must be detailed oriented, dependable, and able to work independently and also in a team environment.  
      • Looking for a candidate who can pick up tasks quickly and multi-task/prioritize workload in a dynamic, timeline driven, culturally diverse organization.
      • High school diploma or equivalent is required. 
      • Spoken and written English required.

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

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      177) 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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      178) 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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      179) 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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      180) 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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      181) Scientific Marketing Specialist – Contract (Southern California) 73T7776

      DESCRIPTION:

      • Responsible for mapping company SKUs to research workflows.
      • Responsible for updating competitive information, comparing and contrasting product line. 

      EXPERIENCE AND QUALIFICATIONS:

      • Knowledge in any of these area: Cell Culture, DNA (USD) RNA Purification & Analysis, Cloning, PCR, Real-Time PCR, Sequencing, Proteins Expression, Antibodies & Secondary Detection Reagents, Isolation & Analysis, Cell Analysis, RNAi, Gene Expression Analysis & Genotyping.
      • Strong product knowledge in Life Sciences.
      • Proficient in Excel.
      • Excellent organizational/coordination skills and ability to prioritize.
      • Ability to work on a fast-pace environment.
      • Attention to detail.
      • Requires excellent verbal and written communications skills.
      • Minimum of Bachelors Degree in Science of Biology.
      • Must have 2 years research OR 2 years lab experience.

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

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      182) 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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      183) (Senior) Clinical Trial Manager – Full Time (San Francisco Bay Area) R96TW

      DESCRIPTION:

      Leads activities associated with the evaluation, initiation and management of clinical studies to ensure compliance with SOPs, FDA regulations and ICH/GCP guidelines.  Leads study management team, including oversight of CRO and Vendors.  Coordinates the training of staff involved in clinical trial management.  Provides training to clinical operations staff and performs performance appraisals of direct reports.
       

      Key Accountabilities/Core Job Responsibilities:
      • Responsible for  the preparation and finalization of project and study-related documents including: informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, IND Annual Updates and clinical summaries, as required
      • Responsible for  the selection of investigators and study sites
      • Responsible for identifying and responding to site and study related issues and recommending corrective actions and/or escalating to supervisor
      • Coordinate the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IVRS specification process and UAT
      • Ensure that CRF data queries are resolved
      • Coordinate and manage Investigational Product including overall accountability and reconciliation
      • Responsible for  the preparation of study  budgets and timelines
      • Manage project timelines and vendor performance to meet departmental and corporate goals
      • Manage study budget and payment process for all clinical trial vendors including investigative sites
      • Monitor and track clinical trial progress and provide status update reports
      • Manage all clinical trial vendors
      • Responsible for selection of CRO study staff and coordinating training including documentation
      • Hire, train and oversee study Field Monitors (e.g., review of all trip reports) and provide guidance on site issues
      • Lead with minimal supervision in the planning of investigator meetings and making presentations, as required
      • Lead  the review of clinical data at the CRF, data listing, and report table levels
      • Represent Clinical Operations at the Project Team level for individual studies, as appropriate 
      • Partner with other research and development groups to achieve deliverables
      • Participate in Site Initiation Visits (SIVs) as required
      • Co-Monitoring of regional sites for adherence to protocol and GCP as required
      • Travel as required to carry out responsibilities
      • Identify and escalate site, vendor and study related issues to supervisor, as appropriate
      • Participate in clinical and department settings, including attending additional meetings as required, and interact in a positive and professional manner
      • Supervise Clinical Trial Assistants and Clinical Research Associates, and perform performance appraisals
      • Perform other duties as assigned

      EXPERIENCE AND QUALIFICATIONS:

      • Must have demonstrated expertise in relevant clinical operations activities
      • Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results
      • Good organization and planning skills
      • Strong interpersonal skills and communication skills (both written and oral)
      • Ability to problem solve and delegate appropriate tasks to subordinates
      • Knowledge of ICH/GCP guidelines and FDA regulations
      • 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
      • Proficiency in MS Word, Excel and PowerPoint
      • Able and willing to travel approximately 25-30%  
      • 7+ years of relevant clinical experience in a CRO, pharmaceutical, or biotechnology company (including at least 3 years of CRA experience and 2 years of study management experience)
      • Experience in oncology preferred
      • Experience in global trials preferred

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

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      184) 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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      185) 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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      186) CRAII / Senior Clinical Research Associate II (SCRA) – Contract or Full Time Position (San Francisco Bay Area) B80CR

      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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      187) Clinical Program Manager – Full Time Position (San Francisco Bay Area) R80BS

      DESCRIPTION:

      Clinical Program Manager to manage multiple clinical trials.

      • Reports to Director level
      • Manage late stage global clinical study teams, 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
      • Manage CRA to SCRA level clinical operations personnel

      EXPERIENCE AND QUALIFICATIONS:

      • Bachelor’s degree in a relevant scientific discipline or equivalent
      • At least 7 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
      • 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 a large Phase 2B trial
      • Study start-up experience is highly desirable
      • Global (Asia, Europe, South America, Middle East, or Africa) 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.
      • Basic relocation provided

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

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      188) Biotechl Recruiter / Sourcing Specialist – (Full Time or Part-time, San Francisco Bay area preferred)

      DESCRIPTION:

      We have openings for several recruiters and are therefore flexible in terms of full or part time.

      • Primary responsibilities are to source open positions with qualified candidates
      • Document/track recruiting activities in candidate tracking system.
      • Source, screen and interview candidates
      • Prepare candidate summary for submission to the Account Manager
      • May also act as Account Manager depending on experience or recruiter
      • Other work as assigned (e.g. attend networking meetings, do job postings etc.)

      EXPERIENCE AND QUALIFICATIONS:

      • Must have minimum of 4 years of solid recruiting experience.
      • Experience must be with Pharma, diagnostics or medical devices companies.
      • Prior experience and absolute comfort with making cold calls
      • Must be self-motivated, present well and be able to develop relationships with candidates.
      • Should feel comfortable representing the company at networking meetings
      • Ability to navigate through change and demonstrate flexibility as organizational needs shift.
      • Excellent organizational skills and the ability to work independently is very important
      • Must develop and implement creative sourcing strategies to identify talent in addition to utilizing company sourcing tools
      • Bachelor degree required
      • Must live in the United States and have U.S. work status;  Residence in California especially the San Francisco Bay area preferred

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

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      189) Clinical Laboratory Scientists (CLS)/Research Associate (RA) – Full Time Position (San Francisco Bay Area) BD64G

      DESCRIPTION:

      Responsible for performing high complexity laboratory testing on patient specimens, interpreting and reporting patient results, performing quality control and quality assurance procedures and complying with all applicable local, state and federal laboratory requirements. The high complexity nature of the work requires excellent attention to detail, effective written and verbal communication skills, the ability to multitask and be flexible with tasks and schedules and the ability to work independently in a team environment.

      Principal responsibilities include:

      • Perform laboratory tests, procedures and analyses according to the laboratory’s standard operating procedures.
      • Perform, review and document laboratory quality control procedures.
      • Operate, maintain and troubleshoot laboratory equipment.
      • Prepare reagents required for laboratory testing.
      • Review, interpret and report patient results.
      • Independently identify and troubleshoot basic problems that adversely affect test performance.
      • Report all concerns of test quality and/or safety to the Supervisor or Safety Officer
      • Assist with final development of protocol and processes for a Laboratory Developed Test and perform other duties as assigned.

      EXPERIENCE AND QUALIFICATIONS:

      • Proven successful track record and comfortable with a start-up environment.
      • Must possess a valid California CLS license, generalist preferred.
      • Completion of a CLS training program at an accredited institution or clinical laboratory work experience within the last five years.
      • Possess working knowledge of local, state and federal laboratory regulations.
      • Computer skills a must, automation skills preferred.
      • Ability to analyze and problem solve basic issues that impact test performance.
      • Strong communicator with ability to maintain open communication with internal employees, managers and customers as needed.
      • Must communicate effectively with coworkers and non-laboratory personnel
      • Able to integrate and apply feedback in a professional manner.
      • Able to manage daily test processing needs with high emphasis on quality.
      • Ability to work as part of a team.
      • Ability to perform repetitive tasks.
      • High volume laboratory experience preferred.
      • Training in molecular biology techniques preferred.

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

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      190) 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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      191) Packaging Technician – Contract (Pennsylvania) 3156

      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 and dependable. 
      • Prefer experience in the clinical packaging: however willing to train.
      • Able to work independently and 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 or equivalent is required.

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

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      192) R&D Software Developer Medical Technology – Full Time or Contract Position (San Francisco Bay Area) L74HT

      DESCRIPTION:

      • Design, develop and prototype pattern recognition, data collection and data processing algorithms
      • Use various software tools for processing and visualization of the experimental data
      • Work closely with interdisciplinary development team on acquisition and processing high quality data
      • Participate in digital signal processing algorithm development
      • Write documentation and white papers on algorithms, data processing and data presentation
      • Participate in definition of features, functionality and other software requirements

      EXPERIENCE AND QUALIFICATIONS:

      • Excellent written and oral communication skills
      • Experience in object oriented design and development
      • Knowledge of Linux and Windows operating systems
      • Experience in Qt and/or .NET frameworks
      • Familiarity with source code control tools preferably Mercurial (Hg)
      • Experience in grant proposal writing
      • MS/PhD in Computer Science, Math or Physics
      • Strong knowledge of pattern recognition and signal processing algorithms
      • Strong knowledge of statistics and data processing
      • Experience in MATLAB and Scilab
      • Experience in software development using C++ or other object-oriented language
      • Experience in data presentation and visualization

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

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      193) Clinical Laboratory Scientists (CLS)/Research Associate (RA) – Full Time Position (San Francisco Bay Area) BD64G

      DESCRIPTION:

      Responsible for performing high complexity laboratory testing on patient specimens, interpreting and reporting patient results, performing quality control and quality assurance procedures and complying with all applicable local, state and federal laboratory requirements. The high complexity nature of the work requires excellent attention to detail, effective written and verbal communication skills, the ability to multitask and be flexible with tasks and schedules and the ability to work independently in a team environment.

      Principal responsibilities include:

      • Perform laboratory tests, procedures and analyses according to the laboratory’s standard operating procedures.
      • Perform, review and document laboratory quality control procedures.
      • Operate, maintain and troubleshoot laboratory equipment.
      • Prepare reagents required for laboratory testing.
      • Review, interpret and report patient results.
      • Independently identify and troubleshoot basic problems that adversely affect test performance.
      • Report all concerns of test quality and/or safety to the Supervisor or Safety Officer
      • Assist with final development of protocol and processes for a Laboratory Developed Test and perform other duties as assigned.

      EXPERIENCE AND QUALIFICATIONS:

      • Proven successful track record and comfortable with a start-up environment.
      • Must possess a valid California CLS license, generalist preferred.
      • Completion of a CLS training program at an accredited institution or clinical laboratory work experience within the last five years.
      • Possess working knowledge of local, state and federal laboratory regulations.
      • Computer skills a must, automation skills preferred.
      • Ability to analyze and problem solve basic issues that impact test performance.
      • Strong communicator with ability to maintain open communication with internal employees, managers and customers as needed.
      • Must communicate effectively with coworkers and non-laboratory personnel
      • Able to integrate and apply feedback in a professional manner.
      • Able to manage daily test processing needs with high emphasis on quality.
      • Ability to work as part of a team.
      • Ability to perform repetitive tasks.
      • High volume laboratory experience preferred.
      • Training in molecular biology techniques preferred.

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

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      194) Senior/Associate Director Program Manager – Full Time or Contract (San Francisco Bay Area) P73BY

      DESCRIPTION:

      The Program Manager for the Molecular Diagnostics (MDx) Business Unit manages the development of internally developed diagnostics products or companion diagnostics products co-developed with external partners. This responsibility requires involving departmental or cross-functional teams focused on the delivery of new products. Plans and directs schedules and may monitor budget/spending. Monitors the project from initiation through delivery. Organizes the interdepartmental activities ensuring completion of the project/product on schedule and within budget constraints. Has overall project management responsibility. In this role, direct people management responsibility is not required.

      Essential Functions:

      • Leads cross functional core team through product launch
      • Develops project plan and timeline
      • Coordinates with external Assay Partner teams to achieve project / product deliverables
      • Be the internal expert in PCP process and IVD project management.
      • Act as “mini GM” as leader of cross functional core team.
      • Act as communication liaison with Business Unit Management to assure deliverables are met, appropriate resources are applied and team(s) remains focused and engaged

      Competencies:

      • Facilitative leadership skills, particularly the ability to influence stakeholders in other functions over whom the Project Manager has no direct authority. Must be a highly-motivated driver able to complete tasks by leveraging relationships and established goals.
      • Has analytical skills, especially the ability to generate alternative solutions and manage risk by identifying criteria for trade-off decisions and helping to facilitate difficult conversations.
      • Willingness to be flexible and adaptable in a complex, matrixed environment. The ability to adapt to changing needs and parameters caused by time, budget, or other constraints
      • Discusses and presents factual information to other members of the team. Ability to convey very complex information in both written and oral form. Actively and constructively contributes to core team’s efforts through networking within the organization and effectively communicating to MDx management. Able to influence others and gain acceptance and build consensus.
      • Ability to manage moderately complex projects and initiatives.
      • Acts as a mentor/role model for team members.
      • Demonstrates understanding of company’s external customer needs and how they affect business unit products and services.
      • Makes decisions that involve the consideration of complex issues.
      • Works autonomously and checks-in as decisions are made.

      EXPERIENCE AND QUALIFICATIONS:

      • The candidate will have 3-5 years of project management experience in IVD product development
      • Experience with Device Design Control and biological/PCR based diagnostics is strongly desired
      • Working knowledge of design control and FDA QSR requirements
      • Microsoft Project Management skills
      • The candidate will have proven ability to execute through influence within a matrixed organization
      • The candidate will have an undergraduate degree in science or engineering. Additional advanced degrees are preferred but not required
      • In their repertoire, the candidate will be self-motivated & a driving force of execution in their current or past organizations
      • Experience working with external collaborators; Negotiations skills; Leading through influence
      • Strong written and verbal communication skills
      • Strong presentation skills
      • PMP certification is preferred

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

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      195) R&D Software Developer Medical Technology – Full Time or Contract Position (San Francisco Bay Area) L74HT

      DESCRIPTION:

      • Design, develop and prototype pattern recognition, data collection and data processing algorithms
      • Use various software tools for processing and visualization of the experimental data
      • Work closely with interdisciplinary development team on acquisition and processing high quality data
      • Participate in digital signal processing algorithm development
      • Write documentation and white papers on algorithms, data processing and data presentation
      • Participate in definition of features, functionality and other software requirements

      EXPERIENCE AND QUALIFICATIONS:

      • Excellent written and oral communication skills
      • Experience in object oriented design and development
      • Knowledge of Linux and Windows operating systems
      • Experience in Qt and/or .NET frameworks
      • Familiarity with source code control tools preferably Mercurial (Hg)
      • Experience in grant proposal writing
      • MS/PhD in Computer Science, Math or Physics
      • Strong knowledge of pattern recognition and signal processing algorithms
      • Strong knowledge of statistics and data processing
      • Experience in MATLAB and Scilab
      • Experience in software development using C++ or other object-oriented language
      • Experience in data presentation and visualization

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

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      196) Paralegal/Contracts Associate – Part Time Position 20 Hrs/week (San Francisco Bay Area) YR90W

      DESCRIPTION:

      Will work under the direction of the Contracts Manager and will be primarily responsible for all contract management duties within the department. Responsible for preparing and executing signature of contracts including, confidential disclosure agreements, consulting agreements, master service agreements, SOW, and other contract types. Shall provide professional legal support; drafting, reviewing and negotiating standard form contracts. Will manage the contract lifecycle for all corporate contracts, organize and maintain contracts database, provide contract review, interpretation of contract terms, and provide contract status updates and tracking.

      • Personal commitment to the company mission and vision.
      • Ability to identify problems and creatively solve them.
      • Superior communication skills both written and verbal.
      • Exceptional organizational and negotiation skills and attention to details.
      • Capable of prioritizing, handling multiple projects simultaneously and the ability to meet strict timelines.
      • Ability to maintain a positive attitude in a fast pace environment.
      • Willingness to share knowledge and train.
      • Demonstrate flexibility and ability to work independently and in a team/collaborative environment.
      • Interpret, draft and negotiate standard form contracts.
      • Guide other business function/department members on company contracts process as required.
      • Work with and support maintenance of the Legal Department’s contract request and database systems.
      • Maintain the workflow, prioritize, and complete multiple concurrent tasks in the face of constantly changing and competing priorities.
      • Provide and/or coordinate advice to internal clients on contract matters.
      • Ensure business activities and contracts comply with internal policies and guidelines, and industry laws and regulations.
      • Manage patent and trademark portfolio and coordinate with outside counsel as needed.
      • Manage the contracts database.
      • Monitor and track the status of contracts to ensure completion.
      • Know when to escalate to executive management any conflicts arising from contracts.
      • Train internal teams on contract forms and procedures.

      EXPERIENCE AND QUALIFICATIONS:

      • A bachelor’s degree or paralegal certificate is preferred with three (3) to six (6) years of relevant experience required.
      • Experience with drafting and negotiating contracts in a pharmaceutical or biotech industry, highly preferred.
      • Thorough understanding of the contract process including contract evaluation, negotiation, approval, tracking and close-out.
      • Experience with or knowledge of intellectual property and data privacy contract issues, highly preferred.
      • Experience with or knowledge of Pharma contract issues that overlap with FDA/pharmaceutical regulation is desirable, but not required.
      • The ideal candidate will be flexible and willing to learn new procedures and skill sets.
      • Strong computer literacy (Word, Excel and contract databases knowledge).

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

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      197) Manager, Sr. Manager, Regulatory Affairs CMC – Contract or Full Time Position (San Francisco Bay Area) Q77AB

      DESCRIPTION:

      Expertise with biologics and/or small molecule experience is essential. Manage CMC aspects of domestic and international regulatory affairs for multiple commercial and clinical projects. Responsible for obtaining and interpreting global CMC regulations and guidance and providing regulatory advice to Quality and Manufacturing team members.

      Work closely with CMC teams, corporate partners, and contract manufacturing organizations to prepare complete and accurate CMC submissions and meet established timelines. Responsible for interaction with global Regulatory authorities to ensure acceptance, rapid review, and approval of marketing applications, supplements, Variations, clinical trial applications, and other filings which present CMC information. Demonstrated strong communication and submission/ personnel management skills are required.

      • Plan, manage, and oversee preparation, and submission of global CMC submissions, including marketing and clinical trial applications.
      • Ensure that CMC content is complete, well-written, and meets all relevant requirements. Assess proposed manufacturing changes for global impact, and provide strategic regulatory guidance for optimal implementation of changes.
      • Provide regulatory advice to technical operations departments based on knowledge of current requirements.
      • Manage interactions with FDA or other regulatory authorities for assigned projects.
      • Develop excellent relationships with internal functional groups, contract manufacturing organizations, and corporate partners.
      • May supervise one or more Associates.

      EXPERIENCE AND QUALIFICATIONS:

      • BA/BS degree in life sciences is required; advanced degree is a plus.
      • Required:
        • At least 5 years of experience in Regulatory Affairs or related discipline in the pharmaceutical or biotechnology industry (preferably with exposure to both development and commercial phases of product lifecycle).
        • Experience in management and filing of marketing applications, supplements, and/or Variations for pharmaceutical or biologic products in the U.S. and/or Europe.
        • Experience in assessing post-marketing changes is critical.
        • Proven ability to lead cross functional CMC teams on projects and sub-teams.
        • Thorough understanding of relevant CMC drug development regulations and guidelines.
        • Outstanding interpersonal and communication (written and verbal) skills.
        • Proficiency with standard software programs (e.g., Word).
      • Preferred:
        • Proven ability to successfully interact with Regulatory Authorities.
        • eCTD experience is desirable.
        • Demonstration of effective skills in managing regulatory professionals.
        • Strong background in chemistry, molecular biology, or similar is desirable.

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

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      198) (Senior) Reliability Engineer Manufacturing & Production/ Industrial Manufacturing – Full Time Position (San Francisco Bay Area) S62BA

      DESCRIPTION:

      The Reliability Engineer II/Senior Reliability supports individual contributor activities in the areas of Reliability and Maintenance Engineering. The position reports to the Senior Manager of Process

      Engineering in the Technology Department. The Reliability Engineering group’s mission is to maximize equipment availability through the deployment of Reliability Engineering best practices in equipment design, assessment of operating equipment health, and structured root cause analysis of failed equipment in order to enable the site to meet the needs of patients through sustained equipment reliability.

      Responsibilities:

      Development and implementation of the overall site Reliability strategy and program, and support the incorporation of this into the site Integrated Risk Management program. Development, execution, analysis and optimization of:

      • predictive and condition based maintenance and monitoring programs, including lubrication, vibration, thermography, motor circuit analysis, eddy current, ultrasound, and corrosion trending.
      • reliability-centered maintenance, design and spares programs to ensure reliable asset operations and an optimized maintenance cost structure.
      • asset lifecycle strategies to support reliable operations and integration of asset retirement into site business planning processes.

      Execute Maintenance Engineering activities:

      • Determination of component/equipment repair, replacement, and retirement strategies.
      • Development, review and approval of repair procedures.
      • Technical reviews for spare parts requirements and obsolete component replacements.
      • Development and review of maintenance procedures and practices.
      • Review and revision of engineering specifications.
      • Audits of maintenance-related suppliers.

      Other duties:

      • Complete analysis and reporting of equipment performance metrics, and identification and prioritization of asset improvements.
      • Execute failure and root cause analyses to identify failure modes and causes to provide technical assessments.
      • Develop and implement recommendations to mitigate identified reliability risks.
      • Develop and deliver reliability and maintenance training to site maintenance, operations, and technical personnel.
      • Identify, develop, and implement industry and company network best practices into the Reliability and Maintenance Engineering programs.

      EXPERIENCE AND QUALIFICATIONS:

      • Bachelors of Science in Mechanical, Chemical or Electrical Engineering with a minimum of 8 years of experience in a Reliability and Maintenance Engineering role.
      • Advanced engineering degree and/or certification in maintenance and reliability, experience with SAP Plant Maintenance module, and cGMP knowledge is desirable.
      • Demonstrate strong proficiency in Reliability Engineering principles and techniques, and the successful application/implementation of this knowledge.
      • Demonstrate effective communication and interpersonal skills with technical and non-technical personnel, including Operations, Maintenance, Technology, Quality and Senior Management.
      • Work collaboratively across departments and lead cross-functional teams in the development, implementation, and sustainment of an overall Site Reliability Program.
      • Experience in industrial or pharmaceutical manufacturing facilities, knowledge in the use of computerized maintenance management systems, and Level 2 certification in lubrication, vibration, thermography and motor circuit analysis is preferred.
      • 7+ to 10 years of relevant experience.
      • No management experience required.
      • Willingness to travel – occasionally.

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

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      199) EBM Biostatistician - Senior – Contract (New Jersey) 5863

      DESCRIPTION:

      The EBM biostatistician provides statistical expertise for all observational research project sponsored by Evidence Based Medicine (EBM) in protocol development, Statistical Analysis Plan (SAP) preparation and study report. The role needs to ensure that appropriateness of study design, sample size and statistical methodologies are used and adherence to the established standards and SOPs. The role manages the timely execution of statistical and research methodological components of EBM study protocols in order to meet project objectives and has a thorough understanding of current requirements for statistical standards.

      Roles/Responsibilities

      • Utilize statistical knowledge of and expertise to provide statistical support for EBM studies, with a main focus of real-world observational studies, database examples: 1)US medical and pharmacy claims databases (e.g. MarketScan); 2) US medical record databases (e.g. GE Healthcare); 3) US government public use databases (e.g. NHANES, MEPS).
      • Participate in study concept, protocol and SAP development and ensure appropriateness of study design, sample size and statistical methodologies proposed.
      • Specify the structure of the datasets that will be delivered for statistical analysis to ensure that the structure follows any existing company standard for databases pooling.
      • Mock-up, review, and approve tables, listings and graphs specifications.
      • Actively participate in project/study team meetings.
      • Establish/negotiate timelines for completion of study-related statistical activities. Ensure the study timelines are met.
      • Conduct observational data analysis, include data management, statistical programming, interpretation of analyses results, and write-up/review the corresponding sections of EBM study report.
      • Produce analysis datasets, listings, tables, and figures for research projects, according to specifications, while maintaining documentation and complying with pre-defined project / study standards.
      • Provide oversight of the biostatistics-related activities for EBM studies subcontracted to a CRO.
      • Oversee the CROs work on the preparation of analysis plans, development and validation of computer algorithms for inferential analyses, statistical writing of study reports, and other outsourced analyses as appropriate.
      • Perform quality control procedures to ensure that statistical deliverables conform to the requirements outlined in the SAP.

      EXPERIENCE AND QUALIFICATIONS:

      • Working knowledge and experience with bio statistical analysis and SAS programming.
      • Excellent oral and written communication skills in English are a must.
      • Prior work experience in epidemiology, health economic and outcome research, or clinical research area is a plus.
      • Specific experience and understanding of outcomes research, drug development is an asset
      • Familiarity with observational databases desirable; US medical and pharmacy claims databases (e.g. MarketScan), US medical record databases (e.g. GE Healthcare), US government public use databases (e.g. NHANES, MEPS)
      • Ph.D. in Statistics highly preferred
      • Minimum 5-year experience in pharmaceutical research or equivalent

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

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      200) Senior Statistical Analyst/ Manager, Statistical Programming – Full Time Position (San Francisco Bay Area) JM96B

      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.

      • 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.
      • 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.
      • Works closely with biostatistics to create analysis files specifications following the instructions provided in Statistical Analysis Plan (SAP).
      • Create/acquire tools to improve programming efficiency or quality.
      • 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.
      • Solid knowledge of CDISC standard (SDTM & ADaM).
      • Minimum 9 years Pharmaceutical/Biotech programming experience.
      • Experience working with Oncology trials required.
      • 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/MS in Statistics, Math or Scientific Discipline.

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

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      201) Associate Director/ Principal, Biostatistics – Full Time Position (San Francisco Bay Area) F96MP

      DESCRIPTION:


      DESCRIPTION:

      Responsible for designing, planning and conduct of clinical studies for a development molecule candidate. Contributes to technical and managerial leadership and organizational improvement. Responsible for providing leadership within the biostatistics department and making recommendations with regards to the strategic aspects of clinical studies as well as oversight of biostatistics activities.

      • Ensures that proper activities are undertaken for the timely and quality to meet corporate objectives.
      • Collaborates interdepartmental and scientific activities, especially collaboration with medical monitors on protocol design (author or supervisor statistical methods section and generate study randomization). 
      • Generate statistical analysis plan for assigned protocols (including mock displays).
      • Assume responsibility for individual studies, write statistical portion of integrated clinical/ statistical reports.
      • Develop statistical programs as necessary 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 to ensure that protocol objectives are met and project standards are maintained.
      • Responsible for ensuring compliance with departmental and company goals.
      • Effectively communicates timely and relevant updates to all team members involved.
      • Expected to lead projects or direct reports, and is responsible for ensuring and overseeing the work of others including mentoring of staff on all assigned clinical studies.


      EXPERIENCE AND QUALIFICATIONS:

      • Demonstrated sound knowledge of applied statistics and biostatistics and relevant experience in the application of statistics to medical trials.
      • Applies judgment and professional expertise independently.
      • Able to prioritize and handle multiple tasks simultaneously.
      • Prior management/supervisory experience (for Associate Director title).
      • 15 years related experience in clinical development in a pharmaceutical company. 
      • 2-5 years supervisory experience.
      • Previous experience with all phases of clinical research.
      • Previous experience in successful NDA.
      • Leadership in resource allocation, budget forecasting, project planning and implementation.
      • PhD in Biostatistics preferred.

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

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      202) Administrative Assistant – Executive – Contract (New Jersey) 0203

      DESCRIPTION:

      • Manages multiple, sometimes conflicting, priorities in a fast-paced and demanding environment.
      • 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. 
      • Prioritizes and executes tasks with minimal direction or supervision. Handles confidential information.  Compiles and prepares information for presentations using MS Office software, including but not limited to, correspondence, reports, tables & analyses.
      • Provides a positive presence and excellent support with answering and prioritizing telephone calls, responding to email and mail communications, and meeting in person.  Contacts involve planning and preparation of the communications, require skill, tact, persuasion and/or negotiation to accomplish the objectives of the communication
      • Interfaces with staff and senior level managers, internal/external customers and vendors. Ensures smooth and efficient flow of day-to-day operations.
      • Takes initiative and independently manages special/administrative projects in dynamic fast paced environment.
      • Perform other duties as assigned

      EXPERIENCE AND QUALIFICATIONS:

      • Ability to work independently and proficiently in a global, multi-site, multi-national environment.
      • Demonstrated ability to work effectively and cooperatively in a team environment. Establishes and maintains good working relationships and internal networks with minimal direction.  Strong interpersonal skills.
      • Proficiency demonstrated in Microsoft Office software/tools.
      • Ability to manage complex meeting arrangements and travel plans/arrangements.
      • Ability to multi-task, exercise judgment, make decisions, and take action to complete assignments in a fast-paced, changing work environment
      • Excellent verbal and written communication skills.
      • High ethical standards, maintenance of confidentiality
      • High school diploma
      • 5-7 years in comparable administrative position supporting an executive (s)
      • Minimum 2 years experience with a pharmaceutical firm

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

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