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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) Director, International Regulatory Affairs – Full Time (San Francisco or Greater Bay Area) X113FP

2) Analytic Biochemist – Contract (San Francisco Bay Area) 6924A73

3) Associate Product Manager – Contract (San Francisco Bay Area) 73B6198

4) Clinical Trial Manager / Sr. CTM - Oncology – Contract (San Francisco or Greater Bay Area) G82KZ

5) Clinical Trial Assistant – Full Time (San Francisco or Greater Bay Area) AP82R

6) Training Analyst – Contract (New Jersey) 0813

7) Quality Engineer III – Full Time (Maryland) RL73G

8) Quality Engineer III – Full Time (Maryland) RL73G

9) Analytical Research Associate – Contract (San Francisco or Greater Bay Area) J129FM

10) Manager, Regulatory Affairs – Full Time (San Francisco or Greater Bay Area) BZ129H

11) Associate Director Clinical Operations – Full Time (San Francisco or Greater Bay Area) RA140Y

12) Sr. Manager / Associate Director/Director, CMC Project Management – Full Time (San Francisco or Greater Bay Area) A82FY

13) Project Coordinator II – Contract (New Jersey) 0250

14) Sr. Manager / Associate Director/Director, CMC Project Management – Full Time (San Francisco or Greater Bay Area) A82FY

15) Project Manager III – Contract (New Jersey) 4155

16) CMC Project Manager (Sr. Manager / Associate Director Level) – Full Time (San Francisco or Greater Bay Area) MB157J

17) CDM Systems Project Manager – Contract Position (San Francisco or Greater Bay Area) RP156B

18) Marketing Assistant – Contract (Southern California) 8266G73

19) Project Coordinator II – Contract (New Jersey) 7352

20) Manufacturing Leader – Full Time (New York Area) NH73K

21) Senior Medical Director / Medical Director, Clinical Development – Full Time (San Francisco or Greater Bay Area) YS139B

22) Vice President, Regulatory Affairs – Full Time (San Francisco or Greater Bay Area) B139KZ

23) Project Manager – Full Time (San Francisco or Greater Bay Area) DY113R

24) Clinical Project Manager – Full Time (San Francisco or Greater Bay Area) XP127J

25) Research Assistant – Contract (San Francisco or Greater Bay Area) A127HM

26) Administrative Assistant I – Contract (New Jersey) 5155

27) SAS Programmer – Contract (New Jersey) 5029

28) Administrative Assistant III – Contract (Massachusetts) 2375

29) (Senior) Manager, Regulatory Operations – Full Time (San Francisco or Greater Bay Area) JN113W

30) CDM Systems Project Manager – Contract Position (San Francisco or Greater Bay Area) RP156B

31) Director QA, GxP Quality Systems – Full Time (San Francisco or Greater Bay Area) F110JV

32) Administrative Assistant 1 – Contract (New Jersey) 4183

33) Histology Technician – Contract (Massachusetts) 2344

34) Process Development Scientist – Full Time (San Francisco or Greater Bay Area) EG146H

35) Medical Director – Full Time (San Francisco or Greater Bay Area) TG155B

36) Executive Human Resources Coordinator – Full Time (San Francisco Bay Area)

37) Senior Manager (Clinical), Regulatory Affairs – Full Time (San Francisco or Greater Bay Area) FJ113N

38) Senior Clinical Research Associate – Full Time (San Francisco or Greater Bay Area) W82LM

39) Senior Clinical Document Assistant – Full Time (San Francisco or Greater Bay Area) FH82P

40) Head of Clinical Operations – Full Time or Consultant (San Diego Area) YF154W

41) (Senior / Associate) Director, Regulatory Affairs – Full Time (San Francisco or Greater Bay Area) J151DP

42) Director, Clinical Operations – Full Time (San Francisco or Greater Bay Area) B151GQ

43) Sr Programmer / Principal Dataset Statistical Programmer – Full Time (Boston Area) GP153F

44) Medical Director Gastroenterology – Full Time (San Francisco or Greater Bay Area) FQ140K

45) Director Project Manager – Contract (10 to 15 hrs/wk long term) (San Francisco or Greater Bay Area) GB152Y

46) Director, Regulatory Affairs – Full Time (San Francisco or Greater Bay Area) BG111P

47) Sr. Product Development Test Engineer – Full Time (San Francisco or Greater Bay Area) F122KM

48) Executive Director, Clinical Regulatory Affairs – Full Time (San Francisco or Greater Bay Area) AP113X

49) CTM / Sr. Clinical Trial Manager - Oncology – Full Time (San Francisco or Greater Bay Area) JM82P

50) Manufacturing Test Engineer, Systems Engineering – Full Time (San Francisco or Greater Bay Area) LM73V

51) Clinical Program Manager – Full Time or Contract to Full Time (San Francisco or Greater Bay Area) G121PA

52) Project Team Leader/ Sr Director – Full Time (San Francisco or Greater Bay Area) RY151F

53) Clinical Trial Manager – Full Time (San Francisco or Greater Bay Area) GA139X

54) Engineer II, Mechanical – Full Time (San Francisco or Greater Bay Area) G73AX

55) Staff Engineer, Mechanical – Full Time (San Francisco or Greater Bay Area) LZ73H

56) Associate Director / Director of Quality Assurance – Full Time or Consultant (San Francisco or Greater Bay Area) P150WB

57) Test Engineer III – Full Time (San Francisco or Greater Bay Area) KW73B

58) Senior Director – Project Team Leader – Full Time (San Francisco or Greater Bay Area) A139JX

59) Clinical Program Manager – Full Time (San Francisco or Greater Bay Area) G149PR

60) Statistical Programmer Manager / Associate Director – Full Time (San Francisco or Greater Bay Area) MG140P

61) Manager, Regulatory Affairs – Full Time (San Francisco or Greater Bay Area) WB148M

62) Associate Director, Clinical Operations – Full Time (San Francisco or Greater Bay Area) Z148PG

63) Regional Pharmaceutical Sales Representative – Full Time (San Francisco, Boston, Wash D.C., Philadelphia, Raleigh/Durham) YA147T

64) Manager / Sr. Manager, Regulatory Affairs – Full Time (San Francisco or Greater Bay Area) AG132D

65) Senior HFM Analyst – Contract (Southern California)

66) R & D Scientist (Senior Scientist) – Full Time (San Francisco or Greater Bay Area) W146KQ

67) Director of Technology Transfer – Full Time (San Francisco or Greater Bay Area) YP146B

68) Regional CRA – Full Time (Western US) DM104Z

69) Regional CRA – Full Time (Central US) G104ZA

70) Regional CRA – Full Time (Northeastern US) BY104K

71) Senior Global Project Manager – Full Time (San Francisco or Greater Bay Area) B100FQ

72) Manufacturing Technician – Contract (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) T145JA

73) Cost Analysis 1 – Contract (Massachusetts) 8205

74) Biostatistics Sr Manager / Associate Director/ Director – Full Time (San Francisco or Greater Bay Area) J140FB

75) Manufacturing Associate 1 – Contract (Massachusetts) 6644

76) Manufacturing Specialist III – Contract (Massachusetts) 9544

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

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

79) Associate Director, Clinical Regulatory – Full Time (San Francisco or Greater Bay Area) A113KZ

80) (Senior) CMC Project Manager – Full Time (San Francisco or Greater Bay Area) YP127G

81) Publication Planning Lead (Associate Director Medical Communications) – Full Time (San Francisco or Greater Bay Area) A132FJ

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

83) Associate Director/ Director CMC – Full Time (San Francisco or Greater Bay Area) GT113F

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

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

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

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

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

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

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

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

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

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

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

95) Clinical Trial Manager – Full Time (San Francisco or Greater Bay Area) A129DK

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

97) Engineering Technician – Contract (San Francisco Bay Area) 73H9179

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

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

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

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

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

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

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

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

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

107) Biotech Recruiter / Sourcing Specialist – Full Time or Part Time (San Francisco Bay Area)

108) Associate Director / Sr. Manager Clinical Supply Chain – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) JQ111V

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

110) Clinical Research Associate/ SCRA, Clinical Trial Manager – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) B127HY

111) Clinical Research Associate / Senior Clinical Research Associate – Full Time (San Francisco or Greater Bay Area) D129LT

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

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

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

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

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

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

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

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

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

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

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

123) Manager / Sr. Manager, Regulatory Affairs – Full Time (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) PN94G

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

146) Sr Human Resources Coordinator/ Associate / Manager – Full Time (San Francisco Bay area)

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

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



1) Director, International Regulatory Affairs – Full Time (San Francisco or Greater Bay Area) X113FP

DESCRIPTION:

  • Support the development of complex global regulatory filing strategies for International submissions for multiple projects.  
  • Leadership in the strategy, implementation, and maintenance of commercial programs globally; management/development of internal regulatory staff; representation in corporate relationships regarding regulatory affairs; and other duties as assigned.
  • Oversee the development and execution of global regulatory filing strategies for international submissions (e.g. MAs, ODDs, variations/supplements etc..) in line with corporate/department goals
  • Ensure regional teams are appropriately supported from the US on all filing activities
  • Collaborate closely with teams to ensure strategic alignment on projects/submissions, and compliance with department best practices/policies
  •  Oversee the lifecycle of approved licenses (e.g., updates to the administrative, labeling, nonclinical, and clinical portions of approved MAs)
  • Manage and support the development of junior team members
  • Interact with regulatory counterparts at partner companies and/or consultants as applicable
  • Oversee regulatory intelligence activities for product registrations and other submissions, including working with regional RA teams to monitor the regulatory environment for new developments or changes that could impact ongoing filings and/or approved licenses
  • Support preparation for agency meetings and may serve as a primary liaison if needed
  • Participate in multiple project and functional area team meetings in order to successfully liaise and influence internal/external stakeholders and communicate critical aspects of ongoing project activities

EXPERIENCE AND QUALIFICATIONS:


  • Proven ability to manage critical projects as part of an interdisciplinary team, including major regulatory submissions, with the ability to successfully manage projects to deadlines.
  • Possess thorough understanding of relevant drug development and post-marketing regulations and guidelines and to have outstanding interpersonal and communication (written and verbal) skills and effective task planning and coordination abilities.
  • Possess excellent communication skills in order to successfully liaise and influence internal/external stakeholders and communicate critical aspects of ongoing project activities.
  • Proficiency with computer and standard software programs is required.
  • Candidate must be fluent in English, both verbal and written (technical). 
  • Fluency in other language(s) is a plus.
  • Up to 10% travel expected
  • Must have 5-8 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the international regulatory environment
  • 3-5 years management experience
  • BA/BS degree, life sciences preferred.

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

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2) Analytic Biochemist – Contract (San Francisco Bay Area) 6924A73

DESCRIPTION:

  • Laboratory experience including the use of micropipettors (manual and electronic), microcentrifuges and capillary electrophoresis (CE).
  • Experience with a variety of laboratory devices and instrumentation, including PCR, flow cytometry, microtrac particle analysis instruments.
  • Hands-on experience required in executing, optimizing and troubleshooting current molecular biology techniques (DNA sequencing, PCR, cloning, and DNA hybridization) would be highly regarded in consideration for this position.
  • In addition to impeccable technical skills, successful candidates possess strong organizational, communication and team skills, and thrive in a fast-paced environment.
  • Summarize and communicate data and presentations using MS Excel, Powerpoint and Word software independently

EXPERIENCE AND QUALIFICATIONS:

  • Extremely motivated and be willing to work in a fast-paced environment, hard-working and multidisciplinary team
  • Resourceful and flexible
  • Adept at planning, prioritizing, multi-tasking, organizing and following through, while remaining highly energetic and focused
  • Straightforward, self-motivated, and trustworthy
  • Energetic and willing to work hands-on in developing and executing a variety of activities.  
  • Minimum BS, MS or higher preferred in Biology, Biochemistry, Molecular Biology or related fields and minimum 2 years
  • Preferred 3+ years research laboratory experience

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

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3) Associate Product Manager – Contract (San Francisco Bay Area) 73B6198

DESCRIPTION:

  • Assist in gathering new product, customer, market and regulatory requirements for creating business plans. 
  • Conduct voice of customer / market research projects.
  • Become proficient with product portfolio to support sales, tech support and service groups; 
  • Support global supply chain management activities, forecasting, planning, product quality and pricing analysis tasks.
  • Work with market development for managing sales collaterals, updating and creating web content.

EXPERIENCE AND QUALIFICATIONS:

  • Ability to develop relationships and work effectively with all internal stakeholders 
  • Ability to take directions, learn fast and execute support strategies effectively. .
  • Ability to work effectively in a fast-paced, 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 
  • Attention to detail, strong follow-through 
  • Strong communication and presentation skills
  • Bachelor's Degree (B.S./B.A.) in a scientific discipline (molecular biology, genetics or biochemistry preferred), or MBA with work experience in the biotechnology industry
  • Excellent verbal and written communication skills required
  • At least 1 year of experience in a product management role
  • At least 1+ year of related experience (life science research, product development, application/ technical support role)
  • Real-time instrument or software experience preferred

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

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4) Clinical Trial Manager / Sr. CTM - Oncology – Contract (San Francisco or Greater Bay Area) G82KZ

DESCRIPTION:

  • Manage and lead all aspects of one or more oncology Phase 1 to 4 clinical trials including, but not limited to protocol development to final report, clinical operations support for trial start-up, conduct, and close-out activities in order to achieve program objectives and goals.  
  • Collaborate with Clinical Contracts/Budget to manage efforts for clinical service provider selection. 
  • Lead clinical trial project execution for oncology programs to ensure that trial timelines, costs, and quality metrics are met.
  • Serves as primary contact for functional area representatives in managing protocol execution.
  • Manage the financial aspect of clinical trials to ensure accuracy and timeliness of service provider and site payments.
  • Forecast and oversee clinical supplies, e.g. study drug.
  • Manage study milestones to ensure accurate tracking and reporting of study metrics.
  • Oversee ongoing service provider management (CROs, IVRS), including independent negotiation of scope of work, budgets, performance management, and issue resolution.
  • Create and manage clinical trial budgets in collaboration with the VP of clinical operations.
  • Provide study-specific direction and mentoring to CRAs and CTAs. 
  • Collaborate with clinical Quality Assurance to maintain quality standards in compliance with regulatory requirements/guidance’s and adherence to SOPs and ICH/GCPs; participate in ongoing process improvement initiatives.
  • Manage adherence to ICH/GCP/local regulations.
  • Participate in clinical operations initiatives and programs.
  • Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.

EXPERIENCE AND QUALIFICATIONS:


  • Broad and current knowledge of regulations, clinical development process and oncology.
  • 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 includes Word, Excel, PowerPoint, and Outlook.
  • Working knowledge of MS Project for development and update of clinical study timelines. 
  • Willing to travel – anticipate up to 25%.
  • Bachelor’s Degree with at least 5 years of CRA experience for the manager level.  The senior manager level requires 8+ years of combined CRA and CTM experience.  At least 2 years direct staff management experience is required.

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

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5) Clinical Trial Assistant – Full Time (San Francisco or Greater Bay Area) AP82R

DESCRIPTION:

  • Responsible for performing multiple tasks that support clinical trials with duties that include, but not limited to:  assist clinical operations staff with activities related to clinical trials, create and maintain documents and tracking systems, maintain accurate files and filing systems, etc. 
  • Assist the clinical operations team to initiate, conduct, and complete Phase I-IV clinical trial activities. 
  • Provide accurate and up-to-date site information to operations team and cross-functional collaborators as needed.
  • Develop and implement accurate tracking systems, forms, and other relevant documents to support clinical trial studies.
  • Develop and maintain non-clinical supply materials such as study supportive documents, reference manuals (study reference and pharmacy manuals, initial site regulatory binder).
  • Order non-clinical supply materials and generate, maintain tracking of these materials.
  • Request and track investigator payments, as needed. 
  • Work with Clinical Operations and Finance to resolve payment issues. 
  • Creation of studies within the system per SOPs, tracking study specific data, and generate reports.
  • Assist in the distribution of key clinical trial documents (i.e. Investigator Brochures, protocols, informed consents, regulatory submissions).
  • Receive and review regulatory documents from clinical sites.  
  • Maintain effective tracking systems and communication with internal and external customers to ensure updates of appropriate regulatory documents (i.e. 1572s, financial disclosures).
  • Coordinate documentation for clinical study supply releases with investigator sites and ensure that regulatory is provided with appropriate documentation of approved investigator sites which will allow centers to be opened, e.g. IRB/EC approvals.
  • Submit and track essential documents to the Trial Master File (TMF) on an ongoing basis and perform periodic review of TMF and clinical development documents throughout the project life for completeness and accuracy. 
  • Maintain files of clinical trial documents for ongoing projects and assist in the archival of CRO study files and legacy documentation. 
  • Coordinate logistics for study meetings, medical expert meetings, investigator meetings, kick off meetings. 
  • Prepare draft minutes from the various meetings for review and finalization by the study team.
  • Assemble documents and supplies as needed to support monitoring visits.
  • Supports the organization in maintaining a work environment focused on quality and that fosters learning, open communication, collaboration, integration, and teamwork.

EXPERIENCE AND QUALIFICATIONS:

  • Knowledge of ICH GCPs and other applicable regulatory requirements.
  • Excellent interpersonal and organizational skills as well as the ability to effectively prioritize tasks.
  • Strong problem-solving skills and ability to work independently as well as work collaboratively in a team-oriented environment.
  • Makes effective use of the resources at hand.
  • Effective oral and written communication skills.  
  • Must be able to communicate effectively with members of other departments and with study site personnel as needed.
  • Proficient with computer applications such as Word, Excel PowerPoint and the ability to learn other applications with appropriate training.
  • A BS degree in life science or nursing with 1 to 2 years’ experience as a clinical trial assistant or study coordinator.  Or, an associate degree or equivalent with 4 years of clinical trial experience; specifically working with regulatory documents, tracking documents or as a clinical trial assistant.

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

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6) Training Analyst – Contract (New Jersey) 0813

DESCRIPTION:

  • Maintain quality standards and a state of audit readiness
  • Develop and implement priority learning solutions that will support company processes & procedures
  • Creates and  maintains job types and roles in the system
  • Generates training compliance reports
  • Analyzes  compliance reports, identifies gaps,  escalates any potential concerns and  ensures corrective action in put in place
  • Provide compliance reports as requested during internal & FDA Audits
  • Interfaces with training leads and provide support and expertise 
  • Consults internal quality document author/SMEs and creates elearning modules using various technologies i.e. Adobe Connect, Articulate, Brainshark
  • Consults internal quality document author/SMEs and instructor led training courses
  • Manages the administration related 
  • Monitors source data to ensure both employee and contractor are accurate
  • Ability to pull information from multiple data sources and create custom reports using excel
  • Monitors training compliance and escalates any issues
  • Manage the planning, implementation and close-out of  learning events
  • Creates and Administers course evaluation via electronic survey tool
  • Maintain training content (electronic and hard copy)
  • Create and maintain the training intranet site and Sharepoint Site 
  • Manages the design, development, planning & implementation web based training courses
  • Manages the design, development, planning & implementation for  instructor-led learning events (face to face and virtual participation) including training announcement/invitation, enrollment tracking, course confirmation and participation tracking
  • Manages and ensures accurate attendance tracking
  • Manage the planning, development implementation, close-out and evaluation of learning events

EXPERIENCE AND QUALIFICATIONS:

  • Knowledge of SOPs & other quality documents
  • Expertise in Course Design
  • High level of expertise in Le@rn Learning Management System (Saba based LMS)
  • Expertise in learning technologies i.e. Articulate; Adobe Connect, Brainshark, and Storyline
  • Expertise in MS PowerPoint, MS Excel, and Survey Monkey
  • Expertise in Sharepoint and Interwoven
  • Excellent communication skills         
  • 3-5 years of experience working in the pharmaceutical Industry
  • 3-5 years of experience working in the training Industry
  • 3-5 years of experience designing and developing instructor led-courses and web-based training courses
  • B.A/B.S Diploma

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

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7) Quality Engineer III – Full Time (Maryland) RL73G

DESCRIPTION:

  • Demonstrated knowledge and understanding of the Quality System Regulations (QSR), ISO 13485, requirements and other related regulations in regards to New Product Introduction/design transfer projects.
  • Lead team projects and assignments for New Product Introduction processes with minimal supervision.
  • Drive change for continuous process improvement.
  • Functions as an integral member of the design transfer team
  • Provides input during the development of specifications, design control, design verification, design validation, equipment acquisition, sample plan definition, test method validation, failure mode effects analyses, and design reviews and transfer processes through review and approval of the applicable design control processes.
  • Participates in new product development/design transfer team meetings, technical design reviews, and phase gate design review meetings to contribute quality assurance requirements and considerations.
  • May lead quality planning activities for new product development.
  • May lead risk management activities throughout the product lifecycle, including new product development and post production risk management.
  • Coordinates and communicates with internal supply chain management and manufacturing groups and external suppliers to ensure timely corrective action when purchased goods and services do not meet requirements as associated with design transfer
  • Ensure the effective development and qualification of inspection and test methods and equipment with respect to design transfer.
  • Provides input to the management review process for systems assigned to Design Quality Assurance.
  • Contributor to FDA and other agency factory inspections.
  • Ability to provide leadership to others in the organization through influence, innovative practices and teaching skills to foster a corporate culture that of responsiveness, compliance awareness, self-regulation, quality system ownership, challenge of status quo, and continuous improvement in order to achieve the highest level of compliance.
  • Manage & implement quality related projects with minimal supervision.
  • Identifies & develop realistic solutions to meet needs & solve problems.

EXPERIENCE AND QUALIFICATIONS:

  • Demonstrated ability to manage & implement projects with minimal supervision.
  • Requires the ability to perform independently & as part of a team.
  • Excellent communication and presentation skills
  • Experience of class III medical devices preferred
  • ASQ certification or equivalent formal training and experience preferred.
  • QMS auditing experience
  • Possesses excellent organizational, time management and multi-tasking skills in order to meet commitments and deadlines.
  • Good oral and written interpersonal communication skills to effectively communicate with cross functional multisite team.
  • Proficiency with personal computers, business software (MS Office) and technical software (e.g., Quality Management System (QMS) software), including software programs generating reports and statistics.  
  • Ability to create, use and interpret scientific tables, charts, and graphs.
  • Competence in basic statistical methodologies and tools for analyzing data, and identifying and communicating the frequency, severity, and distribution of trends.
  • Excellent problem solving methodology, using industry accepted concepts and tools to solve problems in creative and effective ways as they apply to compliance issues.
  • Possesses a strong scientific and technical background, sufficient to establish credibility with management as well as the manufacturing and product development teams
  • 5 years’ experience in the medical device, including medical device design, manufacturing & quality assurance / quality systems field. 
  • Bachelors of Science degree required (engineering, technical, or life sciences field strongly preferred).

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

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8) Quality Engineer III – Full Time (Maryland) RL73G

DESCRIPTION:

  • Demonstrated knowledge and understanding of the Quality System Regulations (QSR), ISO 13485, requirements and other related regulations in regards to New Product Introduction/design transfer projects.
  • Lead team projects and assignments for New Product Introduction processes with minimal supervision.
  • Drive change for continuous process improvement.
  • Functions as an integral member of the design transfer team
  • Provides input during the development of specifications, design control, design verification, design validation, equipment acquisition, sample plan definition, test method validation, failure mode effects analyses, and design reviews and transfer processes through review and approval of the applicable design control processes.
  • Participates in new product development/design transfer team meetings, technical design reviews, and phase gate design review meetings to contribute quality assurance requirements and considerations.
  • May lead quality planning activities for new product development.
  • May lead risk management activities throughout the product lifecycle, including new product development and post production risk management.
  • Coordinates and communicates with internal supply chain management and manufacturing groups and external suppliers to ensure timely corrective action when purchased goods and services do not meet requirements as associated with design transfer
  • Ensure the effective development and qualification of inspection and test methods and equipment with respect to design transfer.
  • Provides input to the management review process for systems assigned to Design Quality Assurance.
  • Contributor to FDA and other agency factory inspections.
  • Ability to provide leadership to others in the organization through influence, innovative practices and teaching skills to foster a corporate culture that of responsiveness, compliance awareness, self-regulation, quality system ownership, challenge of status quo, and continuous improvement in order to achieve the highest level of compliance.
  • Manage & implement quality related projects with minimal supervision.
  • Identifies & develop realistic solutions to meet needs & solve problems.

EXPERIENCE AND QUALIFICATIONS:

  • Demonstrated ability to manage & implement projects with minimal supervision.
  • Requires the ability to perform independently & as part of a team.
  • Excellent communication and presentation skills
  • Experience of class III medical devices preferred
  • ASQ certification or equivalent formal training and experience preferred.
  • QMS auditing experience
  • Possesses excellent organizational, time management and multi-tasking skills in order to meet commitments and deadlines.
  • Good oral and written interpersonal communication skills to effectively communicate with cross functional multisite team.
  • Proficiency with personal computers, business software (MS Office) and technical software (e.g., Quality Management System (QMS) software), including software programs generating reports and statistics.  
  • Ability to create, use and interpret scientific tables, charts, and graphs.
  • Competence in basic statistical methodologies and tools for analyzing data, and identifying and communicating the frequency, severity, and distribution of trends.
  • Excellent problem solving methodology, using industry accepted concepts and tools to solve problems in creative and effective ways as they apply to compliance issues.
  • Possesses a strong scientific and technical background, sufficient to establish credibility with management as well as the manufacturing and product development teams
  • 5 years’ experience in the medical device, including medical device design, manufacturing & quality assurance / quality systems field. 
  • Bachelors of Science degree required (engineering, technical, or life sciences field strongly preferred).

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

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9) Analytical Research Associate – Contract (San Francisco or Greater Bay Area) J129FM

DESCRIPTION:

  • Organize, perform and report on high performance liquid chromatography (HPLC), spectrophotometric or other assay and purity measurements of pharmaceutical development candidates as well as related substances or excipients.
  • Appropriately follow test methods, experimental protocols and review procedures.
  • Plan and organize experiments to meet specific technical objectives.
  • Adhere to company procedures and policies for laboratory documentation, safety, and quality
  • Use good scientific judgment in all activities.
  • Participate in group and individual meetings to establish priorities and organize activities and communicate results.

EXPERIENCE AND QUALIFICATIONS:

  • Knowledge of quantitative high performance liquid chromatography (HPLC) theory and practice as well as other analytical techniques used in the pharmaceutical industry.
  • Experience working with protein analysis and characterization using state of the art methodologies is a plus.
  • Knowledge of Chemstation and Chromeleon software is a plus.
  • Knowledge of Good Laboratory Practices and/or Quality Control related cGMP’s.
  • Must be able to work safely in an analytical/bio-analytical laboratory with inherent safety issues such as chemicals, and infective agents
  • Bachelor or higher degree in Chemistry, Pharmaceutics, Biology or related major.
  • At least 2-5 years relevant laboratory experience including HPLC analysis.

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

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10) Manager, Regulatory Affairs – Full Time (San Francisco or Greater Bay Area) BZ129H

DESCRIPTION:

  • Develops and executes regulatory plans for the coordination and preparation of documents that are submitted to U.S. and international regulatory authorities, support of INDs, BLAs, DMFs, CTAs, and necessary amendments, safety reports, supplements and annual updates
  • Contributes to or leads authoring, review, approval, compilation, and publishing of regulatory submissions; including CMC documentation, clinical documentation, safety reports and documentation related to investigational drug shipments.  
  • Perform gap analysis and propose solutions.
  • Regulatory representative for specific drug development project teams with responsibility for developing or contributing to regulatory strategies and requirements
  • Establishes appropriate communication within RA and other functions primarily at project level.  
  • Represents or leads the RA function on assigned cross-functional project teams.  
  • Ensures that regulatory expectations are clear to all internal and external stakeholders (including partners, CROs, CMOs, consultants, and contractors) in order to execute program objectives in compliance with applicable regulations  
  • Ensures 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
  • Monitors applicable regulatory requirements; assures compliance and external standards.  
  • Identifies potential compliance issues and works with respective functions in developing corrective action plans to ensure compliance is achieved

EXPERIENCE AND QUALIFICATIONS:

  • Experience with late phase drug development and commercial product regulatory requirements  
  • Experience with eCTD, e-publishing systems, and direct experience in preparing regulatory submissions, including BLAs or NDAs, is required  
  • Working knowledge of FDA regulations is required and experience with supporting global clinical studies is desired
  • Must possess excellent written and verbal skills (articulate and persuasive)
  • Self-starter and team player
  • Biologics experience required.
  • Bachelor or Master’s degree in a scientific discipline
  • Minimum of 5 years of experience in drug development/regulatory affairs in the biopharmaceutical industry

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

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11) Associate Director Clinical Operations – Full Time (San Francisco or Greater Bay Area) RA140Y

DESCRIPTION:

  • Direct clinical study implementation at a program level according to Good Clinical Practice (GCP) and Standard Operating Procedures
  • No direct reports
  • Provide leadership and support for clinical study execution with an emphasis on late stage clinical trials in complex diseases such as pulmonary, CNS, and immunology.
  • Responsible for providing operational input and oversight in designing, planning, initiating and completing clinical trials across a program level. 
  • Expected to take the lead in writing clinical documents including but not limited to study protocols, investigator’s brochures, and clinical study reports. 
  • Develop and coordinate operational plans for a clinical study or multiple clinical studies within a development program
  • Effectively lead the Clinical Operation Study Team(s) including in-house team members and those from Contract Research Organizations (CROs), vendors and other suppliers.
  • Work with various in-house functional groups with regards to operational issues of clinical studies including, for example, vendor oversight, safety reporting and processing, study drug supply plans, and clinical monitoring.
  • Manage the progress of clinical studies and ensure adherence to study protocols, regulatory and internal operating procedures, intended timelines and budget. This includes reviewing site recruitment, initiation and patient enrollment progress and review and act on trending reports.
  • Disseminate clinical project communications to appropriate functional groups
  • Provide mentorship to junior staff and take on line management responsibilities for clinical operations staff when called upon
  • Duties also will include participating in or leading cross functional initiatives aimed at developing or improving clinical operation process and standard operating procedures, and will be asked to take on functional level responsibilities as needed under the guidance of the Head of Clinical Operations

EXPERIENCE AND QUALIFICATIONS:

  • Master level understanding of the clinical study implementation process.
  • Strong understanding of CFR and ICH guidelines.
  • Excellent oral and written communication skills 
  • Exceptional interpersonal and leadership skills with proven ability to effectively work within a multidisciplinary team.
  • Willingness to travel up to 30%, as necessary, consistent with study or functional needs.
  • Position requires a minimum of a Bachelor of Science degree and at least 14 years of clinical management experience, including 6 to 8+ years of phase 3 study management experience within a pharmaceutical or biotech environment or relevant CRO experience. 

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

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12) Sr. Manager / Associate Director/Director, CMC Project Management – Full Time (San Francisco or Greater Bay Area) A82FY

DESCRIPTION:

  • Responsible for project management and planning of CMC-related product/process development activities including but not limited to new product development, analytical methods development/validation, process improvements, and product characterization. 
  • Work with 3rd parties when necessary (suppliers and CMOs) as well as  manufacturing site. 
  • Other responsibilities may include support of budgeting, regulatory submissions, supply chain, and operational excellence projects. 
  • The position will lead or participate on cross-functional teams with Technical Operations, Quality, Regulatory, and other functions.
  • Partner with Technical Operations, Quality, Regulatory, third party suppliers, corporate partners, and other functions to develop and execute technical CMC project plans.
  • Lead cross-functional teams through intensive schedule planning sessions to ensure appropriate identification of cross-functional project interdependencies.
  • Contribute to overall CMC strategy and setting appropriate goals/milestones.
  • Manage resource planning, risk management, contingency planning, project reporting, meeting priorities/agendas.
  • Develop and use appropriate project management tools and reports depending on the specific circumstances.
  • Proactively identify issues, risks, and opportunities, and make recommendations for improvement, mitigation, or changes; facilitate resolution of issues.
  • Work with multiple functions to prepare regulatory submissions or other correspondence with agencies
  • Collaborate with finance and other functions to support the budgeting process.
  • Establish and maintain a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork. 

EXPERIENCE AND QUALIFICATIONS:

  • Exceptional analytical and problem solving skills; extensive scientific, regulatory, and/or technical knowledge pertaining to pharmaceutical development or operations
  • Good judgment; exceptional interpersonal skills with emphasis on diplomacy, negotiation and ability to work in a team-based setting
  • Effective communication skills; flexibility; self-confidence, achievement-oriented with appropriate concern for quality are highly desirable qualifications.
  • Project management experience in CMC-related projects.  Solid understanding of CMC development milestones from Phase I to Commercialization.
  • Current knowledge of FDA regulations, guidelines, policies; demonstrated knowledge on evolving regulatory CMC requirements.
  • Ability to handle multiple projects and priorities with exceptional organizational and time management skills.
  • Proven experience using Project Management software (MS Project) to manage complex project timelines and resources, and excellent skills at Excel, Visio, and PowerPoint.
  • Ability to create presentations for internal and external use.
  • Ability to effectively manage meetings (agenda, actions, presentations, status reports).
  • Ability to perform in a fast-paced environment under tight deadlines.
  • Able to advise senior management and participate in the strategic development of the company.
  • Able to lead and contribute to strategic interactions and partnerships with outside collaborators.
  • BS or graduate degree in life sciences.  For the Sr Manager, 5 to 8 years’ CMC project management experience, including experience in one or more of the following:  Biological/Pharmaceutical Process Development, Product Characterization, Manufacturing, Quality Control, Analytical Development/Validation, CMC-Regulatory.  For the Associate Director, 8+ years’ experience and for the Director, 12+ years.

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

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13) Project Coordinator II – Contract (New Jersey) 0250

DESCRIPTION:

  • Review and maintain portfolio of Regulatory Operations business system projects 
  • Support logistical and administrative duties, such as contractor procurement and on-boarding; tracking and reconciling budgets; expenses; other activities related to outsourcing of system project personnel 
  • Gather up-to-date information from project managers / teams to maintain accurate inventory 
  • Arrange complex domestic and international travel and coordinate with related internal and external resources 
  • Prepare travel expense reports for domestic and international travel

EXPERIENCE AND QUALIFICATIONS:


  • Strong knowledge of MS Office  and web based applications 
  • Previous experience working with database systems and applications
  • Extensive knowledge in MS Outlook, MS Word, MS PowerPoint, MS Excel (MS Project and MS Access a plus) 
  • Excellent verbal and written communication skills 
  • Excellent organizational and interpersonal skills 
  • Must be pro-active, self-motivated, and results-oriented; able to take initiative and assume responsibility of tasks 
  • Must be detail-oriented and able to handle various tasks and changing situations in parallel 
  • Must be able to work in a multicultural environment   
  • 2+ years of project coordination and/or office management experience
  • Bachelors in related field

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

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14) Sr. Manager / Associate Director/Director, CMC Project Management – Full Time (San Francisco or Greater Bay Area) A82FY

DESCRIPTION:

  • Responsible for project management and planning of CMC-related product/process development activities including but not limited to new product development, analytical methods development/validation, process improvements, and product characterization. 
  • Work with 3rd parties when necessary (suppliers and CMOs) as well as  manufacturing site. 
  • Other responsibilities may include support of budgeting, regulatory submissions, supply chain, and operational excellence projects. 
  • The position will lead or participate on cross-functional teams with Technical Operations, Quality, Regulatory, and other functions.
  • Partner with Technical Operations, Quality, Regulatory, third party suppliers, corporate partners, and other functions to develop and execute technical CMC project plans.
  • Lead cross-functional teams through intensive schedule planning sessions to ensure appropriate identification of cross-functional project interdependencies.
  • Contribute to overall CMC strategy and setting appropriate goals/milestones.
  • Manage resource planning, risk management, contingency planning, project reporting, meeting priorities/agendas.
  • Develop and use appropriate project management tools and reports depending on the specific circumstances.
  • Proactively identify issues, risks, and opportunities, and make recommendations for improvement, mitigation, or changes; facilitate resolution of issues.
  • Work with multiple functions to prepare regulatory submissions or other correspondence with agencies
  • Collaborate with finance and other functions to support the budgeting process.
  • Establish and maintain a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork. 

EXPERIENCE AND QUALIFICATIONS:

  • Exceptional analytical and problem solving skills; extensive scientific, regulatory, and/or technical knowledge pertaining to pharmaceutical development or operations
  • Good judgment; exceptional interpersonal skills with emphasis on diplomacy, negotiation and ability to work in a team-based setting
  • Effective communication skills; flexibility; self-confidence, achievement-oriented with appropriate concern for quality are highly desirable qualifications.
  • Project management experience in CMC-related projects.  Solid understanding of CMC development milestones from Phase I to Commercialization.
  • Current knowledge of FDA regulations, guidelines, policies; demonstrated knowledge on evolving regulatory CMC requirements.
  • Ability to handle multiple projects and priorities with exceptional organizational and time management skills.
  • Proven experience using Project Management software (MS Project) to manage complex project timelines and resources, and excellent skills at Excel, Visio, and PowerPoint.
  • Ability to create presentations for internal and external use.
  • Ability to effectively manage meetings (agenda, actions, presentations, status reports).
  • Ability to perform in a fast-paced environment under tight deadlines.
  • Able to advise senior management and participate in the strategic development of the company.
  • Able to lead and contribute to strategic interactions and partnerships with outside collaborators.
  • BS or graduate degree in life sciences.  For the Sr Manager, 5 to 8 years’ CMC project management experience, including experience in one or more of the following:  Biological/Pharmaceutical Process Development, Product Characterization, Manufacturing, Quality Control, Analytical Development/Validation, CMC-Regulatory.  For the Associate Director, 8+ years’ experience and for the Director, 12+ years.

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

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15) Project Manager III – Contract (New Jersey) 4155

DESCRIPTION:

  • Acts as the training lead within a project team member for a technical or process project. 
  • Able to leads, organize and execute all phases of a training project: 
  • Analyze training needs with the requestors / customers 
  • Develop a training proposal (training approach / strategy, timelines, and resources)
  • Prepare outsourcing in liaison with purchasing and legal
  • Design and develop training programs including content description, sustainable learning delivery methods, customized learner paths, training program communication and evaluation. 
  • Experience with training program design in respect to implementation of blended/multi-part/complex learning solutions in an LMS
  • Develop training content and all associated media
  • Maintain the training programs after deployment. Update training materials when needed and communicate to trainers 
  • Coordinate the training deployment (including the coordination and support of the local trainer networks) 
  • Develop and evaluates learning to determine gains in knowledge and skills, application and transfer, and overall impact/ROI
  • Ensure development and implementation of standard methodologies in training 

EXPERIENCE AND QUALIFICATIONS:

  • Strong knowledge of clinical drug development process and operations.
  • Experience establishing learning management system standards and processes to improve quality and operational efficiency. 
  • Excellent organizational, project management and prioritization skills. 
  • Experience with training development in an Agile project model a plus.
  • Self-directed with a strong team orientation. 
  • Understand the fundamentals of adult learning theory. 
  • Ability to multi-task and achieve multiple objectives simultaneously. 
  • Flexibility to adapt to busy working environment with changing priorities and deadlines. 
  • Strong presentation skills, excellent written and verbal skills.
  • Excellent knowledge of training development and authoring tools (including Articulate Studio, Storyline and Adobe Captivate). 
  • Excellent interpersonal, organizational, and oral-written communication skills in English. 
  • French fluency is a plus. 
  • Able to listen to customers and apply accuracy, precision, logic and a systematic approach to all phases of a training project.
  • Experience with Action Mapping a plus. 
  • Interact efficiently in a multicultural environment. 
  • Provide examples of course design experience.
  • BS preferably in Scientific or Technical discipline, MS preferred. 
  • 6+ years experience as a Training Manager - experienced in both process and technical training.
  • 4+ years experience in the Pharmaceutical Industry, preferably in Clinical Research areas

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

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16) CMC Project Manager (Sr. Manager / Associate Director Level) – Full Time (San Francisco or Greater Bay Area) MB157J

DESCRIPTION:

  • Manage Chemistry, Manufacturing and Control (CMC) activities for projects at all development stages, interfacing with relevant functional groups (quality, device, regulatory, and clinical operations) and with external vendors. 
  • Plan and coordinate the timely execution of CMC activities and contingencies. 
  • In partnership with the VP of Manufacturing, establish project management strategies and standards in alignment with CMC and corporate business plans.
  • Contribute and lead the operational implementation of CMC strategy

EXPERIENCE AND QUALIFICATIONS:

  • Have successfully managed activities for CMC-related projects, developed detailed timelines, minutes and budgets for projects in collaboration with functional leaders, and facilitated alliances between the company and its business partners. 
  • Lead the efforts to critically assess the strategic options for projects and has presented to the CMC team and senior managers, the proposed path forward and recommendations to maximize value 
  • This role has a high level of job complexity and the successful candidate must have a thorough knowledge of CMC-biologics related activities. 
  • Strong relationship building skills and have proven expertise in managing partnerships with various CMC-related vendors, including large scale contract manufacturing organizations (CMOs) as well as collaborating with other related functions in the oversight of contract service organizations
  • Education in a scientific field along with CMC project management expertise 

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

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17) CDM Systems Project Manager – Contract Position (San Francisco or Greater Bay Area) RP156B

DESCRIPTION:

  • Will report to the head of Clinical Data Management Systems, a liaison to both Clinical Data Management and/or Information Systems.  
  • Will review final testing scripts; Data management be the testors (testing team); Participate in review of output.
  • Will participate in the development of new and/or existing systems to support business processes.  
  • Expected to play the role project manager and business analyst.
  • Manages the project lifecycle from initiation, planning, execution, control, and close out.
  • Develop and implement project timelines that includes software validation and business process milestones 
  • Provide business sponsors, project team, and management with regular updates regarding project milestones
  • Must be able to identify existing or possible gaps in documentation and process, communicate these gaps in a format and structure appropriate for the intended audience
  • Identify and implement business process solutions
  • Responsible for the creation and/or review of user guides, training material, business process procedures and any other documentation required by the project
  • Responsible for user acceptance testing, defect reporting and resolution
  • Implement business process solutions by creating, delivering and training users on new business process and systems
  • Ensure business processes are stable after a new system implementation (or change) by understanding the impact of the changes on the process

EXPERIENCE AND QUALIFICATIONS:

  • Candidates must have worked in Clinical Operations, Clinical Data Management, or Safety at a Medical Device, Biotech or Pharmaceutical institution. 
  • Bachelor's degree plus 2-5 years of related work experience with a good understanding of specified functional area, or an equivalent combination of education and work experience.
  • 2+ years (Management) Consulting or Business Analysis experience

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

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18) Marketing Assistant – Contract (Southern California) 8266G73

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. 
  • 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. 
  • Works on tasks/duties that are considered relatively routine to diverse in nature, using developing technical and/or business knowledge. 
  • Has a strong ability to adapt to change very quickly, due to the dynamic nature of the scope of projects covered by the marketing group. 
  • Good prioritization capabilities, with an ability to see a task through to completion, despite the other project demands.

EXPERIENCE AND QUALIFICATIONS:

  • Computer savvy including Microsoft office, Excel and PowerPoint.  
  • Good communication skills.  
  • Strong organizational skills  
  • Science background, degree or experience       
  • 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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19) Project Coordinator II – Contract (New Jersey) 7352

DESCRIPTION:

  • Manage learner profiles in the LMS database; request, update, terminate as needed. 
  • Review/QC the profile database and correct/update errors
  • Manage the implementation of training curricula and assignment to learner roles; certifications, ad hoc assignments etc.
  • Run reports both standard and ad hoc, streamline report functionality, run queries for ad hoc requirements, propose dashboards as needed
  • Provide technical support to learners/users
  • Serve as point of contact for support issues
  • Serve as escalation contact between users and help desk support for all support issues
  • Support users in the use of the LMS as needed; accessing training, launching content, understanding basic functionality

EXPERIENCE AND QUALIFICATIONS:

  • Demonstrated experience in managing LMS/learning database systems. 
  • Experience in a regulated environment a plus
  • Demonstrated experience in a learning/training organization, experience with eLearning technologies desirable
  • Outstanding problem solving, analytical, organizational and time management skills
  • Strong Microsoft Office skills, Excel in particular. 
  • Comparable data management programs also acceptable. 
  • Experience working with MS Access a plus
  • Strong computer skills/advanced training with an emphasis on databases 
  • Knowledge of and demonstrated experience with reports software, building queries
  • Mastery in adult learning concepts and technology a plus
  • Good verbal and written skills
  • Demonstrated ability to work cross-culturally  
  • Experience in one or more content authoring tools is a plus; Articulate, Captivate, and Adobe
  • Bachelor’s Degree with an emphasis in computer science, information science or management information systems
  • Certification in database technology a plus

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

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20) Manufacturing Leader – Full Time (New York Area) NH73K

DESCRIPTION:

  • Experienced operations and business leader needed to drive a manufacturing site for GMP production of cell culture products including cell culture media, process liquids and sera for use in biopharmaceutical manufacturing and research. 
  • Report directly to the Vice President of Operations  
  • Responsibilities include an intense focus on meeting customer needs in a demanding cGMP environment, leading and ensuring all functions at the site are functioning at peak efficiency with proper internal communication and interfaces, developing the operations and manufacturing teams while ensuring delivery of high quality products which are in compliance with all applicable cGMP manufacturing regulations.
  • Coordinate the hiring, training, coaching and annual performance reviews of personnel.  
  • Facilitate and mentor the development of team members and front line leaders to be exceptional players.
  • Effectively use prioritization mechanisms to utilize resources across teams to complete required workload.
  • Lead managers and other site leadership across functions to achieve site goals.
  • Drive compliance to applicable US FDA and EC Quality System Regulations.
  • Establish key performance indicators that drive change and visibility to the team and leadership. Track, trend, and monitor routinely with active data analysis to target and drive results.
  • Monitor and manage progress on projects, ensuring key requirements and milestones are met.
  • Coordinate the development of action plans when corrective steps (CAPA) are required and implement these in a timely manner.
  • Manage budgets, schedules and key operating metrics.
  • Define and establish clear objectives and expectations, provide direct feedback routinely for performance management.
  • Identify projects and recommend appropriate course of action (e.g., discontinuation, outsource, process improvement) to maximize profitability and supply.
  • Execute robust risk management practices to maintain high probability of project success, satisfaction of scope, schedule and budget.
  • Responsible for assessing resource needs across multiple projects and working with appropriate managers to assign resources per established priorities.
  • Ensure effective transfers of new products into production that meet all the quality requirements for the classification.
  • Ensure site wide training is effective and that the team operates within the required regulatory guidelines by examining and testing plant-wide processes and products from a final product acceptance and compliance

EXPERIENCE AND QUALIFICATIONS:

  • Excellent communication and interpersonal skills both written and verbal and the ability to facilitate team interactions.
  • Strong leadership ability with the capability to leverage diverse resources, respond quickly, understand the impact of changes and decisions, facilitate agreement, build collaborative relationships and focus on customer needs.
  • Ability to work with individuals at all levels and within all functions to motivate strong results.
  • Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency.
  • Strong analytical ability including the ability to effectively use data in problem solving and to evaluate process changes and impacts.
  • Experience in leading an organization in a cGMP environment with a focus on Make to Order (MTO)/Custom products is desirable.
  • Audit experience within a cGMP environment with successful outcomes is valuable.
  • Ability to partner with and influence key stakeholders including Finance, R&D, Product Management and the Commercial team.
  • Must be able to independently manage multiple complex projects concurrently while meeting target dates.
  • Demonstrated experience as a change agent with ability to influence and communicate at all levels in the organization.
  • Experience in leading an organization in a cGMP environment with a focus on Make to Order (MTO)/Custom products is desirable
  • Audit experience within a cGMP environment with successful outcomes is valuable.
  • Bachelor's degree in related discipline and/or equivalent experience. 
  • Master's Degree is preferred
  • Minimum of 7 - 10 years of management experience in a complex manufacturing environment.  

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

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21) Senior Medical Director / Medical Director, Clinical Development – Full Time (San Francisco or Greater Bay Area) YS139B

DESCRIPTION:

  • Report to the Global VP of Clinical Development and matrix with members of the project team to assist in establishing the clinical development strategy for compounds: from the pre-IND setting to pivotal trials and registration. Aspects of the development strategy include study design, tissue sample collection, input to biomarker strategies, and integration of personalized medicine into the clinical development plan.  
  • Accountable for medical monitoring and patient safety and to provide medical guidance during the design, execution, and reporting of clinical studies and registration with health authorities.
  • Lead the formulation of clinical development plans, including selection of the proof of concept indications for specific projects. 
  • In collaboration with appropriate team members (e.g., clinical pharmacology, statistics, translational medicine, research), be responsible for the design of protocols and conduct of data review, analysis and interpretation.
  • Function in the role of medical monitor.
  • Ensure the medical and scientific quality of clinical trial protocols, case report forms, data and data listings, and clinical trial reports. 
  • Be accountable for safety across relevant studies, including regular review of safety data (including but not limited to SAEs) and response to safety issues.
  • Work closely with CRO, Clinical Operations and investigators/investigative sites to ensure data quality and patient safety.
  • Maintain working knowledge of GCPs and regulatory requirements relating to clinical development and safety compliance with ethical, legal and regulatory standards. 
  • Participate in proposal generation, feasibility assessments, and review of proposals/contracts for medical services.
  • Participate in the development and delivery of protocol training for investigator site and staff.
  • In conjunction with the CMO and Research group, prepare strategy presentations, present and discuss data at relevant team, governance, executive committee, external consultant, KOL, and regulatory meetings.
  • Author clinical sections of regulatory documents (IB, Annual Reports, IND sections, CSR).
  • Participate in preparation for and conduct of meetings with healthcare authorities.
  • Contribute to the overall strategy and preparation of documents to secure approval of drug, BLAs/NDAs/MAAs.
  • Lead or assist in preparation of manuscripts, abstracts and meeting presentations.
  • Responsible for the on-time and within-budget execution of protocols.
  • Organize and prepare for Board meetings.
  • Act as clinical representative for out-licensing/collaboration presentations and facilitation of due diligence with prospective partners, and in-licensing activities such as due diligence, report generation, and formulating development strategies.

EXPERIENCE AND QUALIFICATIONS:

  • Requires MD with a minimum of four years of demonstrated knowledge and experience in clinical research, preferably in an industry setting.
  • Strong basic science knowledge to enable proof-of-concept and PD biomarker design and interpretation.
  • Oncology fellowship training and active board certification within the last 5 years.
  • Understanding of related disciplines (e.g. biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences). 
  • Demonstrated scientific productivity (publications, abstracts, etc.).
  • Scientific writing skills and good communication skills.
  • Flexibility to work with colleagues in a matrixed setting.
  • Able to engage in work-related travel approximately 20%.

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

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22) Vice President, Regulatory Affairs – Full Time (San Francisco or Greater Bay Area) B139KZ

DESCRIPTION:

  • Provide counsel, training, and interpretation of FDA’s and other regulatory authorities’ feedback, policies and guidelines to personnel and assist as a liaison between company and regulatory authorities.
  • Assist in the design and interpretation of results for clinical studies required for regulatory approvals.
  • Develops regulatory strategic plans for project teams. Works with project teams to resolve complex project issues. Utilizes regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained. 
  • Represent company before regulatory authorities.
  • Responsible for filing of CTA/IMPD/IND/BLA submissions. Sets strategy for submissions of product registration documents to health authorities worldwide. Interacts with other line functions in the preparation, review, and completion of documents for regulatory submissions.
  • Responsible for keeping management team informed of regulatory status of products and significant regulatory issues. 
  • Able to present and implement project related regulatory strategy with all Project Teams. Assures compliance with project team timelines and milestones.
  • Effectively plan, organize, and conduct (or supervise) formal meetings with regulatory agencies. Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications.
  • Provide interpretive analyses of complex regulatory guidance documents, regulations, or directives that influence products and operations. Advise personnel in other departments regarding their applicability and impact.
  • Manage a team in Regulatory Affairs & Operations and have working knowledge of the Regulatory Operations function and submission logistics

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor’s degree in a Life Sciences discipline or equivalent, M.S. degree preferred.
  • Minimum of ten years of experience in clinical regulatory and minimum of seven years of progressive leadership experience.
  • Oncology background required.
  • Proven ability to develop and manage a high performance regulatory team focused on accountability and meeting and exceeding expectations.
  • Excellent track record for product approvals  in the US and EU
  • Extensive experience in cGMP and other Regulatory (CMC, preclinical) compliance requirements.
  • Possess a broad knowledge of biopharmaceutical manufacturing and operations.
  • Balance of strategic thinking and strong analytical skills with ability to execute. 
  • Experience with international regulatory submissions and an understanding of worldwide biologics guidelines and regulations preferred.
  • Detail oriented and results driven with strong written, verbal communication and presentation skills.
  • Demonstrated excellence in regulatory liaison/strategy
  • Strategic thinking, leadership skills, assertiveness, strong technical background, and excellent negotiation and project management skills as evidenced by past performance on drug development project teams
  • Able to analyze worldwide regulatory requirements to synthesize a global regulatory development strategy as evidenced by past regulatory experience
  • Excellent interpersonal skills
  • Excellent communication skills (verbal and written) as evidenced by a demonstrated ability to prepare complex documents / submissions and to give presentations
  • Significant management experience is preferred
  • Ability to work independently
  • Ability to travel (approximately estimated 20% travel required)

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

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23) Project Manager – Full Time (San Francisco or Greater Bay Area) DY113R

DESCRIPTION:


  • Manage regulatory team operations, including facilitation of team and strategy meetings (schedule, prepare/distribute documentation and ensure action item follow-up; meeting leadership often required).
  • Create and maintain regulatory timelines and ensure that they are functional, consistent and integrated to reflect cross-functional dependencies; create and maintain reporting dashboards for teams and management.
  • Track submission preparation progress, including but not limited to post-marketing and annual reporting commitments, to ensure timely filing to health authorities.
  • Document project milestones/deliverables and report progress against team, department, and corporate goals.
  • Facilitate short and long-term planning activities.
  • Analyze internal Regulatory Affairs and Project Management processes, identify opportunities for improvement.

EXPERIENCE AND QUALIFICATIONS:

  • Experience with MS Project 2010, or similar scheduling software, required or proven skill at adapting to new software/technology.  
  • MS Project Server experience helpful.
  • Pharma/biotech or related industry experience required.
  • Excellent interpersonal skills; adept at working as a part of an interdisciplinary team and skilled at negotiation and influencing others.
  • Knowledge of regulatory affairs submissions and nomenclature desirable.
  • Exposure to electronic document management system(s) (EDMS) helpful.
  • Bachelor’s degree required.
  • Project Management Professional and/or Regulatory Affairs Certification a plus.
  • At least 5 years’ experience in a project management or scheduling environment
  • Minimum of two years’ experience managing teams and team operations.

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

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24) Clinical Project Manager – Full Time (San Francisco or Greater Bay Area) XP127J

DESCRIPTION:


  • Responsible for the implementation and management of clinical studies from phase 1 to phase 4.
  • Leads clinical studies, from concept to protocol, and through the achievement of corporate objectives
  • Leads or supervises development of protocol and study documents, e.g. consent templates, site reference manuals, monitoring plan, pharmacy manual.
  • Prepares materials and provides study training, e.g. initial regulatory document package for sites, investigator meetings, vendor kickoff meetings, site initiation visits, ad hoc internal or external training. 
  • Participates in preparation and training for site QA, FDA or other regulatory inspections.
  • Participates in assessment and selection of Contract Research Organizations (CROs), sites, and other vendors; may perform qualification visits as needed, solicit and review proposals, review or negotiate budget and Scope of Work.
  • Assists with national (FDA, Competent Authority) and local IRB and submissions and subsequent responses.
  • Responsible for oversight of CROs and/or site monitors, sites and other vendors, ensures compliance with GCP/ICH, monitoring plan, protocol, and Scope of Work; initiates corrective and preventive action plans with as necessary.
  • Manages Trial Master File and Clinical Trial Management System (CTMS); responsible for reconciliation of the TMF when transferred from an external vendor.
  • Responsible for internal study-related reporting, communications and collaboration with other departments and vendors/consultants, including Regulatory Affairs, Quality Assurance, Clinical Drug Supply and Pharmacovigiliance.
  • May be responsible for development of site budget templates, negotiation of budget with sites, and facilitation of site clinical trial agreement negotiations.
  • Responsible for tracking and administration of investigator payments.
  • For assigned studies, develops and maintains a project management plan which tracks key study and program milestones, detailed enrollment tracking and contingency plans, and budget/resource assessment. 
  • MS Project experience required.
  • May review clinical documents (i.e. protocols, amendments, clinical study reports) and clinical sections of regulatory documents (i.e. IND annual reports, annual or periodic safety reports, IND and NDA filings) for accuracy, consistency and quality.
  • May be responsible for the supervision and/or mentoring of regional or in-house clinical operations personnel.
  • Develops and/or reviews clinical operations SOPs and departmental policies.

EXPERIENCE AND QUALIFICATIONS:

  • Strong communication skills and ability to liaise with multiple regional and external colleagues is necessary.
  • Must be able and willing to travel on a periodic basis.
  • Experience with Microsoft Office suite required (Word, Excel, Project, and Outlook).
  • Bachelor’s degree in a biological science is preferred.
  • 5-7 years’ experience in clinical development, with pediatric, orphan drug and/or rare disease knowledge very helpful.

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

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25) Research Assistant – Contract (San Francisco or Greater Bay Area) A127HM

DESCRIPTION:

  • DNA sequencing using a Sanger sequencing instrument.
  • Efficient execution of experiments designed to further research.
  • Maintenance of lab and laboratory equipment.
  • Maintain proper records of laboratory testing and results.
  • Organize and maintain files, folders, binders and electronic information.

EXPERIENCE AND QUALIFICATIONS:

  • Extensive experience in primers design, PCR, DNA sequencing, running Sanger sequencing instrument, instrument maintenance, Library construction, nucleic acid isolation.
  • Ability to carry out laboratory tasks, including running of lab equipment, in a safe and compliant manner.
  • Demonstrated ability to follow proper guidelines for safe handling of hazardous chemicals.
  • Comprehensive understanding of molecular biology concepts.
  • Ability to organize and prioritize work.
  • Strong communication skills.
  • Exceptional organizational skills.
  • Ability to work effectively with others at all levels inside and outside the organization.
  • Demonstrated ability to maintain a clean and efficient work area.
  • Exhibit flexibility and adaptability in dealing with unexpected circumstances that may occur.
  • Bachelor’s/Master’s degree in molecular biology, biochemistry or related field.
  • 1+ years’ experience in a research laboratory environment and experience using a Sanger sequencing instruments.

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

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26) Administrative Assistant I – Contract (New Jersey) 5155

DESCRIPTION:

  • Provides high level administrative support and project coordination support primarily to VP and and staff
  • Provides administrative support requiring a complete knowledge of department functions. 
  • Responsibilities include preparing grammatically correct correspondence, reports, tables, and analyses. 
  • Exercises discretion in handling of confidential material and information. 
  • Assists in special projects as assigned. 
  • Recommends improvements on administrative procedures and implements changes. 
  • Responsible for organization and maintenance of department filing system including potentially confidential data. 
  • Ensures department supplies needs are met. 
  • Manages department communication for managers including mail and email. 
  • Responds to various inquiries for information according to general guidelines. 
  • Coordinates meetings, maintains calendars, makes travel arrangements, etc. 
  • May provide clerical support as necessary, including filing, faxing, copying, performing data entry
  • May provide guidance and training to less experienced administrative staff. 
  • Completes other duties as requested. Interfaces with staff and senior level managers, internal/external customers and vendors. 
  • Ensures a smooth and efficient flow of day to day operations. 
  • Contacts are frequent with individuals representing other departments, and/or representing outside organizations. 
  • Contacts involve obtaining or providing information or data on matters of moderate importance to the function of the department or which may be of sensitive nature. 
  • Demonstrated ability in the application of requisite skills and applies additional skills and knowledge acquired through experience to perform the more complex tasks of the position. 

EXPERIENCE AND QUALIFICATIONS:

  • MS Office Suite; Concur; SAP; Sharepoint        
  • HS Diploma. College degree preferred

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

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27) SAS Programmer – Contract (New Jersey) 5029

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. 

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 5+ 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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28) Administrative Assistant III – Contract (Massachusetts) 2375

DESCRIPTION:

  • Provide daily proactive administrative support 
  • Responsible for maintaining calendars, coordinating meetings, processing purchase requests, and making global travel arrangements 
  • Regularly interfaces with senior management and staff to complete tasks 
  • Professionally interacts with external and internal parties. 
  • Responds to various inquiries for information according to general guidelines.
  • Prepares grammatically correct correspondence, reports, tables, and analyses 
  • May generate and format basic presentations 
  • Manages communications as requested, including telephone calls, meeting planning, email messages Schedules meetings/reserve conference rooms 
  • Performs online expense reporting processes and tracks invoices, establish P.O's.
  • Provides clerical support including filing, faxing, copying, scanning, mailing, and some data entry 
  • Oversees organization and maintenance of files including potentially confidential data.
  • Ensures supply needs are met, including online purchasing consistent with company SOPs 
  • May be asked to obtain sequential approvals, requiring an understanding and adherence to company SOPs  
  • Must have advanced knowledge of or quickly learn internal electronic systems to facilitate completion of tasks 

EXPERIENCE AND QUALIFICATIONS:

  • 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 
  • Strong communications and interpersonal skills; a team player 
  • Strong administrative and computing skills, MS Office (Outlook, PowerPoint, Excel and Word) 
  • Ability to anticipate needs, resourcefulness and responsiveness are essential 
  • Attentive to details and results 
  • High attention to detail and precision in creating reports, tables, and analyses.
  • Ability to interact with all employees within the organization, including senior management, and to respond effectively to the needs of the business are required.          
  • Bachelor's Degree-3-5 years' experience supporting senior-level business leaders in a pharmaceutical or biotech global environment, with an additional 5+ years supporting senior-level leaders in a non-pharmaceutical or non-biotech environment
  • 5+ years' experience using technology including Microsoft Office Suite, power point and excel

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

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29) (Senior) Manager, Regulatory Operations – Full Time (San Francisco or Greater Bay Area) JN113W

DESCRIPTION:

  • Oversee planning, scheduling, resource allocation, formatting, publishing (including QA), transmitting and archiving regulatory submissions in both paper and electronic media to health authorities in the US, EU, etc. 
  • Manage internal regulatory operations personnel as well as the activities of external consultants. 
  • Oversee the development and maintenance of processes, templates, standards, and guide sheets. 
  • Must be able to oversee applications and systems support (Livelink Knowledge Management), systems training programs, and supporting development projects within Regulatory Affairs. 
  • Other duties as assigned.
  • Interacts with regulatory affairs providing information to be submitted (including but not limited to Clinical, Nonclinical, and Quality).  
  • Requires the ability to exercise discretion, independent judgment and clearly identify priorities, as well as to work overtime in order to meet required timelines.

EXPERIENCE AND QUALIFICATIONS:

  • A minimum of 3- 5 years of experience in regulatory operations
  • A minimum of 2 years experience as a Manager with direct reports with no more than 5 years gap since having had direct reports
  • Must be highly proficient in MS Office 2007,MS Word, and Adobe Acrobat (version 5.0 or above preferred).
  • Experience with a publishing tool; Knowledge of Livelink and InSight Publisher preferred. 
  • Must have experience with electronic submissions, specifically eCTD.
  • The candidate should have proven ability to manage critical projects as part of an interdisciplinary team. 
  • Experience managing major regulatory submissions, with the ability to successfully manage projects to deadlines.
  • The candidate is expected to have a thorough understanding of relevant submission formatting, transmittal and archiving regulations and guidelines and to have outstanding interpersonal and communication (written and verbal) skills and effective task planning and coordination abilities.
  • Bachelor’s Degree desirable.

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

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30) CDM Systems Project Manager – Contract Position (San Francisco or Greater Bay Area) RP156B

DESCRIPTION:

  • Will report to the head of Clinical Data Management Systems, a liaison to both Clinical Data Management and/or Information Systems.  
  • Will participate in the development of new and/or existing systems to support business processes.  
  • This position will be expected to play the role project manager and business analyst.
  • Manages the project lifecycle from initiation, planning, execution, control, and close out.
  • Develop and implement project timelines that includes software validation and business process milestones 
  • Provide business sponsors, project team,  and management with regular updates regarding project milestones
  • Must be able to identify existing or possible gaps in documentation and process, communicate these gaps in a format and structure appropriate for the intended audience
  • Identify and implement business process solutions
  • Responsible for the creation and/or review of user guides, training material, business process procedures and any other documentation required by the project
  • Responsible for user acceptance testing, defect reporting and resolution
  • Implement business process solutions by creating, delivering and training users on new business process and systems
  • Ensure business processes are stable after a new system implementation (or change) by understanding the impact of the changes on the process

EXPERIENCE AND QUALIFICATIONS:

  • Candidates must have worked in Clinical Operations, Clinical Data Management, or Safety at a Medical Device, Biotech or Pharmaceutical institution. 
  • Bachelor's degree plus 2-5 years of related work experience with a good understanding of specified functional area, or an equivalent combination of education and work experience.
  • 2+ years (Management) Consulting or Business Analysis experience

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

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31) Director QA, GxP Quality Systems – Full Time (San Francisco or Greater Bay Area) F110JV

DESCRIPTION:

  • Responsible for developing and implementing GxP Quality Systems for drug/device combination products. 
  • Manage and/or through direct reports all aspects of GxP Quality functions through all phases of product development, clinical, commercial and life-cycle.
  • Serve as the key point of contact representing QA in various projects and liaising with various regulatory agencies for quality related matters.  
  • Provide strategic leadership, development and implementation of GxP QA Systems for drug/device combination aseptic products.
  • Develop and maintain a compliant Quality Management System to comply with applicable company, US and worldwide regulatory requirements including standards, guidance and procedures. 
  • Oversee and manage all aspects of quality functions for design review, Deviations and CAPA, Document and Change Control, Management and Product Quality Review Product Complaints, Risk Management and Failure  Analysis, Stability, Training and Validation (facilities, equipment, computer systems and processes).
  • Conduct periodic Product Quality and Management Review, including tracking, trending QA metrics and design action plans to address trends.
  • Identify, assess and communicate QA strategies, metrics, gaps and compliance risks to senior management.
  • Partner with Product Development, Regulatory Affairs, Clinical Research, external vendors and partners to support corporate objectives and ensure that the site complies with all quality, regulatory and compliance requirements.
  • Contribute to site PAI and commercial readiness preparations.  
  • Host and manage all regulatory audits; Federal, Notified Body for CE Mark, State including partner audits.
  • Oversee Supplier Qualification Program and ensure quality agreements are in place for key vendors and compliance to approved agreements.
  • Provide guidance on regulatory standards for compliance with CE Mark Technical Files/Dossiers.
  • Develop a high performing team to manage GxP QA responsibilities.  
  • Hold the team accountable for preparing and achievable tactical goals.
  • Prepare accurate budget and headcount forecasts for QA organization.
  • Oversee the QA organization within allotted budget and headcount.  
  • Provide training, development and growth opportunities for employees.

EXPERIENCE AND QUALIFICATIONS:

  • A minimum Bachelor’s degree in a scientific discipline is required. An advanced degree is preferred.
  • Seasoned professional in managing GxP Quality Systems (QA and QC) for drug/device combination aseptic products with a thorough knowledge of cGMP regulations (21CFR211, 21CFR820, EMA), ISO 13485, CE Marking and ICH guidance’s
  • Experience in oversight of implementing GxP computer systems with compliance to Part 11 and EU Annex 11 requirements.
  • Working knowledge of ICH risk management tools, Failure Mode Effects Analysis (FMEA), and/or lean/Six sigma concepts.
  • A minimum experience of 15+ years in the drug/device pharmaceutical and biopharmaceutical industry with multiple areas of functional and technical expertise. 
  • Proven track record with a strong knowledge of aseptic processing.
  • A minimum of 8 years in QA management managing GxP functions either in small and/or big pharma with attention to details
  • Ability to work independently on QA projects and initiatives with minimum supervision
  • Pro-active and identifying opportunities along with strong problem solving and negotiation skills.
  • Ability to work "hands on" in an entrepreneurial, fast paced environment. 
  • Leads by example and highly collaborative with the proven ability to work in a cross-functional team.
  • Self-starter and team player with strong leadership, administrative, interpersonal, and team-building skills.
  • Strong verbal, written communication skills and computer skills are required.
  • Must be goal-oriented, quality-conscientious, and customer-focused.

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

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32) Administrative Assistant 1 – Contract (New Jersey) 4183

DESCRIPTION:

  • Performs a variety of administrative, clerical and general business activities to maintain and support the efficient operation of the HR team. 
  • Must be able to work rapidly and accurately with minimal direction. 
  • Must also be able to communicate effectively with individuals from other departments, companies and countries. 
  • Strong computer skills and interpersonal skills are essential for daily work.  
  • Ensures confidential treatment of documents and sensitive information.  
  • Gathers data and prepares reports; extracting data from existing information, creating others as necessary.  
  • Provide back up assistance to other administrative staff members and managers during special projects or personnel absences

EXPERIENCE AND QUALIFICATIONS:

  • Proficient in utilizing hardware, software and web applications to perform various administrative activities and assist customers. 
  • Demonstrates proficiency in information retrieval from various HR systems.
  • Works efficiently in complex and demanding environment while maintaining a professional attitude and demeanor.
  • Manages time and logistics for customers supported including resolving conflicts, being decisive exercising sound business judgment and coordinating schedule with other internal/external executives.
  • Works with minimal supervision
  • Displays sense of urgency
  • HS Diploma.
  • 1-3 years administrative experience preferably in the HR field.

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

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33) Histology Technician – Contract (Massachusetts) 2344

DESCRIPTION:

  • Will work in a histology research group.  
  • Responsibilities will include paraffin, and frozen microtomy and basic and special histochemical staining.  
  • Must work in a team environment and help with organization and slide preparation.  
  • Assist group leaders with processing tissue and the maintenance of tissue processors.

EXPERIENCE AND QUALIFICATIONS:

  • Candidate should have experience working in a laboratory setting.  
  • Ability to comply with written protocols, documentation requirements and safety policies are essential.  
  • Basic computer skills required.  
  • Candidate should have experience working in a histology lab.    
  • BS preferred or required 2 years of experience

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

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34) Process Development Scientist – Full Time (San Francisco or Greater Bay Area) EG146H

DESCRIPTION:

  • Lead or assist with bio-chemical process optimizations to enable automation and increase throughput of diagnostic tests. 
  • Project leadership and direction.
  • Interface with both research and production teams for new product tech transfer, introduction of process improvements including increasing the throughput of existing tests.
  • Building rapport with end-users, lab supervisors and process owners, coordinate with cross functional projects teams, and lead the operation studies for process optimization and technology transfer efforts.
  • Analyze data and prepare documentation for process validations, operating procedures and reports to ensure the successful implementation of tests in the laboratory.
  • Participate in troubleshooting efforts and help drive key decisions.

EXPERIENCE AND QUALIFICATIONS:

  • Substantial experience with laboratory method and workflow optimization for scale up of molecular biology assays to enable high-throughput laboratory operations.  Must have experience as the primary person responsible for this (not only exposure or peripheral experience).
  • Proven success working individually and in within a team
  • Skilled at writing clear SOPs and Validation reports, and experience with quality management, including design control, risk analysis and mitigation strategies.
  • Hands-on scientist, experienced with adapting and validating assays for automated processes and continuous workflows.
  • Deep understanding of essential molecular biology and methods such as PCR, DNA purification, gel electrophoresis, analysis tools and instrumentation, DNA quantitation, and quality control is required. 
  • Next generation sequencing and development and support of reagents, tests, documentation, workflows or automation for CLIA laboratories a plus.
  • PhD Scientist with a minimum of 4 years of experience or Senior Research Associate with a Masters’ degree with more than 6 years of experience in molecular biology, Genetics or related field, with emphasis on Process Development and Optimization of diagnostic assays in a CLIA or FDA regulated laboratory environment. Candidates must have at least a Master's degree.
  • Relocation is open;  Must have current USA work status; 

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

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35) Medical Director – Full Time (San Francisco or Greater Bay Area) TG155B

DESCRIPTION:

  • Participate in long-range strategic planning for products in development.
  • Establish and approve scientific methods for design and implementation of clinical protocols.
  • Adverse event safety monitoring and reporting.
  • Develop study protocols in collaboration with the clinical operations department.
  • Recruit and motivate clinical investigators.
  • Presentation of technical information to internal and external personnel.
  • Contributes to Clinical Study Reports, IND Submissions and other clinical/regulatory/safety documents.
  • Manage external presentation of data (e.g. publications, scientific meetings).
  • Represent clinical research as a member of trial teams.

EXPERIENCE AND QUALIFICATIONS:

  • Experience with IND submissions and starting first in man trials preferred
  • Minimum 5 years’ experience in clinical trials is preferred, either within an academic environment or within the biopharmaceutical industry.
  • Ability to effectively participate in multi-disciplinary teams.
  • Excellent presentation skills
  • Proven organizational skills; ability to manage multiple priorities and work under pressure
  • Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials, specifically
  • Requires an M.D. or equivalent, Neurology specialty preferred and CNS clinical trial experience required

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

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36) Executive Human Resources Coordinator – Full Time (San Francisco Bay Area)

DESCRIPTION:

  • Provide advanced assistance to company executives by performing various complex administrative support functions, typically of a confidential nature. 
  • Transcribe information of a technical, confidential and/or sensitive nature
  • May be required to take meeting and/or conference call minutes. 
  • Collects and prepares information for use in discussions/meetings of executive staff and outside individuals. 
  • Maintains company electronic files
  • May collect employee timesheets and input into Payroll system for processing
  • Set up and confirm candidate interviews with clients
  • Post job advertisements
  • May find and submit qualified candidates for open positions in the client facilities/ help with recruiting. 
  • Conduct Onboarding and Outboarding of employees
  • Respond to EDD / government agency inquiries

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor’s degree strongly preferred -- BS/BA in Biology or Life Science preferred; Associate degree acceptable if  >8 years previous experience as an executive AA in the pharmaceutical or medical device industry
  • Ability to handle a large variety of details and to work with all levels of organization
  • Ability to handle sensitive confidential data
  • Excellent customer service skills and interpersonal skills 
  • Excellent oral and written communication skills
  • Self starter who quickly absorbs new information and is able to act on newly learned tasks with little supervision
  • Proficiency with use of Outlook, Microsoft Office, SharePoint and the ability to easily learn new software.    
  • Minimum of 5 years of progressive office experience as a Sr. Administrative Assistant or HR Coordinator.
  • Excellent computer skills: Applicant tracking systems; database experience, Microsoft Word, Excel, and Outlook
  • 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.

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

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37) Senior Manager (Clinical), Regulatory Affairs – Full Time (San Francisco or Greater Bay Area) FJ113N

DESCRIPTION:

  • Manages the clinical and nonclinical aspects of global regulatory affairs activities in support of late-stage product development
  • Provides leadership in the strategy and implementation of regulatory concepts within cross-functional project teams.  
  • Oversees and mentors associate-level regulatory professionals to achieve regulatory objectives in line with corporate goals.  
  • Supports corporate partners with regulatory deliverables.  
  • Continues to expand knowledge base of laws, regulations, and guidelines governing the development, licensure, and marketing of drugs and biologics.  
  • Reports to the Global Regulatory leader for assigned products.
  • Manage planning, preparation, and submission of clinical trial applications (CTAs) and marketing applications (MAs) in the US and internationally
  • Manage CTA and MA maintenance activities
  • Provide strategic regulatory insight to cross-functional project teams regarding product development
  • Serve as primary point of contact with regulatory health authorities
  • Manage and mentor multiple associate-level direct reports
  • Exercise discretion and independent judgment in the performance of the duties described above

EXPERIENCE AND QUALIFICATIONS:


  • Minimum of 3 years of experience in managing regulatory staff
  • Skilled at gathering regulatory information and developing product approval strategies
  • Proven track record of managing critical projects as a part of an interdisciplinary team
  • Proven track record of successfully interacting with regulatory health authorities
  • Prior experience managing regulatory submissions to deadlines
  • Thorough understanding of relevant drug development regulations and guidelines
  • Outstanding interpersonal and communication (written and verbal) skills
  • Effective task planning and coordination abilities
  • Minimum of 6 years of experience in US or international Regulatory Affairs in the biotechnology or pharmaceutical industry with a clinical and nonclinical emphasis
  • BS degree in life sciences required. Advanced degree preferred

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

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38) Senior Clinical Research Associate – Full Time (San Francisco or Greater Bay Area) W82LM

DESCRIPTION:

  • Manage assigned activities of clinical study to ensure it is completed on time, within budget, and in compliance with Good Clinical Practice (GCP), government regulations, and overall clinical objectives.  
  • Responsible for quality study oversight, including but not limited to monitoring, oversee clinical vendors and regional monitors, and review monitoring trip reports. 
  • Participate in the training and development of lower level CRAs. 
  • Responsible for managing more than one project.  Determine methods and procedures for performing new assignments. Provide mentorship to CTAs and CRAs.
  • Conduct monitoring and oversight of regional monitors to verify study data on source documentation and case report forms (CRFs).
  • Manage contract research organization (CRO) personnel and study sites to ensure compliance with the protocol, GCPs, FDA regulations, ICH/GCP guidelines, SOPs, and overall clinical objectives; and to ensure data discrepancies and site/CRO issues are identified and resolved in a timely manner. 
  • Manage all study parameters including, clinical study start-up activities, clinical supplies preparation, enrollment, data collection, and close-out. 
  • Participate in the development of study-related clinical documents including, but not limited to, informed consent forms, site training materials, CRFs, clinical monitoring plans, source document templates, and data audit worksheets.
  • Participate in the evaluation and selection of sites and CROs, and planning of clinical meetings (investigator meeting, and steering committee meetings.)
  • Broad knowledge of FDA and ICH regulatory requirements.
  • Assist in the preparation of study protocols, IBs, and regulatory submissions.
  • May represent clinical operations in project team meetings.
  • Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
  • Travel is required – up to 50%

EXPERIENCE AND QUALIFICATIONS:

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

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

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39) Senior Clinical Document Assistant – Full Time (San Francisco or Greater Bay Area) FH82P

DESCRIPTION:

  • Responsible for creating and maintaining accurate Trial Master Files (TMF) for all clinical studies.  
  • Duties will include but not limited to maintenance and QC of TMF, functional and orderly Clinical Document Room, and reporting TMF status to clinical operations. 
  • Responsible for the TMF inventory across multiple studies:
  • Create and maintain TMFs.
  • Receive in documents and QC TMF documents for accuracy & completeness.
  • Review the transfer information of all documents submitted to the system.
  • Accurate and consistent filling of essential documents in TMF.
  • Participate in file reconciliation and quality control checks.
  • Maintain accurate and up-to-date tracking systems, forms, logs, binders and other relevant documents to support essential document management.
  • Provide accurate and up-to-date essential document status as it relates to TMFs.
  • Collaborate and communicate closely with cross-functional teams as a TMF repository advisor.
  • Assist in the archiving of clinical study files when required.
  • Business Administrator for TMF MasterControl
  • Responsible for administering security privileges with MasterControl for Clinical staff – these privileges include managing routes, organizers, documents and controlled copies, for all TMF Infocard and SubInfocard types.
  • Create TMF InfoCard, TMF document attachment, QC and verification.
  • Responsible for Clinical employees’ training records.  Perform regular audits to ensure training files are accurate and complete.
  • Coordinate and track MasterControl training required for clinical.
  • Perform TMF based information and metrics collection as well as status updates, as requested.
  • Ensures document room is functional and orderly at all times.

EXPERIENCE AND QUALIFICATIONS:

  • A degree in life sciences or equalivant experience or previous experience working with Clinical Trial Document; TMF

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

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40) Head of Clinical Operations – Full Time or Consultant (San Diego Area) YF154W

DESCRIPTION:

  • Execute all clinical operations activities related to drug products in order to achieve the company strategies, commitments and goals with effective resource utilization. 
  • This position will report to the Chief Medical Officer.
  • Participating in the formulation of overall clinical strategy and the design of clinical studies to establish the safety, efficacy and marketability of products 
  • Assuring the timely and high quality implementation of Phase 1-4 clinical studies, including site selection, CRF design, study document preparation, study initiation, patient enrollment, site monitoring, data collection, and report writing
  • Managing the clinical department budget and clinical study agreement process
  • Developing and maintaining appropriate Standard Operating Procedures (SOPs) for the clinical department and assuring compliance
  • Assessing the need for, identifying and managing external resources including CROs, contractors, and clinical operations consultants
  • Working with medical and regulatory staff (and/or outside consultants and contractors) in the preparation of project-related documents and regulatory submissions, including Investigator’s Brochure, INDs and NDAs

EXPERIENCE AND QUALIFICATIONS:

  • Extensive experience in the design, execution and reporting of clinical studies
  • Previous experience managing CROs in both the US, Europe 
  • Working knowledge of GCP requirements
  • Working knowledge of US, Europe and international regulatory requirements
  • Strong leadership and management skills with previous experience in the supervision of clinical operations staff
  • Excellent planning, organizing, problem-solving and execution skills
  • Ability to travel – domestic and international (minimum 25%) 
  • BS degree in Life Sciences or equivalent 
  • Minimum 15 years of relevant pharmaceutical clinical research experience 

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

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41) (Senior / Associate) Director, Regulatory Affairs – Full Time (San Francisco or Greater Bay Area) J151DP

DESCRIPTION:

  • Title depends on experience level.  
  • Reports to VP Regulatory. 
  • This position currently has no direct reports but it may have staff to manage in the future.
  • Responsible for activities pertaining to submissions to, and communications with, the FDA and other health authorities and manage the activities of other regulatory affairs staff or contract regulatory support
  • Develop regulatory strategies for assigned program in collaboration with regulatory senior management and through analysis of guidance and assessment of drugs with a similar indication to support development and marketing approval objectives within specified timelines
  • In collaboration with team, perform/manage critical analyses of data (clinical, preclinical and manufacturing), independently develop interpretations and conclusions. 
  • Review of clinical protocols, clinical study reports, chemistry, manufacturing and controls documents with respect to alignment with program strategy and consistency of scientific interpretations/messages, clarity, completeness, and regulatory requirements
  • Oversee and participate in submission-related activities for NDAs
  • Lead multidisciplinary teams in the authoring of regulatory communications such as regulatory briefing packages
  • Responsible for communications with the FDA and/or other Health Authorities
  • Oversee and ensure compliance with regulatory procedures and work practices.
  • Proactively identify program issues and implement appropriate regulatory strategies to mitigate risks

EXPERIENCE AND QUALIFICATIONS:

  • Experience with pharmaceutical, non-clinical, and clinical development
  • Demonstrated experience in the preparation and submission of NDAs.
  • Expert knowledge of FDA and foreign regulations and guidelines.
  • Excellent written and verbal communication skills.
  • Minimum of 10 years of experience in regulatory affairs.
  • At least Bachelor's degree in a scientific discipline
  • Masters or Ph.D. preferred

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

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42) Director, Clinical Operations – Full Time (San Francisco or Greater Bay Area) B151GQ

DESCRIPTION:

  • Lead clinical trial teams and oversee the management of all operational aspects of clinical study conduct from selection and qualification of vendors and investigational sites through finalization of clinical study reports. 
  • Will report to the Senior Director, Clinical Operations.
  • Collaborates with cross-functional teams to design and develop clinical study protocols in line with business needs
  • Develops and manages study timelines, milestones and budgets
  • Develops study management plans and forecast study resourcing
  • Selects and leads clinical trial teams
  • Development of study protocols, case report forms, informed consent forms and other study-related documents
  • Selection, management and oversight of CROs to ensure that clinical studies are executed properly and in compliance with GCPs
  • Review and qualification of investigational sites
  • Management of clinical study monitoring
  • Collection and archival of all documents for inclusion in the Trial Master Files
  • Review and finalization of clinical study report
  • Identify quality initiatives prior to study start and manage initiatives throughout the study; implement appropriate corrective action plans.
  • Serve as primary project contact, or as escalation contact, internally, and with any CRO to ensure high level of communication and partnership is maintained and timelines are effectively met.
  • Manage the development or develop/update clinical SOPs in accordance with ICH and GCP guidelines.
  • Directly manage and mentor/develop staff to ensure high quality team results.

EXPERIENCE AND QUALIFICATIONS:

  • Strong written and verbal communication, interpersonal, problem solving and negotiation skills
  • Excellent presentation skills
  • Ability to present to diverse groups of clinical staff (internal and external) 
  • Proven organizational skills
  • Ability to manage multiple priorities and work under pressure
  • Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials, specifically, knowledge of 21 Code of Federal Regulations Title 21 Parts 11, 50, 54, 56, 312, 314; International Conference on Harmonization Guidelines E6 (Good Clinical Practice: Consolidated Guidance), E2A, E8 and Guidelines from other Regulatory Authorities pertinent to planned studies
  • Knowledge of computer software: Microsoft Word, Excel, PowerPoint, Project, and Visio
  • Ability to travel
  • Strong leadership skills to present to Senior Management 
  • At least 5 years of experience managing staff and selecting/hiring team members.
  • CNS experience is preferred and international study experience is a plus.
  • Bachelor's degree in life sciences or related field and 10 plus years of clinical management experience in a combination of pharmaceutical, biotechnology and CRO industries.

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

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43) Sr Programmer / Principal Dataset Statistical Programmer – Full Time (Boston Area) GP153F

DESCRIPTION:

  • This is a leadership role able to lead and direct project work.  
  • Create input data files for NONMEM software which is used to conduct a population PK or population PK / PD (Phamocometrics) analysis using UNIX SAS software to develop a program based on provided programming specifications.
  • Program and plan the integration of databases from multiple studies or sources.
  • Lead or assist in the application of computer science and information technology methods to provide the technical components that support all aspects of pharmacology clinical development process, including clinical development plans and scientific utilization data. 
  • Provide strategic input and leadership to the delivery of all technical programming and information components of deliverables.
  • Oversee the quality of all deliverables, holding partners and providers accountable for the quality of their deliverable
  • Lead programming support for deliverables to the regulatory submissions including delivery of NONMEM data.
  • Identify opportunities to improve the methodology and provide practical solutions for problems 
  • Contribute to the development of best practice to improve quality, efficiency and effectiveness

EXPERIENCE AND QUALIFICATIONS:

  • Knowledge of CDASH/SDTM/ADaM CDISC standards
  • Experience of Regulatory submissions preferred
  • Excellent communication and collaboration skills.  
  • Will work across global & functional boundaries 
  • Ability to apply programming expertise to problems, problem solving and quality focus
  • Agile responsiveness to scientific data
  • Other programming languages e.g. S-PLUS, R etc.
  • Computer technical background a plus (Linux, high performance cluster)
  • Data management background a plus (clean data for analysis)
  • Experience with Pharmacometrics (Pharmacokinetics PK / Pharmacodynamics PD) data a plus
  • Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials data. 
  • Ability to work effectively on multiple tasks or projects.
  • BSc in Mathematical, Statistical, Computer Science or Life Science
  • Extensive SAS programming expertise to an advanced level.  2 years generating NONMEM datasets preferred

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

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44) Medical Director Gastroenterology – Full Time (San Francisco or Greater Bay Area) FQ140K

DESCRIPTION:

  • Collaborate with the clinical development group and other departments to assure successful, high-quality drug development
  • Provide expert scientific, medical, and drug safety contributions (medical monitor, safety monitor, etc) into the design, conduct, and assessment of GI clinical studies. 
  • Reports to the Vice President clinical development.
  • Execute and supervise clinical studies, analyze results and write study reports.
  • Contribute to the clinical sections of regulatory documents and meetings.
  • Interact with regulatory agencies throughout the development process.
  • Manage the drug development process from protocol creation thorough individual study report and integrated regulatory document creation.
  • Collaborate with contributing groups such as Biostatistics, Drug Safety, Regulatory Affairs, Quality Assurance, Project Planning, and Clinical & Medical Affairs
  • Consult with key opinion leaders, as needed, to ensure drug development activities are in line with current medical knowledge and standards.
  • Collaborate with external contract service vendors, Investigators, and clinicians.
  • Serve as medical monitor, responsible for the safety monitoring of clinical trials, and as medical expert for clinical studies

EXPERIENCE AND QUALIFICATIONS:

  • Experience and expertise in creating and implementing drug development strategies resulting in efficient and successful product approvals.
  • Expertise in the regulations and guidance (CFR, ICH, GCP) governing drug development.
  • Expertise in clinical study monitoring, i.e. assessing adverse events, safety lab test results, and ECGs
  • Expertise in the clinical drug development process is required. 
  • Effective leader of clinical research staff. 
  • Exceptional interpersonal skills. 
  • Ability to create highly functional, collaborative, and successful clinical teams.
  • Expertise in assuring high-quality clinical trial conduct management, data management, and data analysis.
  • Three or more years of pharmaceutical industry drug development experience is required.
  • A MD is required
  • Must be board eligible in the US
  • A minimum of 3 years treating patients for gastrointestinal disorders is required

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

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45) Director Project Manager – Contract (10 to 15 hrs/wk long term) (San Francisco or Greater Bay Area) GB152Y

DESCRIPTION:

  • Responsible for project management of all aspects of product development for IND submissions and clinical trials
  • Manages team to execute all project deliverables; leads cross-functional core team and vendors.
  • Coordinates, synchronizes and manages overall project schedule.  
  • Accountable for execution on project timelines.
  • Identify appropriate resources needed and develop schedule to ensure timely completion of project
  • Regularly track and communicate project status to all stakeholders
  • Schedule and facilitate all necessary meetings associated with product development
  • Assess, communicate and manage risk
  • Facilitates identification and mitigation of program risks.  
  • Highlights business implications of identified risks
  • Acts as information conduit between the team, vendors, and senior management, prepares and presents reviews

EXPERIENCE AND QUALIFICATIONS:

  • Experience with IND submission
  • Experience with Phase 1 / 2 clinical trials
  • Experience with budgets, Microsoft Project timelines, and meeting minutes/ agendas
  • Works on complex, multi-faceted problems where analysis may require in depth analysis
  • Solves problems in imaginative and practical manner
  • Able to make decisions that impact project timeline, budget, strategic fit and viability to business.
  • Interacts and connects with core and extended team members most of which are consultants or contracted vendor organizations
  • Able to influence others or gain acceptance in sensitive situations
  • Minimum of Bachelor's degree (B. S.), preferred in the Life Sciences
  • 10 or more years of combined drug product development and project management experience

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

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46) Director, Regulatory Affairs – Full Time (San Francisco or Greater Bay Area) BG111P

DESCRIPTION:

  • Provide expertise in translating regulatory requirements into practical, workable plans for development stage drugs 
  • Responsible for activities pertaining to submissions to, and communications with, the FDA and other health authorities and manage the activities of other regulatory affairs staff or contract regulatory support in the performance of the duties outlined below.
  • Develop regulatory strategies for assigned program in collaboration with regulatory senior management and through analysis of guidance and assessment of drugs with a similar indication to support development and marketing approval objectives within specified timelines
  • Provide guidance to multidisciplinary teams on the regulatory requirements to support clinical development, include preparation and maintenance of IND or CTA filings. 
  • Oversee development of all regulatory filings in support of program
  • In collaboration with team, perform/manage critical analyses of data (clinical, preclinical and manufacturing), independently develop interpretations and conclusions. 
  • Review of clinical protocols, clinical study reports, chemistry, manufacturing and controls documents with respect to alignment with program strategy and consistency of scientific interpretations/messages, clarity, completeness, and regulatory requirements
  • Oversee and participate in submission-related activities for CTAs, INDs, BLAs.
  • Lead multidisciplinary teams in the authoring of regulatory communications such as regulatory briefing packages
  • Responsible for communications with the FDA and/or other Health Authorities
  • Oversee and ensure compliance with regulatory procedures and work practices.
  • Proactively identify program issues and implement appropriate regulatory strategies to mitigate risks
  • Train and mentor regulatory personnel on strategic matters, related to company and external information. 
  • Maintains a positive team spirit and leads by ethical principles.

EXPERIENCE AND QUALIFICATIONS:

  • Strategic thinker, planner, and implementer. 
  • Excellent organizational skills.
  • Experience with pharmaceutical, non-clinical, and clinical development
  • Proven ability to plan and execute complex projects, proven record of delivering results within business- defined timeframes.
  • Experience leading and coaching staff.
  • Expert knowledge of FDA and foreign regulations and guidelines.
  • Excellent written and verbal communication skills.
  • Ability to make sound decisions in complex situations
  • Demonstrated experience in the preparation and submission of INDs, BLAs, and NDAs.
  • Knowledge of GMPs, GLPs, GCPs.
  • Proficiency in MS-word, excel, PowerPoint, and Adobe.
  • At least Bachelor's degree in a scientific discipline 
  • Preferred Masters or Ph.D. 
  • Minimum of 10 years of experience in regulatory affairs.

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

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47) Sr. Product Development Test Engineer – Full Time (San Francisco or Greater Bay Area) F122KM

DESCRIPTION:

  • Responsible for the conception, design and development of medical devices through engineering analysis, prototyping, risk assessment and appropriate qualification testing
  • This position will spend ~ 35% designing (e.g. concept, sketching etc.) with ~ 15% of that time in CAD. 
  • Assist with design and engineering specifications of prototype medical devices and instruments
  • Design, fabricate and/or specify test fixturing and equipment used for device feasibility and development
  • Research design options and perform experiments to determine potential design feasibility.
  • Create solid models for product using SolidWorks
  • Create drawings, prototypes or other means to communicate the intent of the design for review
  • Participate in the development of design failure modes and effect analysis reports and Fault Tree Analysis reports
  • Interface with other engineering disciplines, both internal and external, in developing solutions
  • Perform lab tests and document the results
  • Prepare and carry out test protocols for product development
  • Interact with global and internal design and manufacturing resources to design for manufacturability, reliability and cost-effectiveness
  • Review product documentation for accuracy including documentation intended for customer use.

EXPERIENCE AND QUALIFICATIONS:

  • Concept, design and prototype development skills
  • Proficiency in CAD, preferably SolidWorks
  • Understand Design History File (DHF) content requirements
  • Possess excellent communication and technical writing skills
  • Ability to write protocols, analyze results, and summarize in a report
  • Ability to work productively and proactively with technical, multi-disciplinary product teams in a start-up environment
  • Experience with design verification test activities including test planning, test procedure and test report development
  • Familiar with FDA CFR 21 regulations (part 820) and an understanding of ISO 13485 and the EU Medical Device Directive a plus
  • 5+ years of experience with medical product development
  • Minimum of 3 years in design engineering 
  • A minimum of a Bachelor's degree in Mechanical Engineering or related science (with coursework in advanced math, statics, dynamics, and statistics)

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

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48) Executive Director, Clinical Regulatory Affairs – Full Time (San Francisco or Greater Bay Area) AP113X

DESCRIPTION:

  • 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.
  • 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. 
  • 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 with both biologics and small molecules is desirable
  • At least 8 years of experience in managing regulatory staff
  • At least 12 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industry with clinical and nonclinical emphasis
  • 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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49) CTM / Sr. Clinical Trial Manager - Oncology – Full Time (San Francisco or Greater Bay Area) JM82P

DESCRIPTION:

  • Manage and lead all aspects of one or more oncology Phase 1 to 4 clinical trials including, but not limited to protocol development to final report, clinical operations support for trial start-up, conduct, and close-out activities in order to achieve program objectives and goals.  
  • Collaborate with clinical contracts/budget to manage efforts for clinical service provider selection. 
  • Lead clinical trial project execution for oncology programs to ensure that trial timelines, costs, and quality metrics are met.
  • Serves as primary contact for functional area representatives in managing protocol execution.
  • Manage the financial aspect of clinical trials to ensure accuracy and timeliness of service provider and site payments.
  • Forecast and oversee clinical supplies
  • Manage study milestones to ensure accurate tracking and reporting of study metrics.
  • Oversee ongoing service provider management (e.g., CROs, IVRS), including independent negotiation of scope of work, budgets, performance management, and issue resolution.
  • Create and manage clinical trial budgets in collaboration with the Vice President of Clinical Operations.
  • Provide study-specific direction and mentoring to CRAs and CTAs. 
  • Collaborate with clinical QA to maintain quality standards in compliance with regulatory requirements/guidance’s and adherence to SOPs and ICH/GCPs; participate in ongoing process improvement initiatives.
  • Manage adherence to ICH/GCP/local regulations.
  • Participate in clinical operations initiatives and programs.
  • Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.


EXPERIENCE AND QUALIFICATIONS:

  • Broad and current knowledge of regulations, clinical development process and oncology.
  • 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 includes Word, Excel, PowerPoint, and Outlook.
  • Working knowledge of MS Project for development and update of clinical study timelines. 
  • Willing to travel up to 25%.
  • Bachelor’s Degree with at least 5 years of CRA experience for the manager level.  
  • Requires 8+ years of combined CRA and CTM experience.  
  • At least 2 years direct staff management experience is required.

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

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50) Manufacturing Test Engineer, Systems Engineering – Full Time (San Francisco or Greater Bay Area) LM73V

DESCRIPTION:

  • Will interact with other engineering disciplines to define, develop, document, perform, analyze and interpret manufacturing tests for various analytical instruments for the life sciences market.  
  • Develop and implement manufacturing test strategies and processes for prototype instruments and instruments released into manufacturing.
  • Perform manufacturing testing and train production personnel.
  • Analyze data, evaluate results, form conclusions and provide feedback to the improve product design.
  • Develop and implement manufacturing test fixtures for instrument or subassembly testing.
  • Create and maintain manufacturing test procedures, work instructions, SOPs, BOMs and data sheets.
  • Perform risk analysis, FMEA, and implement risk mitigation activities to support the life-cycle of the product.
  • Perform system design analysis and provide feedback to the design team for improved manufacturability and testability.
  • Work closely with design team to improve product design and function.
  • Test, troubleshoot and repair systems, instruments and processes.
  • Mentor engineers with less experience.

EXPERIENCE AND QUALIFICATIONS:

  • Demonstrated ability to scale up production activities including the transfer of manufacturing technologies to other manufacturing sites.
  • Demonstrated ability to support daily production activities.  
  • Able to troubleshoot and resolve problems with complex instrumentation, systems or processes down to the component level.
  • Able to perform root cause analysis.
  • Familiar with phase-gate product development processes.
  • Demonstrated ability to conduct data analysis
  • Must be well organized and have project management experience.
  • Must be self motivated and work exceptionally well in multi-disciplinary teams.
  • Must have excellent communication skills.
  • 5 years or more hands-on experience in developing tests for analytical instruments or other complex systems in a manufacturing environment.
  • BS or greater in sciences or engineering and 5 years experience in a manufacturing engineering environment.
  • Familiar with Six Sigma preferred

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

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51) Clinical Program Manager – Full Time or Contract to Full Time (San Francisco or Greater Bay Area) G121PA

DESCRIPTION:

  • Responsible for the daily management of Phase I-III clinical studies. 
  • Ensuring that clinical programs are executed with compliance to clinical practices and the study protocol, and that studies are developed and managed on time and within budget. 
  • May be responsible for the management of one or more clinical trials, and may act as program team leader or member while also serving as a resource to the clinical department and the company to achieve our clinical research objectives.
  • Manage the day-to-day clinical operations of the clinical trial/program
  • Participates in CRO and vendor selection process for assigned clinical programs
  • Manage CRO(s), clinical vendors, and team members throughout clinical study lifecycle
  • Oversees clinical site identification, training and initiation, monitoring, and closeout
  • Reviews and refines clinical study and vendor plans
  • Leads study data review for quality and consistency to study objectives
  • Manages study timelines, budget, and resource allocation
  • Oversees submission of trial-related documents into the trial master file
  • Maintains effective relationships with clinical collaborators and clinical site personnel
  • Collaborates with Medical, Regulatory Affairs, Quality, Research & Development, and other Clinical Research personnel
  • Analyzes information, and utilizes prior clinical experience and problem solving skills to ensure the best possible outcome of the clinical research program
  • Attends or leads cross-departmental project team meetings, which includes preparation of meeting agendas, and timely and accurate communication of team meeting decision and action items
  • Reviews and reconciles financial aspects of study (e.g., invoice and payment tracking)
  • Assists in providing cross-functional program operation plans and cost estimates
  • Provides routine updates on clinical study and/or program milestones
  • Provides clinical study and/or program status reports on a timely basis to the project team and senior management
  • Mentors staff and acts as a clinical resource for new employees
  • Position may include up to 20% domestic and/or international travel
  • Other duties as assigned

EXPERIENCE AND QUALIFICATIONS:

  • Thorough knowledge of ICH/GCP guidelines, FDA requirements for INDs, NDAs, and drug approval process
  • Excellent analytical, negotiation, and problem-solving skills
  • Outstanding organizational, communication, and presentation skills
  • Thorough understanding of cross-functional clinical processes including data management, drug safety, biostatistics, and medical writing
  • Strong influencing skills are required to manage clinical site personnel
  • Exhibited ability to be proactive and agile in a fluid clinical study environment
  • Must be candid and transparent when reporting status and alerts to the clinical team, clinical management and senior management of the company in a full-disclosure and proactive manner
  • Candidates must be experienced with a proven track record in a clinical research management, high-energy, able to function in a growing, dynamic environment and able to multi-task and communicate at all levels within the organization
  • Bachelor’s degree in a scientific field or equivalent and 7+ years of clinical experience
  • 5+ years direct experience managing clinical studies, including field monitoring experience

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

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52) Project Team Leader/ Sr Director – Full Time (San Francisco or Greater Bay Area) RY151F

DESCRIPTION:

  • The project team leader will be instrumental supporting company growth in providing expertise to manage the development drug candidates into therapeutics that can be filed, approved by regulatory agencies and successfully commercialized on a global basis. 
  • Will play a key strategic role through the lifetime of project, transitioning the drug candidate out of research into clinical development and taking it through to launch and lifecycle management.
  • Responsible and accountable for leading one or more project teams. 
  • The project team leader will ensure that optimal development strategies that align to corporate objectives and to the strategic plan for the therapeutic area are in place and executed to agreed time, quality and budget objectives. 
  • Responsible for generating a product life cycle plan to deliver maximum value throughout the life of the product.
  • This is a Senior Director position reporting to the vice president of management.
  • Lead global, cross-functional project development teams to develop strategic plans and to ensure execution of the development plans for each of the drug candidates (from concept through marketing and life cycle management).
  • Work closely with team to create innovative target product profiles and product development plans that optimize value, time, resources and risk while ensuring that project strategy is aligned with business objectives.
  • Partner with cross-functional team members, including Project Manager, Research, Clinical, Non-Clinical, Regulatory Affairs, CMC and Finance to ensure that projects have adequate resources and technical expertise to meet strategic objectives.
  • Identify issues and risks and lead contingency planning.
  • Ensure adherence of project plan and activities to agreed time, resource, budget and scope.
  • Accountable for product development documentation (integrated project plans, etc.).
  • Drive decision-making  and ensuring conflict resolution at product development level.
  • Present strategic issues, project plans, options and recommendations to senior management.
  • Communicate project information to senior management and key stakeholders.
  • Maintain commercial, scientific and regulatory awareness to ensure that project plans reflect latest scientific/medical developments and regulatory/commercial environment.

EXPERIENCE AND QUALIFICATIONS:

  • Previous experience as a project team leader is a plus. 
  • NDA experience is required; Launch experience is desired.
  • In-depth knowledge and experience of the global drug development and commercialization process.
  • Proven management and/or leadership experience in an R&D or commercial context within pharma and/or biotech and successful track record managing development projects.
  • Experience in more than one therapeutic areas preferred.
  • Strategic thinker with excellent problem solving skills and an ability to influence all levels of the company.
  • Ability to achieve results in a matrix management organization, across different sites and with colleagues of diverse functional expertise, skills and priorities. This would include the ability to challenge the status quo where relevant, and to resolve conflict within the team while maintaining clear focus on business objectives.
  • Ability to drive, anticipate, influence and implement change.
  • Ability to be effective as a team player as well as a team leader, exhibiting excellent listening and collaboration skills.
  • Excellent communication, writing, planning and tracking skills.
  • Bachelor’s degree in a scientific, medical or business discipline. 
  • An additional/post-graduate qualification is an advantage (PhD, MBA etc.); minimum of 12 years of experience in management/leadership roles in pharm and/or biotech.

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

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53) Clinical Trial Manager – Full Time (San Francisco or Greater Bay Area) GA139X

DESCRIPTION:

Seeking a highly motivated individual to join the Clinical Operations group. This individual will play a key role in assisting the 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, the ability to adapt quickly to changing business conditions, strong interpersonal and team building skills. We are 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.

Responsibilities:
  • Responsible for the successful planning and execution of clinical studies to ensure that trials are conducted on time, on budget, and in compliance will the protocol, all applicable regulations and SOPs. Uses thorough knowledge of FDA regulations and ICH guidelines to ensure compliance with both of these during clinical trial planning, conduct, and close-out; develops monitoring plans, tracking tools and other mechanisms to ensure that trial is conducted according to plan
  • Works with supervisor to lead the management team in the development of study-specific documentation, including protocols, CRFs, subject consent forms, study reference manuals, etc; may author some or some portions of these documents
  • Assists in the development of outsourcing plans for external vendors – develop and facilitate RFPs, review proposals and make award recommendations, select and manage vendors to ensure that project goals are achieved
  • Assists with the day-to-day management of CROs and sites in the conduct of one or more clinical studies; organizes and leads teleconferences with key CRO personnel, facilitates CRO activities and adherence to scope of work and service agreement
  • Establishes relationships with Investigators and other key site personnel as well as CROs and key CRO personnel; may serve as primary point of contact for US CRAs or specific CRO personnel
  • Participates in department process improvement initiatives – may review and revise SOPs, working practices and other infrastructure as directed; assist in the creation and improvement of department infrastructure to ensure that studies are conducted in compliance with GCP and CFR and that all essential documentation is collected, maintained, archived and inspection ready
  • Performs monitoring or co-monitoring of clinical sites as required by the needs of the project, and with minimal guidance from supervisor; develops and oversees study quality metrics to ensure that subject recruitment goals are met
  • Works with supervisor, external partners and sites to ensure that clinical data from a variety of sources is appropriately captured, monitored, source-verified, edit-checked, reconciled and otherwise ‘quality assured’;  provide input for the design of CRFs, monitoring conventions, edit checks, etc.
  • Assists in the development of clinical trial budgets; monitors activities at sites and vendors to ensure compliance with budget; supports efforts to revise budget forecast as needed; develops and maintains study budget tracking tools to ensure that trial costs are accurately tracked and reported to finance
  • Partners with and supports MD's and other scientific leaders to ensure that scientific objectives of the clinical studies are met; provides reports, metrics and other information for analysis and interpretation as needed; may take part in advisory meetings, investigator meetings and other study-specific scientific venues in order to support scientific objectives
  • Participates in the ongoing and final review of clinical study data and assessment of the impact of this data to the study and program. May author some sections of clinical study protocols, consent forms, manuals, study reports, annual reports and other clinical documents

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor’s degree in science or health-related field required
  • Minimum of 5-7 years of clinical trial management experience, with a minimum of 3-5 years of trial management experience in Pharmaceutical or Biotech company required; early-phase trial management preferred
  • Oncology or Immunology required.
  • Thorough and proven knowledge of GCP, CFR and ICH guidelines;  Proven track record for delivering clinical projects within time, budget and quality expectations; global clinical trials experience highly desirable
  • Strong written and oral communication skills; proficiency in MS office including Word, XL, Powerpoint and other applications; demonstrated experience in technical writing
  • Highly-motivated, accountable, and able to perform work independently with minimal supervision and with a sense of urgency;
  • Exceptional interpersonal skills, team-oriented approach, collaborative, flexible and eager to contribute in a sometimes resource-constrained setting;
  • Able to travel up to 35% 

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

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54) Engineer II, Mechanical – Full Time (San Francisco or Greater Bay Area) G73AX

DESCRIPTION:

  • Responsible for the development, test, and manufacturing transfer of various mechanical components for analytical instruments for the life sciences market. 
  • The ideal candidate would have at least 3 years experience in mechanical design of analytical instruments or medical devices.   
  • The candidate must also have demonstrated the ability to solve complex mechanical problems with innovative designs and solutions.  

EXPERIENCE AND QUALIFICATIONS:

  • A strong academic background with a minimum of a BS in mechanical engineering.
  • 3 plus years hands on experience in developing mechanical subsystems for analytical instruments or medical devices in a regulated environment.   
  • Must also have demonstrated the ability to work with manufacturing partners to scale up production activities including the transfer of manufacturing technologies to other sites (domestically and overseas).
  • Have an understanding of packaging mechanical and electronic assemblies, and be familiar with UL/CE/TUV regulations and EMI reduction.  
  • Should also be familiar with ISO 14385 or have design regulation experience.
  • Be versed in various metal fabrication techniques including casting, sheet metal fabrication, as well traditional machining methods. 
  • Be also versed in manufacturing such as injection molding and molding as well as 3D printing.
  • Demonstrated strong user in a 3-D CAD package such as ProE Wildfire (preferred) or SolidWorks.  This includes taking conceptual industrial designs and developing them into manufacturable parts.
  • Familiar with a PLM software such as Agile or SAP.
  • Have ability to create manufacturing drawings and documentation with practical knowledge of general drafting practices and Geometric Dimensioning and Tolerancing per ASME/ANSI standards. 
  • An understanding of DFMEA/DFM/DFS, Design for Six Sigma (DFSS) principles.
  • Be able to resolve complex design challenges with imaginative solutions. 
  • Be a team player with the ability to work with people across disciplines to define and develop innovative products.
  • Have good mechanical aptitude and trouble-shooting skills, creative thinking and a positive attitude.
  • At least 3 years experience in the mechanical design of analytical instruments or medical devices for the life sciences including the transfer of manufacturing to domestic and overseas manufacturing partners.
  • Project planning and cost forecasting
  • Experienced in advanced modeling techniques for stress analysis (FEA) or thermal (CFD).

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

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55) Staff Engineer, Mechanical – Full Time (San Francisco or Greater Bay Area) LZ73H

DESCRIPTION:

  • Responsible for the development, layout, and manufacturing transfer of various analytical instruments or medical devices for the life sciences market. 
  • The ideal candidate would have at least 8 years’ experience in the mechanical chassis design of the instrument or medical devices and as well as in the design of plastic enclosures for the instrument / device.   
  • Must also have demonstrated the ability to oversee successful product launches from “cradle to grave” including overseeing the transfer to domestic and overseas manufacturing partners.

EXPERIENCE AND QUALIFICATIONS:


  • Well versed in various metal fabrication techniques including casting, sheet metal fabrication, as well traditional machining methods. 
  • Well versed in manufacturing such as plasctic injection molding and RIM molding as well as 3D printing.
  • Must have demonstrated the ability to work with manufacturing partners to scale up production activities including the transfer of manufacturing technologies to other sites (domestically and overseas).
  • Have a strong understanding of packaging mechanical and electronic assemblies, and be familiar with UL/CE/TUV regulations and EMI reduction.  Should also be familiar with ISO 14385 or have design regulation experience.
  • Demonstrated strong user in a 3-D CAD package such as ProE Wildfire (preferred) or SolidWorks.  This includes taking conceptual industrial designs and developing them into manufacturable parts.
  • Experience in a PLM software such as Agile or SAP a plus.
  • Have ability to create manufacturing drawings and documentation with practical knowledge of general drafting practices and Geometric Dimensioning and Tolerancing per ASME/ANSI standards. 
  • A strong knowledge of DFMEA/DFM/DFS, Design for Six Sigma (DFSS)
  • Be able to support day to day production activities.  
  • Troubleshoot and resolve complex processing or equipment issues down to the component level as needed.  Perform root cause analysis.
  • Be capable of improving production yields, lowering costs and improving safety by identifying and implementing new equipment/technologies, safety systems and other techniques such as Statistical Process Controls (SPC).
  • Have project management / team interaction experience.  Capable of working closely with Facilities, Finance, and Employee Health & Safety to plan, implement, and qualify new equipment and to minimize time from delivery to production. 
  • Understand how to lay out components inside of the instrument during the development process
  • A team player with the ability to work with team members across disciplines plus project management experience.
  • 5 or more years hands on experience in developing mechanical subsystems for analytical instruments as well as development of chassis (sheet metal work) and enclosures for the instruments or experience in developing medical devices with a minimum of 100 parts in a regulated environment. 
  • Minimum of BS in mechanical engineering with a strong academic background 

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

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56) Associate Director / Director of Quality Assurance – Full Time or Consultant (San Francisco or Greater Bay Area) P150WB

DESCRIPTION:

  • Maintain and establish documented company-wide quality system in full compliance with ISO 13485 and FDA QSR
  • Manage the QA, quality engineering, and document control functions. 
  • Direct interactions with FDA, notified state department of health related to company inspections. 
  • Hire, train, and manage quality engineers, quality technicians/inspectors and document control personnel. 
  • Provide directly, or through subordinates, active quality engineering participation on project team during the development process.
  • Establish and direct the employee QSR and ISO training program. 
  • Establish and oversee environmental controls program. 
  • Provide support and guidance to sterilization validation, biocompatibility programs. 
  • With manufacturing management, establish and oversee supplier audits. 
  • Establish and direct completion of regularly scheduled internal audits. 
  • Review and approve all product labeling and marketing materials to ensure compliance with regulatory requirements.
  • Ensure that accurate and complete records of company-wide activities are generated, properly secured, and that they meet regulatory requirements.
  • Serve as designated management representative for the company during management review, regularly present to quality senior staff on related issues. 
  • Manage vigilance/medical device reporting and complaint management activities. 
  • Initiate and chair Complaint Review Committee as required. 
  • Develop, implement and supervise the non-conformance (NCR) and CAPA systems. 
  • Initiate and chair material review board (MRB) as required. 
  • Ensure calibration system for all inspection, production and R&D instruments is established and maintained. 
  • Provide quality system awareness training to employees as required. 
  • Proactively develop and support company goals and objectives, policies and procedures, GMP and FDA, and MOD
  • Maintain a professional, credible image with consultants, suppliers, and co-workers. 
  • Perform other duties as assigned.

EXPERIENCE AND QUALIFICATIONS:

  • ASQC Certificate in quality engineering or quality management. 
  • Minimum of seven years related experience, preferably in the medical device field
  • At least 3 years management/supervisory experience. 
  • Good interpersonal, supervisory and training skills. 
  • Ability to work independently and resolve issues. 
  • Computer literacy in Word, Excel, and PowerPoint required. 
  • Comprehensive knowledge of and intimate familiarity with the requirements of current versions of ISO 13485 and FDA QSR
  • BSME (or related discipline).

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

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57) Test Engineer III – Full Time (San Francisco or Greater Bay Area) KW73B

DESCRIPTION:

  • Will interact with other engineering disciplines to define, develop, document, perform, analyze and interpret manufacturing tests for various analytical instruments for the life sciences market. 
  • Develop and implement manufacturing test strategies and processes for prototype instruments and instruments released into manufacturing.
  • Perform manufacturing testing and train production personnel.
  • Analyze data, evaluate results, form conclusions and provide feedback to the improve product design.
  • Develop and implement manufacturing test fixtures for instrument or subassembly testing.
  • Create and maintain manufacturing test procedures, work instructions, SOPs, BOMs and data sheets.
  • Perform risk analysis, FMEA, and implement risk mitigation activities to support the life-cycle of the product.
  • Perform system design analysis and provide feedback to the design team for improved manufacturability and testability.
  • Work closely with design team to improve product design and function.
  • Test, troubleshoot and repair systems, instruments and processes.
  • Mentor engineers with less experience.

EXPERIENCE AND QUALIFICATIONS:

  • Demonstrated ability to scale up production activities including the transfer of manufacturing technologies to other manufacturing sites.
  • Familiar with Six Sigma
  • Demonstrated ability to support daily production activities. 
  • Able to troubleshoot and resolve problems with complex instrumentation, systems or processes down to the component level.
  • Able to perform root cause analysis.
  • Familiar with phase-gate product development processes.
  • Demonstrated ability to conduct data analysis
  • Must be well organized and have project management experience.
  • Must be self motivated and work exceptionally well in multi-disciplinary teams.
  • Must have excellent communication skills.
  • 5 years or more hands-on experience in developing tests for analytical instruments or other complex systems in a manufacturing environment.
  • BS or greater in sciences or engineering and 5 years experience in a manufacturing engineering environment.

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

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58) Senior Director – Project Team Leader – Full Time (San Francisco or Greater Bay Area) A139JX

DESCRIPTION:

Reporting to the CMO, the Project Team Leader (PTL) will be responsible for leading development of therapeutics from pre-IND to Phase III. The PTL will provide direction and leadership to the cross-functional project team including scientific oversight of activities, budget and planning; and partner with stakeholders to develop project vision, strategy, scope, milestones, risk assessment, valuation and project investment requirements. Typical project teams include representation from research, nonclinical & clinical clinical pharmacology, regulatory affairs, commercial, finance and CMC. Utilize deep understanding of drug development and commercialization to effectively lead teams and to drive strategic decisions. 

Responsibilities

  • Plan and execute product development projects. 
  • Plan and direct schedules and monitors budget/spending. 
  • Ensures consistent practices throughout all phases of the project life cycle. 
  • Drives the development and manages the execution of high quality, integrated cross-functional plans for projects. 
  • Applies project management best practices in the development, initiation, planning, execution, control and closing of projects. 
  • Provides clear direction on product development requirements to meet expectations of external customers and business stakeholders. 
  • Interacts with research and development, marketing, manufacturing, and regulatory departments and with external stakeholders. 
  • Responsible for project performance, risk management, administration, financial management and issue resolution for functional group. 
  • Selects, develops and evaluates personnel to ensure the efficient operation of the function.

EXPERIENCE AND QUALIFICATIONS:


  • Experience leading teams in a matrix environment and demonstrated skills in motivation of teams is required. 
  • Candidate must possess a strong ability to cultivate excellent cross-functional collaborations.
  • Strong decision-making and analytical skills are required.
  • Excellent communication and influencing skills with a proven ability to work with executive management are critical to the success of the role.
  • Will be a dynamic and innovative leader with a well-developed sense of teamwork and have the interpersonal skills required to communicate effectively with external collaborators and internal stakeholders. 
  • The individual will also be a well-respected mentor through coaching, respect, honesty, humanity and daily practice of lead-by-example. 
  • Successful colleagues can manage successfully, and can develop and execute project plans within a busy environment.
  • At least 10 years of industry experience in drug development, including experience in early phase non-clinical and clinical drug development and regulatory knowledge
  • The successful candidate will ideally have an advanced degree in life sciences or medicine (MD or PhD) and/or an MBA.  

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

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59) Clinical Program Manager – Full Time (San Francisco or Greater Bay Area) G149PR

DESCRIPTION:

  • Provide leadership to a multi-functional study team in order to ensure that assigned clinical trials are executed on time, on budget, and in compliance with GCP and other applicable guidelines and regulations. 
  • Contribute to the development of clinical operations department processes and procedures and may also be responsible for hiring, development and performance management of direct reports.  
  • Directs a multi-functional study team in the day-to-day execution of clinical trials
  • Partners with clinical operations management and project management to define study milestones and deliverables and executes to ensure timelines, budget and quality are met.
  • Actively participates in CRO, site and vendor selection in order to ensure that trial responsibilities are appropriately delegated and that partners are aligned with corporate objectives; provides ongoing surveillance of progress and ensures that contingency plans are triggered as and where appropriate
  • Provides mentorship, supervision and training to other staff assigned to the study, which may include direct and indirect reports and contract monitors.
  • In collaboration with the medical monitor and other personnel, may lead the planning and execution of successful investigator meetings.
  • Works to resolve day-to-day issues in the timely on boarding and initiation of clinical sites, and challenges in the efficient enrollment of study subjects; monitors and reports on the progress of site initiation and subject recruitment.
  • Supervises site monitoring, reviews monitoring reports and metrics, and participates in site auditing to ensure that these tasks are performed reliably and in compliance with applicable regulations
  • Ensures that the study team is up-to-date on current program status and priorities and ensures the goals/objectives are aligned with the corporate goals
  • Develops and refines monitoring plans as well as lab and pharmacy manuals, training manuals, and other procedural manuals as needed to ensure that the trial is conducted consistently across countries and sites.
  • Oversees biometrics vendors, partners with external service providers to develop data management plans, edit check specifications, and analysis specifications
  • Develops expertise and understanding specific to the assigned therapeutic area(s) and builds upon information from previous trials to better the conduct of current and future studies; ensures that program-wide structure and long-term implications are taken into consideration when operational decisions are made (for example design,databases and coding dictionaries) – pro-actively works with supervisor to anticipate long-term implications of such decisions.
  • Provides regular status reports and metric updates of studies to senior management and to project management; works with other personnel to identify risks within studies and proactively plans mitigation strategies
  • Participates in internal/external audits of vendors/sites; works pro-actively to identify compliance risks and partners with team members to trigger preventive or corrective actions where appropriate
  • Works closely with the medical monitor regarding safety reporting and interacts with CRO personnel to ensure timely and accurate delivery of data for safety monitoring committees.
  • Leads departmental or interdepartmental infrastructure and process improvement initiatives where assigned; partners effectively with supervisor to build and continually improve department infrastructure.
  • Assists with the writing of clinical protocols, investigator brochures and annual IND reports where required; reviews and contributes content to these documents to ensure their accurate description of trial status and study subject events.
  • May travel 

EXPERIENCE AND QUALIFICATIONS:

  • Bachelor’s degree in a scientific field and 7+ years of clinical trial experience, including at least 4 years of independent trial management experience in a sponsor company
  • Must have independent site monitoring and management experience, and demonstrated track record of increasing levels of responsibility in complex clinical trial management
  • Direct supervisory experience with multiple direct reports strongly preferred
  • Broad knowledge of clinical drug development processes, industry standards, GCPs, clinical trials monitoring, regulatory compliance and an understanding of clinical data management and statistical reporting
  • Thorough knowledge of ICH/GCP guidelines as well as 21 CFR and other applicable regulations.
  • Proven organizational skills with ability to manage multiple urgent priorities in parallel
  • Established leadership and influence skills – able to adapt to different environments and circumstances and to influence and effectively motivate internal and external team members.
  • Excellent analytical, negotiation and problem-solving skills
  • Flexible, adaptable, and able to react to changing circumstances and priorities
  • Outstanding interpersonal and communication skills – able to articulate complex issues effectively in person, and in writing; diplomatic when interacting with multiple internal and external customers.
  • Displays a high level of commitment and professionalism in all environments; leads by example

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

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60) Statistical Programmer Manager / Associate Director – Full Time (San Francisco or Greater Bay Area) MG140P

DESCRIPTION:

Serves as a lead programmer for assigned clinical study projects and is held accountable for all expected deliverables. Responsible for the development, validation, execution, maintenance, documentation, and archival of analysis datasets and programming code used in the analysis of clinical trial data targeted for regulatory submission. All programming must be consistent with good programming practice and compliant with regulatory requirements. Work interactively with biostatistics, data management, clinical and regulatory personnel and other departments as appropriate. Interact with outside groups, e.g., Data Management CROs and EDC vendors.

Responsibilities:
  • Act as a lead programmer for assigned projects/studies
  • Reports to Director Statistical Programming
  • Understand and be accountable for project deliverables
  • Attend project study team meetings
  • Review CRF, data management plan, statistical analysis plan, and other documents as appropriate (e.g. data transfer specifications with vendors)
  • Review and provide feedback on data provided by vendors
  • Develop analysis file specification
  • Assign tasks to other programmers
  • Track programming status, including verification status
  • In accordance with departmental objectives, use and share prior experiences in solving complex problems in creative and effective ways.
  • Plan, design, develop, implement, validate, and maintain software for the monitoring, reporting, and analysis of clinical trial data in accordance with department SOPs.
  • Collaborate with statistician and assist in the development of the statistical analysis plan (SAP).
  • Help develop and review case report forms and assist in the review of the clinical trial database system, structure, and validation.
  • Develop project specific and departmental standardized programming tools and routines for analysis.
  • Facilitate communication with and provide guidance to CROs/external vendors (data management CROs) to achieve defined objectives.

EXPERIENCE AND QUALIFICATIONS:

  • Strong communication skills
  • Ability to articulately communicate complex information to others and to comprehend complex analysis issues. Being visible and approachable.
  • Ability to communicate verbally and in writing in a clear and timely manner; ability to listen to and understand the clinical study team and statistical programming department are required.
  • Ability to effectively express concepts and points of view in individual and informal group situations.
  • Ability to present ideas in an organized and concise manner.
  • Strong problem-solving skill including debugging code, looking up reference materials and documentation, and contacting appropriate support.  Must be able to exercise sound judgment within departmental practices in selecting methods and techniques to solve problems.
  • At least 7 years of experience in clinical application development (using SAS) in the pharmaceutical/biotech industry.
  • Experience in the preparation and/or defense of regulatory submissions is required.
  • Proficiency with SAS/BASE, SAS/STAT, SAS macros, SAS/GRAPH, PROC SQL, and PROC REPORT.
  • Must be familiar with basic statistical concepts, such as: linear regression analysis, analysis of variance, hypothesis testing, non-parametric analysis, categorical data analysis, confidence intervals, p-values and capable of implementing these ideas in clear, concise SAS code for the purposes of data analysis and reporting.
  • An understanding of clinical trial principles and regulatory requirements, including a basic knowledge of FDA/ICH guidelines and the software development life cycle; experience dealing with FDA/regulatory requests.
  • Strong familiarity with CDISC data structure including SDTM and ADaM.
  • Must be flexible and able to work both independently and as part of a team within a dynamic, interdisciplinary.
  • Ability to prioritize and handle multiple tasks simultaneously is a must.
  • Strong documentation skills. 
  • Bachelor’s degree, preferably in statistics, math, computer science, or similar discipline is required. A Masters degree in statistics is strongly recommended.       

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

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61) Manager, Regulatory Affairs – Full Time (San Francisco or Greater Bay Area) WB148M

DESCRIPTION:

Working in a team environment, responsible for the development and coordination of regulatory submissions, prepared under the direction of senior regulatory guidance and per applicable FDA and/or ICH requirements. This hands-on position requires management of all technical and operation aspects related to regulatory lifecycle (e.g., from preclinical through registration) of assigned programs/projects. It requires cross-functional interactions with internal departments, contractors, CROs and vendors, and external partners.

Responsibilities
  • Represent department on multidisciplinary product development teams and to senior management, as required
  • Participate in the development and implementation of regulatory strategy, including development of product development plan(s) and target product profile, for one or more programs
  • Prepare, coordinate, manage or maintain simple and complex regulatory submissions (e.g., INDs, CTAs, amendments, safety reports, DSUR, annual reports, meeting packages) in accordance with applicable regulations; this includes ability to translate regulatory requirements into practical, workable submission plans; develop & maintain timelines; coordinate internal/external authoring/review/comment adjudication and finalization (submission and archival)
  • Interface with external regulatory groups (e.g., CRO, partner, consultants) in the preparation/review/compilation/finalization/submission/posting of regulatory submissions
  • Promote, prepare, and implement standard regulatory submission content templates
  • Review and communicate current & emerging regulatory requirements (e.g., US and international regulations and guidelines) in quality, preclinical, and clinical areas for development programs in harmony with the QA/compliance group
  • Author and review standard operating procedures (SOPs); ensure SOPs are in compliance with current regulatory requirements
  • Provide thoughtful & accurate comments during document (e.g., IB, protocol, ICFs, DSURs, Annual Reports) review, mindful of regulatory/ICH guidance/requirements pertaining to document content
  • Monitor company progress toward fulfillment of regulatory commitments
  • Initiate and/or contribute to local process improvements which have an impact on the regulatory affairs, QA or other departments

EXPERIENCE AND QUALIFICATIONS:


  • Hands-on experience in preparation, submission and management of investigational applications
  • Strong knowledge of regulatory requirements (FDA, ICH) as well as GXP/ICH guidelines and regulations
  • Strong written and verbal communication, problem solving, and human relation skills in addition to high analytical skills (i.e., ability to understand technical details)
  • Proven ability to interact effectively across multiple functional groups and projects
  • Excellent project management skills with ability to prioritize and handle projects concurrently
  • Self-directed, focused, flexible, and detail-oriented
  • Computer proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook) and Adobe.
  • Preferred but not required: Advanced degree, experience with CMC Regulatory, NDA experience, eCTD, oncology, Interfacing with regulatory authorities, and regulatory affairs certification
  • Bachelor’s degree (BA or BS) in scientific discipline or equivalent
  • Minimum 5 years pharmaceutical industry experience
  • Minimum 4 years of relevant experience in regulatory affairs with focus in development of drugs/biologics

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

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62) Associate Director, Clinical Operations – Full Time (San Francisco or Greater Bay Area) Z148PG

DESCRIPTION:

  • Lead the coordination and execution of clinical trial management activities across multiple studies.
  • Manage designated vendors and consultants.
  • Supervise assigned staff and complete annual goal-setting meetings and performance appraisal meetings.
  • Coordinate the training of clinical staff on assigned clinical development studies; provide direction and support to clinical operations team.
  • Participate in clinical study design teams, development of clinical research protocols.
  • Evaluate the feasibility and of appropriate scientific and clinical strategies for clinical development studies.
  • Ensure team compliance with clinical operations policies and procedures.
  • Evaluate processes to identify areas for further efficiency and streamlining.
  • Assist in creation of risk mitigation strategies, associated action plan and issue resolution.
  • Govern vendor performance and develop successful working relationships with vendors.
  • Liaise with outsourcing manager to create vendor metrics and track these metrics through the course of all assigned studies.
  • Oversee budget creation and collaborate cross-functionally to track actual spend against projections.
  • Track clinical ops project milestones using appropriate tools.
  • Assist in preparation of interim analysis, database closure, and clinical study report activities as necessary.
  • Present study status updates at executive team meetings as needed.
  • Collaborate with Sr. Director Clinical Operations to assess clinical operations resourcing needs.

EXPERIENCE AND QUALIFICATIONS:

  • Proven leadership skill set managing Phase I-IV clinical trials in the pharmaceutical or CRO setting.
  • CRO-management experience on large global trials with proven success.
  • Experience in directing activities associated with multi-center, multi-national clinical trials.
  • Exceptional time management, organizational and communication skills (both verbal and written).
  • Strong people management skill set, which includes promoting the professional and personal growth of subordinates.
  • The ability to apply principles of logical or scientific thinking to define problems, collect data, establish facts and draw valid conclusions.
  • Effective presentation skills to deliver speeches and/or presentations as necessary.
  • Proven success in ability to deliver high quality results within aggressive timelines.
  • Oncology background desirable.
  • Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials.
  • Some knowledge of project management processes and tools.
  • Fluent in written and spoken English.
  • Computer literate with proficiency in Microsoft Office suite and Outlook.
  • Bachelor's Degree in medicine, science or equivalent degree/experience.
  • A progression of clinical trial management experience with previous leadership and/or management activities demonstrated.

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

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63) Regional Pharmaceutical Sales Representative – Full Time (San Francisco, Boston, Wash D.C., Philadelphia, Raleigh/Durham) YA147T

DESCRIPTION:

  • The Sales Representative will be responsible for managing his/her assigned territory and marketing/promoting to current and new pharmaceutical companies.   
  • The representative will be given 5 to 8 large current pharmaceutical clients with the objective to increase penetration of sales to these clients.  
  • In addition, the Sales Representative will be expected to generate new business.

EXPERIENCE AND QUALIFICATIONS:

  • A clean driver’s record, must be able to drive in the assigned region for client meetings
  • Experience growing territories
  • Must be highly motivated and have excellent presentation skills
  • 2-5 years of outside business to business sales experience in the biotech, medical device, medical diagnostics, or bioinformatics industries
  • Bachelor’s / Master’s degree in Biology or other Life Sciences preferred.  Other Science degrees will be considered.

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

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64) Manager / Sr. Manager, Regulatory Affairs – Full Time (San Francisco or Greater Bay Area) AG132D

DESCRIPTION:

  • Actively contribute in the development and implementation of regulatory activities for product development and approval.
  • Responsible for specific regulatory documents, submission, and compliance issues.  
  • Provide regulatory support to departments, project teams, and committees in managing the development of products. 
  • Manage the day-to-day regulatory affairs activities for specific projects and related domestic and international applications (INDs, MFs, IMPDs, CTXs, ODs, etc.), and prepare for the filing of subsequent licensing applications (NDA, MAA, e-CTD, etc.).  
  • Coordinate multiple submissions and projects effectively
  • Execute, independently or with very limited guidance and supervision, product development and regulatory strategies regarding submissions and/or compliance issues
  • Assess and exercise good, independent judgment in interpretation and implementation of governmental regulations and procedures, including developing and authoring internal procedures and company SOPs
  • Maintain/manage, coordinate, and review submissions for existing and new products
  • Manage interdepartmental regulatory matters and provide regulatory guidance to internal personnel (e.g., executive committee; project teams; clinical, preclinical, and manufacturing departments and subcommittees)
  • Direct interaction with regulatory agencies on defined matters.  
  • Build and maintain excellent relationships with FDA personnel and representatives from corporate partners
  • Foster teamwork and improve intra-/inter-departmental communications
  • Collaborate with external parties, partner companies and investigator-sponsors, on regulatory strategy for IND and NDA filings
  • Supervise regulatory staff and guide associates in carrying out responsibilities.  Coordinate associates’ activities and career development
  • Position will regularly interact with all departments and all levels within a department
  • Position may have direct reports


EXPERIENCE AND QUALIFICATIONS:

  • Ability to work either independently with minimal direction separately or within project teams, committees to attain group goals
  • Ability to creatively complete activities within the allotted, sometimes aggressive, time schedules
  • Invest additional time, as required, to expedite or complete assignments or projects
  • Able to prioritize work and to complete assignments with minimal guidance
  • Thorough working knowledge and understanding (application of knowledge/experience) of FDA regulations, especially for drug therapeutics
  • Ability to learn and assimilate scientific information
  • Must have experience managing global clinical studies (phase 3 a plus) and interacting directly with CROs.  
  • Oversee, review and approve CTA filings in conjunction with CRO and study team
  • Experience and knowledge in the preparation of INDs, NDAs, MFs, BLAs, CTA or MAAs and all supportive amendments or supplements
  • Previous experience in interpretation of Health Authority regulations, guidelines, and policy statements
  • Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff
  • Knowledge of GMPs, GLPs, and GCPs
  • Well organized, detail oriented, effective written and oral communication skills, and good grammatical skills
  • Ability to guide, train, and supervise personnel
  • Computer literate
  • Previous experience in managing interactions with FDA and other regulatory authorities preferred
  • Prefer previous regulatory/technical management experience.
  • Minimum three to five years pharmaceutical/biotechnology industry experience, with relevant regulatory experience
  • B.S. degree in sciences, preferably advanced degree in life sciences

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

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65) Senior HFM Analyst – Contract (Southern California)

DESCRIPTION:

  • Perform HFM (Hyperion Financial Management )/FDM technical development and QA functions.
  • Using Financial Data Quality Manager (FDQM) and HFM consolidation, validation and execution.
  • Ensures that plans for system technologies integrate effectively with multiple application and enterprise layers of hardware and software.
  • Experience with Hyperion (9.x and higher 11.1.1.X) in the areas of design, development, deployment, and database administration.
  • Centrally managed and collaborated financial information and processes with HFM.        
  • Translate high-level business requirements into detailed functional specifications
  • Lead all testing activities and resources prior to UAT ensuring quality and requirements are met ensure compliance to system architecture, methods, standards, practices and participate in their creation.
  • Updating HFM dimensions and metadata 

EXPERIENCE AND QUALIFICATIONS:

  • Ideally a background in finance or accounting or supporting accounting consolidations
  • Project management experience
  • Oracle-Hyperion EPM 11 Suites including (Hyperion Workspace, Shared Services, Hyperion Financial management, Interactive Reports, Web Analysis, etc), Hyperion Essbase OLAP Server, Analyzer, Pivot Table, Hyperion Performance Suite , Hyperion Financial Management, and Oracle SOA          
  • Bachelor's Degree in finance, accounting or information systems.

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

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66) R & D Scientist (Senior Scientist) – Full Time (San Francisco or Greater Bay Area) W146KQ

DESCRIPTION:

  • The successful candidate will be a self-starter, enjoy working in a fast-paced multidisciplinary team environment, and be motivated to develop technologies with a significant clinical impact.
  • Leading in-lab efforts to develop novel nucleic acid based tests, including planning, feasibility testing, protocol development, optimization, verification and validation, and launch
  • Designing and coordinating the execution of effective experiments and analyzing data
  • Making experimental decisions to meet timelines
  • Documenting research progress under a quality management system
  • Communicating progress directly with colleagues and senior management

EXPERIENCE AND QUALIFICATIONS:

  • Track record of originating new methodologies and developing novel nucleic acid techniques.
  • Experience with nucleic acid technology relating to PCR, qPCR, multiplex PCR, and digital PCR.
  • Experience with next generation sequencing.
  • Demonstrated success in applying independent scientific judgment in experimental design and analysis.
  • Proven success in managing collaborative and individual projects, skills at writing clear SOPs and reports, and experience with Design Control a plus.
  • Strong analytical and problem solving skills.
  • Adept with Excel, basic statistical analysis.
  • Programming (e.g. PERL, python) and databases experience (SQL) a plus.
  • Strongly prefer Ph.D. in molecular biology or closely a related field and at least 4 years of industry experience.

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

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67) Director of Technology Transfer – Full Time (San Francisco or Greater Bay Area) YP146B

DESCRIPTION:

  • Looking for a highly motivated person with excellent communication skills and a scientific background to manage relationships and partnerships with research and clinical partners 
  • Position will report to the Vice President of Research & Development
  • Work closely with R&D as well as business development to create and maintain a comprehensive plan for technology transfer, implementation, and support. 
  • Able to create and deliver technical presentations; create service and support plans; write laboratory manuals, IFUs, and workflow documents.
  • Demonstrate the highest level of professionalism while managing and maintaining partner relationships.
  • Deliver the highest level of responsiveness for partner communications, logistics, training, trouble-shooting, and ongoing technical support.
  • Ability and desire to work within a quality system that is compliant with FDA and European medical device regulations.

EXPERIENCE AND QUALIFICATIONS:

  • Proven effectiveness in communicating with individuals across various corporate functions including sales, business development, and research and development.
  • Able to travel 5-10% of the time.
  • Demonstrable success in developing and implementing plans and managing projects
  • Experience with development activities such as trouble-shooting, optimization, verification, and validation.
  • Knowledge of various regulations such as CLIA, CAP, 21CFR 820, 806, 803, 210, 211, European In-Vitro Diagnostic Directive 98/79/EC, EN ISO 13485:2012 preferred.
  • Knowledge of DNA sequencing, qPCR, PCR, and related methods preferred.
  • PhD or MS in molecular biology or related field and at least 4 years of hands on experience in molecular diagnostic assay research, development, and deployment.

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

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68) Regional CRA – Full Time (Western US) DM104Z

DESCRIPTION:

  • The primary responsibility of the Regional CRA Consultant is to provide site management, information management, and monitoring of clinical research studies
  • Responsibilities may include site monitoring, review of regulatory documents, accurate and timely documentation and communication, oversight of safety reporting, development and maintenance of study documents and study supplies, and management of outside vendors.
  • Travel up to 65% may be required.

EXPERIENCE AND QUALIFICATIONS:

  • Candidates must have an RN or 4-year college degree, preferably in a biomedical or science related field, and at least 3-5 years experience as a Clinical Research Associate
  • 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, flexibility with changing priorities, effective communication and personal skills necessary for successful teamwork.
  • At least 3-5 years of prior experience as a Clinical Research Associate, including monitoring experience. More experience may be required for specific assignments.
  • Must have availability of a car in good condition, a valid driver's license, a good driving record, and car insurance. Ability to travel, including air travel, on notice as short as 24 hours, maintaining efficient and effective travel schedules.
  • Worked on Cardiovascular Clinical studies

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

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69) Regional CRA – Full Time (Central US) G104ZA

DESCRIPTION:

  • The primary responsibility of the Regional CRA Consultant is to provide site management, information management, and monitoring of clinical research studies
  • Responsibilities may include site monitoring, review of regulatory documents, accurate and timely documentation and communication, oversight of safety reporting, development and maintenance of study documents and study supplies, and management of outside vendors.
  • Travel up to 65% may be required.

EXPERIENCE AND QUALIFICATIONS:

  • Candidates must have an RN or 4-year college degree, preferably in a biomedical or science related field, and at least 3-5 years experience as a Clinical Research Associate
  • 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, flexibility with changing priorities, effective communication and personal skills necessary for successful teamwork.
  • At least 3-5 years of prior experience as a Clinical Research Associate, including monitoring experience. More experience may be required for specific assignments.
  • Must have availability of a car in good condition, a valid driver's license, a good driving record, and car insurance. Ability to travel, including air travel, on notice as short as 24 hours, maintaining efficient and effective travel schedules.
  • Worked on Cardiovascular Clinical studies

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

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70) Regional CRA – Full Time (Northeastern US) BY104K

DESCRIPTION:

  • The primary responsibility of the Regional CRA Consultant is to provide site management, information management, and monitoring of clinical research studies
  • Responsibilities may include site monitoring, review of regulatory documents, accurate and timely documentation and communication, oversight of safety reporting, development and maintenance of study documents and study supplies, and management of outside vendors.
  • Travel up to 65% may be required.

EXPERIENCE AND QUALIFICATIONS:

  • Candidates must have an RN or 4-year college degree, preferably in a biomedical or science related field, and at least 3-5 years experience as a Clinical Research Associate
  • 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, flexibility with changing priorities, effective communication and personal skills necessary for successful teamwork.
  • At least 3-5 years of prior experience as a Clinical Research Associate, including monitoring experience. More experience may be required for specific assignments.
  • Must have availability of a car in good condition, a valid driver's license, a good driving record, and car insurance. Ability to travel, including air travel, on notice as short as 24 hours, maintaining efficient and effective travel schedules.
  • Worked on Cardiovascular and/or Ophthalmology clinical Studies.

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

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71) Senior Global Project Manager – Full Time (San Francisco or Greater Bay Area) B100FQ

DESCRIPTION:


As a key member on project teams the project manager is expected to be knowledgeable about the overall program in order to be strategic in planning, team management, and process management. This is achieved by delivering high quality project management support and other high value services to enable team and project success.

Responsibilities:
  • Applying project management expertise, methodologies, & department standards
  • Communicating effectively with team members, senior leaders, and the broader organization
  • Leveraging well developed interpersonal skills to build & maintain positive working relationships with customers and key stakeholders
  • Contributing to functional excellence and business improvement initiatives
  • Using project knowledge to be strategic in planning short-, mid-, long-term project  plans and  identifying interdependencies
  • Developing, maintaining, tracking, and managing a high-quality, integrated project plan to enable accurate reporting and decision making
  • Managing the critical path of the project and key project risks
  • Using strong project and organizational knowledge, leadership and active facilitation to enable effective team meetings and high performance teams
  • Managing team-level and corporate processes effectively, using strong project and process knowledge, to drive team deliverables

EXPERIENCE AND QUALIFICATIONS:

  • Demonstrated ability to think strategically when planning, managing teams, and managing processes
  • Strong project management to enable precise execution
  • Skillful use of interpersonal skills and influence to accomplish work without formal authority and to ensure optimal team performance
  • Excellent communication and customer service skills, which enable successful collaboration with executive level stakeholders internally and externally
  • Strong experience facilitating project team meetings, cross-functional communication and decision making, and ensuring alignment with internal and external stakeholders
  • Sound judgment, problem solving, leadership, and collaboration in selecting methods and techniques for obtaining solutions to problems.
  • Proven leadership skills, executive presence, maturity, emotional intelligence
  • Ability to work effectively with cross-functional teams
  • Ability to work in a highly matrixed organization with non-co located teams
  • Ability to travel internationally
  • 10 years of pharmaceutical/biotech industry experience and a minimum of 3 years of Project Management experience supporting cross-functional drug development teams (clinical, clinical operations, regulatory, CMC, device, diagnostics, or Phase I-IV) is required. Pharma/biotech drug development experience is preferred.
  • Bachelor’s Degree required. Scientific degree preferred. 
  • Advanced degree (Science, MBA, PM) preferred.

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

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72) Manufacturing Technician – Contract (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) T145JA

DESCRIPTION:

  • Responsible for assembly and manufacturing of product throughout all stages of development, including research and development, preclinical testing, clinical evaluation, and commercial release.
  • Performs incoming receiving and inspection duties and product testing as needed. 
  • Supports manufacturing development, including qualification of equipment, fixtures, processes, and any required testing.
  • Supports manufacturing/operations through tracking of inventory and providing or recording data for trend analysis.
  • Essential responsibilities and duties include, but are not limited to the following:
  • Follows work instructions for building sub-assemblies, components, and finished goods.
  • May include some off-site travel to contract manufacturer facilities.
  • Performs testing per written protocols or test methods.
  • Records test data and communicates data/results to manufacturing and operations department.
  • Performs incoming receiving duties, including inspection and disposition of product and subsequent delivery to inventory, quarantine
  • Performs or supports equipment, process, or component qualification studies per written protocols.
  • Performs preventive maintenance and calibration activities for all relevant equipment, where applicable.
  • Communicates manufacturing problems, inefficiencies, bottlenecks, etc. and possible avenues for improvement to manufacturing/operations department.
  • Communicates any product problems, defects, failures, etc. that currently exist or that may reasonably come to exist at a future time.
  • Supports the keeping of product inventory, including organization, labeling, and quantification.
  • Supports troubleshooting activities. 
  • Support the Manufacturing Manager in meeting the department objectives.
  • Maintains Design History Records as required by the Design Control procedures.
  • Ensures that all changes to specifications and procedures are documented in compliance with FDA and ISO regulatory guidelines.
  • Performs tasks according to GDP (Good Documentation Practices) and GMPs (Good Manufacturing Practices)

EXPERIENCE AND QUALIFICATIONS:

  • High school degree. 
  • Diploma preferred. 
  • Experience as a Manufacturing Technician in a medical device environment (+3 years). 
  • Excellent dexterity for working with small parts under a microscope. 
  • Experience in a GMP and GDP environment. 
  • Great attention to detail and concentration for ensuring quality product.
  • Ability to read and closely adhere to written work instructions, protocols, test methods, etc. and to 
  • carefully document all test results, manufacturing activities, etc.
  • Excellent communication skills to provide feedback to department team members. 
  • Experience in the design control and documentation requirements of FDA and ISO for Class II and III 
  • medical devices.
  • The ability to work independently. 
  • Excellent organization skills and be detail-oriented.
  • Excellent interpersonal skills and a spirit of teamwork.

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

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73) Cost Analysis 1 – Contract (Massachusetts) 8205

DESCRIPTION:

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

EXPERIENCE AND QUALIFICATIONS:

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

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

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74) Biostatistics Sr Manager / Associate Director/ Director – Full Time (San Francisco or Greater Bay Area) J140FB

DESCRIPTION:

Description:

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

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

EXPERIENCE AND QUALIFICATIONS:

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

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

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75) Manufacturing Associate 1 – Contract (Massachusetts) 6644

DESCRIPTION:

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

EXPERIENCE AND QUALIFICATIONS:

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

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

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76) Manufacturing Specialist III – Contract (Massachusetts) 9544

DESCRIPTION:

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

EXPERIENCE AND QUALIFICATIONS:

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

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

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

DESCRIPTION:

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

EXPERIENCE AND QUALIFICATIONS:

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

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

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

DESCRIPTION:

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

EXPERIENCE AND QUALIFICATIONS:

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

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

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79) Associate Director, Clinical Regulatory – Full Time (San Francisco or Greater Bay Area) A113KZ

DESCRIPTION:


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

EXPERIENCE AND QUALIFICATIONS:

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

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

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80) (Senior) CMC Project Manager – Full Time (San Francisco or Greater Bay Area) YP127G

DESCRIPTION:

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

EXPERIENCE AND QUALIFICATIONS:

  • A minimum of a Bachelor’s degree in a scientific discipline is required.
  • A minimum of 3 years project management experience in the Pharmaceutical industry with a strong emphasis on CMC and Quality. CMC Project Management title preferred. 
  • A minimum of 5 years in the pharmaceutical industry
  • Prior experience in managing interdisciplinary or cross functional teams is required.
  • Understanding of FDA regulatory processes and prior experience with regulatory filings is highly desired.
  • A working knowledge of basic financial accounting is required.
  • Strong working knowledge of MS Word, Excel, and PowerPoint and Project is required.
  • Must be able to demonstrate analytical and problem solving capabilities.
  • Excellent oral and written communication skills are required
  • Must be able to demonstrate strong organizational skills.

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

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81) Publication Planning Lead (Associate Director Medical Communications) – Full Time (San Francisco or Greater Bay Area) A132FJ

DESCRIPTION:

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

EXPERIENCE AND QUALIFICATIONS:

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

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

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

DESCRIPTION:

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


EXPERIENCE AND QUALIFICATIONS:

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

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

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83) Associate Director/ Director CMC – Full Time (San Francisco or Greater Bay Area) 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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84) 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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85) 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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86) 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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87) 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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88) 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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89) 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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90) 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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91) 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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92) 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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93) 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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94) 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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95) Clinical Trial Manager – Full Time (San Francisco or Greater Bay Area) 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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96) 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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97) Engineering Technician – Contract (San Francisco Bay Area) 73H9179

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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98) 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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99) 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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100) 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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101) 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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102) 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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103) Sr QC Stability Associate / Manager – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) BL122T

DESCRIPTION:

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

EXPERIENCE AND QUALIFICATIONS:

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

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

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104) 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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105) 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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106) 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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107) Biotech Recruiter / Sourcing Specialist – Full Time or Part Time (San Francisco Bay Area)

DESCRIPTION:

  • We have openings for several recruiters and are therefore flexible in terms of the work arrangement. These positions are remote (work from home office). We are open to anywhere in the USA but prefer candidates in the San Francisco Bay area.
  • Primary responsibilities are to source open positions with qualified candidates
  • Document/track recruiting activities in candidate tracking system.
  • Source, screen and interview candidates to determine fit for open positions
  • May handle specific client accounts and interact with clients if experience warrants this

EXPERIENCE AND QUALIFICATIONS:

  • MUST have minimum of 2 years of solid recruiting experience
  • Experience with Pharma, Biotech, Diagnostics or Medical Device companies is REQUIRED
  • Prior experience and absolute comfort with making cold calls
  • Must be self-motivated, present well and be able to develop relationships with candidates
  • 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
  • Must have established home office situation; Prefer those who have previously worked remotely
  • Bachelor degree is REQUIRED
  • Must live in the United States and have U.S. work status

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

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108) Associate Director / Sr. Manager Clinical Supply Chain – Full Time (San Francisco/Peninsula/South Bay/East Bay/Marin Area) JQ111V

DESCRIPTION:

Ensures that all clinical trials have timely and adequate supply for administration to subjects. The Clinical Supply Chain group is involved in a clinical trial from the early stages of inception to study closure. The AD role includes demand forecasting, determination of an appropriate presentation to the clinical site and subject, setting production schedules, inventory management at depots and sites, order management and proof of delivery, and return or destruction. Additionally the manager implements and ensures group compliance to procedures for the production and distribution of investigation product. Mentor junior colleagues in the team when needed.

Responsibilities:
  • Interpretation of a protocol or study overview to calculate total demand and translation of total demand into a demand forecast over time managing clinical labeling including label design and manufacturing        
  • Preparation of a supply plan to support the demand forecast, including determination of supply overage amounts
  • Importing and exporting clinical trial material.
  • Manage clinical packaging/distribution including negotiating contracts, designing clinical supply plans and developing the distribution 
  • Setting up Integrated Voice and Web Response Systems with the clinical team.
  • Interfacing between the CMC and clinical teams.

EXPERIENCE AND QUALIFICATIONS:

  • Experience with clinical blinding practices.
  • Experience setting up Integrated Voice and Web Response Systems.
  • Working knowledge of drug development process (Phase I-IV).
  • Working knowledge of cGMPs.
  • Experience with clinical labeling, packaging and distribution including cold chain, importing and exporting
  • Strong analytical and problem solving skills.
  • Ability to handle multiple projects simultaneously.
  • Proven project management skills.
  • Team player with demonstrated strong interpersonal skills and ability to build effective working relationships throughout all levels of the organization.        
  • Use of Microsoft Office including Word, Excel, PowerPoint, Visio and Microsoft Project.
  • BS/BA degree.
  • Minimum 3 - 9+ years industry experience in clinical operations or supply chain management. 

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

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109) 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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110) Clinical Research Associate/ SCRA, Clinical Trial Manager – Full Time (San Francisco/Marin/Sonoma/Napa/Santa Rosa/Petaluma) B127HY

DESCRIPTION:

  • Assists with the implementation and conduct of clinical studies, focusing on the areas of protocol development, study planning, site monitoring and/or monitoring management, enrollment, data quality and study reporting. The work for this position takes place in an office and not a lab. 1-2 years’ experience as a CRA required.
  • May lead small operational study teams, i.e. act as sponsor-CRO liaison or Lead CRA for a particular study.
  • Prepares study documents for assigned studies, e.g. consent and assent templates, site reference materials, site monitoring plan, pharmacy manual. Prepares materials for study startup or training, e.g. investigator meetings, vendor kickoff meetings, site initiation visits.
  • Responsible for communications relating to assigned studies; generates and distributes meeting agendas, minutes and status reports.
  • Manages Trial Master File (TMF) and Clinical Trial Management System (CTMS); responsible for reconciliation of the TMF when transferred from an external vendor.
  • Participates in the review of clinical documents (i.e. protocols, amendments, clinical study reports) and clinical sections of regulatory submissions (i.e. IND annual reports, IND and NDA filings) for consistency and quality.
  • Participates in the identification and qualification of clinical investigators, and assists with the development of site budgets. May administer site payments.
  • Participates in the assessment and selection of vendors and their ongoing performance, i.e. tracking of contracted costs and milestones.
  • May conduct site monitoring visits, independently or as a co-monitor, and complete associated visit reports and follow-up documentation. Conducts remote monitoring, via an electronic Case Report Form (eCRF) database.
  • Assists with inspection-readiness activities for FDA or other regulatory agency, preparing either internal or external teams (i.e. investigational sites).
  • Other duties as assigned.

EXPERIENCE AND QUALIFICATIONS:

  • Understanding of the study phases and general knowledge of how they apply to drug development. 
  • Bachelor’s degree in a biological science is preferred. 
  • Requires a minimum of 1-2 years’ experience as a CRA for CRA title, CRAII, SCRA, Clinical Trial Manager title requires experience to back that title and compensation level up.  Job responsibilities can be adjusted to experience level. 
  • Previous experience in pharmaceutical industry required. 
  • Strong communication skills and ability to liaise with multiple regional and external colleagues is necessary. 
  • Must be able and willing to travel on a periodic basis.
  • Local Candidates only

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

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111) Clinical Research Associate / Senior Clinical Research Associate – Full Time (San Francisco or Greater Bay Area) D129LT

DESCRIPTION:


  • Identify, select, and monitor investigational sites for clinical studies; prepare accurate and timely visit reports from all site interaction visits; review and finalize visit reports 
  • 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 follow-up with study leadership to determine appropriate action 
  • Investigate queries, monitor discrepancies 
  • Manage investigational product (IP) accountability and reconciliation process 
  • Responsible for review of IP release packages 
  • Support the payments for investigative sites, if applicable 
  • Contribute to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents 
  • Clinical data review of data listings and summary tables, including query generation 
  • 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 manager or CRO as appropriate 
  • 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:

  • Sponsor experience preferable 
  • Cardiovascular and/or late-stage study experience preferable 
  • Previous experience working with an electronic data capture system and CTMS system required 
  • Proficient with MS Word, Excel, Project 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 
  • Work experience in the pharmaceutical industry and working knowledge of GCP/ICH guidelines and the clinical development process. 
  • Advanced MS Excel skills a plus 
  • BS/RN degree or equivalent party assistance for this search. 

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

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112) 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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113) 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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114) 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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115) 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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116) 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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117) Associate Director/Director, Epidemiology – Full Time (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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118) 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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119) Sr. Product Manager – Full Time Position (San Francisco Bay Area) P73AG

DESCRIPTION:

Detailed Description

Develop and manage portfolio of software products and services that provide value added growth for the business segment. 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
 
Responsibilities:
  • 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. 
  • 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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120) 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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121) 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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122) 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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123) Manager / Sr. Manager, Regulatory Affairs – Full Time (San Francisco/Peninsula/Sonoma/Napa/Santa Rosa/Petaluma) PN94G

DESCRIPTION:

  • Responsible for implementing regulatory strategy and managing operational activities for assigned projects.
  • Provides input into global regulatory strategy.
  • Manages planning and preparation of major regulatory submissions, e.g. INDs, NDAs/BLAs, annual reports, orphan drug applications.
  • Coordinates and prepares responses to health authority questions.
  • Interacts verbally and in written fashion with regulatory agencies under the general direction of the department director.
  • Serves as regulatory representative on various subteams, e.g. study team.
  • Interacts with consulting groups working on various regulatory projects.
  • Periodically performs reviews/audits of internal systems to ensure ongoing compliance with SOPs and regulations.  
  • Participates in multidisciplinary team audits.
  • Maintains ongoing review of regulatory publications.  
  • Keeps necessary personnel apprised of changes in regulatory policies of practices for domestic and international regulations.
  • Performs regulatory intelligence searches for registration and other regulatory requirements as applicable.
  • Trains regulatory and clinical personnel on regulatory guidelines and internal procedures for submission to regulatory agencies.
  • Under the general direction of the department director oversees work assignment of Regulatory Coordinator.

EXPERIENCE AND QUALIFICATIONS:

  • Excellent communication skills, both oral and written.
  • In-depth knowledge of FDA regulations and ICH guidelines and general understanding of the regulatory environment.
  • Interpersonal skills and flexibility needed to work with, and in the confidence of, a diverse set of team members from different disciplines.
  • Ability to multitask and work under tight deadlines; excellent organizational skills.
  • Proficiency with standard software programs (MS Word, Adobe Acrobat, etc.).
  • Fluent in written and spoken English.
  • BA/BS in Life Sciences or related field.
  • 5 years minimum regulatory affairs experience in the pharmaceutical/biotechnology or medical device industry with appropriate management experience.
  • 7 years in the pharmaceutical/biotechnology or medical device industry to include experience in R&D, clinical and/or quality.
  • Experience preparing, managing and submitting regulatory submissions required.
  • Experience with NDA/BLA submissions highly desirable.

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

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124) 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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125) 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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126) 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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127) 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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128) 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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129) 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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130) 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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131) 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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132) 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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133) 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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134) 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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135) 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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136) 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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137) 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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138) Recruiting Assistant – Part Time Position (San Francisco Bay Area Preferred)

DESCRIPTION:

This is an entry level work from home position with flexible hours that may range from 15 to 30+ hours per week, depending on workload.   This work can be completed during any shift (day, evening, night), but occasionally specific hours may be required.   In this role you will be responsible for searching information from job databases such as LinkedIn and then entering that information along with the LinkedIn PDF or attached resume into an Applicant Tracking System.  This position helps the technical recruiting process and you will work with multiple recruiters who are searching for particular skills for open positions.  You will use a search criteria provided by each recruiter for a particular job.  You will search for candidates who match the criteria for the job specifications. 

Essential Job Functions:
  • Receive search instructions from various recruiters
  • Perform timely and accurate searches in LinkedIn or other databases according to instructions provided
  • Deciding on profile ‘fit’ according to criteria provided
  • Entering those profiles who fit the criteria into a database, completing various fields within the database according to procedure
  • Attach the LinkedIn PDF or resume into the database
  • Emailing list of profiles entered to the recruiter(s)

EXPERIENCE AND QUALIFICATIONS:

  • Excellent knowledge of internet and LinkedIn Professional Networking database
  • Must be able to understand the various search fields on LinkedIn (by skill, company, location, connection, etc.)
  • Fast and accurate typing/data entry skills
  • Attention to detail, including accurate spelling
  • Thoroughness, decision making, independence, and analyzing information
  • Positive attitude and eagerness, and adaptability
  • Proficiency with MS Office products, email and general computer skills. 
  • MS Excel proficiency a plus
  • Must have your own home computer with high speed internet service
  • Excellent written and verbal communication skills, including a high command of the English language
  • Bachelor’s degree preferred

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

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139) 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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140) 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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141) 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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142) 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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143) 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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144) 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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145) 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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146) Sr Human Resources Coordinator/ Associate / Manager – Full Time (San Francisco Bay area)

DESCRIPTION:

  • Onboarding/ Outboarding staff and maintenance of employee records
  • May run payroll using the vendor payroll system
  • Responsible for worker's compensation audits and responses / maintenance of files to State Employment development offices
  • Registration and maintenance or business in states outside of California
  • May set up and confirm candidate interviews with clients
  • May post job advertisements
  • Stay in contact and maintain relationships with contract workers at clients
  • Identify and screen qualified candidates for open positions in the client facilities (~40% of the time is spent on recruiting)
  • Other tasks as needed

EXPERIENCE AND QUALIFICATIONS:

  • Excellent computer skills: Applicant tracking systems; database experience, Microsoft Word, Excel, Outlook
  • Ability to maintain a high level of confidentiality
  • Bachelor’s degree required -- BS/BA in Biology or Life Science preferred.
  • 2 to 5 years in  a Human Resources function; Preferably in the pharmaceutical, biotech, or medical device industry
  • Experience in a fast paced start-up environment
  • 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.
  • Must have exceptional interpersonal skills 
  • Excellent organizational skills and the ability to work independently are extremely important.
  • Must live in California

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

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

DESCRIPTION:

  • Drive, coordinate, and facilitate overall Talent Acquisition processes.
  • Manage special projects as necessary to ensure consistency for business practices
  • Schedule interviews (in person, phone, videoconference) and may gather feedback from candidate
  • Help with recruiting and sourcing efforts for specific jobs
  • May perform other related duties as required and/or assigned.

EXPERIENCE AND QUALIFICATIONS:

  • Interacts with all levels of personnel in and outside of the company.
  • Excellent written and oral communication skills.
  • Ability to interface with varying personal styles in an effective way.
  • Good judgment, tact and diplomacy with internal and external customers.
  • Ability to handle confidential and proprietary information.
  • Must possess self-motivation, enthusiasm, and a positive demeanor toward the job, the company and their work team.
  • Effectiveness in this role requires a functional knowledge of corporate operations and product line.
  • The job encounters recurring work situations with occasional variations from the norm, involving a moderate degree of complexity.
  • Accuracy is required in performing all functions of this position. 
  • Initiative and organization skills are extremely valuable to ensure a smooth office operation. 
  • The incumbent normally receives no instruction on routine work, general instruction on new assignments.
  • Excellent computer skills
  • Recent graduate with a bachelors degree in Science or Human Resources preferred

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

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