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Deep knowledge and experience of working in a leadership role in the manufacture of vaccine drug substance and/or drug product is required. Minimum of 15 years experience in biopharmaceutical/ vaccine manufacturing, preferably the majority spent in science and technical role.
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Job DescriptionThe Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Responsibilities:Independently manage development projects of any type, including those that require experience with drug/vaccine/biologics development, the PMO processes and procedures related to development teams due to their significant importance to the company or complexity.
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Ability to quickly gain an understanding of the overall drug/vaccine development process and key functions involved. Advanced scientific degree (e.g., MS, PharmD, Ph. D.) preferred. Ability to quickly gain an understanding of the overall drug/vaccine development process and key functions involved.
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R&D CMC Regulatory Affairs Biologics & Vaccine Products Scientist/ Sr. Scientist page is loaded. R&D CMC Regulatory Affairs Biologics & Vaccine Products Scientist/ Sr. Scientist. As a staff member of CMC Regulatory Affairs Department of Japan Development Division, a person in charge who is willing to contribute in CMC Regulatory Affairs (RA) tasks from initial stage of new drug development to NDA filing and the approval, addition of dosage form, and change controls.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Experience at CMC labs or pilot facility of Drug Substances/Drug Products, or Analyses, or CMC Regulatory Affairs. Experience at CMC labs or pilot facility of Drug Substances/Drug Products, or Analyses, or CMC Regulatory Affairs.
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Utilize discovery, real world evidence, clinical trial and published data, and publicly available information and tools to provide economic and integrated models to answer key questions in all phases of drug and vaccine development – Phase I through loss of data exclusivity.
Full-timeExpandApply NowActive JobUpdated 25 days ago - UpvoteDownvoteShare Job
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This position supports statistical programming activities for late stage drug/vaccine clinical development projects. US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables.
Full-timeExpandUpdated 19 days ago - UpvoteDownvoteShare Job
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Interact with cross functional scientists including, Statistics, Clinical, Regulatory, QP2, CSRM, Data Management and Statistical Programming to plan for the statistical analysis and reporting of clinical drug and vaccine projects.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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This position supports statistical programming activities for multiple and/or late stage drug/vaccine clinical development projects. US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables.
$135,500 - $213,400 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Independently manage development projects of any type, including those which require experience with drug / vaccine / biologics development, the Client organization and Client processes and procedures related to development teams due to their significant importance to the company or complexity.
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The ultimate goal of these close outs is to consolidate and optimize the GPAM drug development portfolio which will enable support of new technical development projects. Expertise in early and late phase development/ drug development.
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Significant product development experience, preferably in the pharmaceutical/ biotech industry. Project Management certification / training (PMP) and / or coursework & training in Project Management preferred.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Bms.com/working-with-usAssociate Director, Drug Development Project Manager – Early Assets - OncologyEarly Development Project Managers (ED PMs) provide execution leadership for an asset or a portfolio of assets for a Therapeutic Area (TA)/Thematic Research Center (TRC.
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