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Extensive experience in late-phase drug product development and commercial development with CMC regulatory filings for the US (NDA), Europe (MAA), Japan, and China. Lead drug product development activities to advance new chemical entities (NCE) from the preclinical lead optimization stage through commercialization.
$108 - $118 an hourFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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This role requires collaboration with the Development, Quality, Regulatory, Analytical, Supply Chain, and Product & Portfolio Strategy organizations within PDM to ensure successful technology transfer, commercialization, launch, routine supply, and proactive management of changes across the product lifecycle.
$115,260 - $149,160 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Interact cross functionally and work closely with teams include stem cell biologists, chemists, structural biologists, software engineering, clinical, laboratory operations, research, and product development.
$150ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Forms cross-functional alliances with Small Molecule Drug Substance Development, Small Molecule Drug Product Development, CMC Regulatory Affairs, Quality Control and Manufacturing Operations by providing SMEs to these functions and project teams.
$221,170 - $286,220 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Director of Formulation & Drug Product Development. The responsibilities will be primarily to develop analytical methods and biophysical characterization assays, perform routine testing in support of formulation development and work with CRO/CMO for Drug Product analytical method tech transfer.
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Candidates with B.S./M.S. may also be considered with demonstrated leadership track record in analytical development and drug product process development. ● Define analytical testing strategies of raw materials, biological starting materials, in-process samples, impurity quantitation, and drug product release and stability, including selection and development of fit-for-purpose methods.
$200ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Analytical Development Lead (Director/Sr. Director level) is responsible for the AD activities for testing methods for in-process and final release product characterization of early and late-stage cell therapy programs.
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The VP of Drug Safety and Pharmacovigilance will provide the leadership and management for the infrastructure of the Drug Safety and Pharmacovigilance department across both clinical development and commercial products for the company.
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The Senior Director, Assay Development leads product technology development activities including IVD development, automation of NGS protocols, and in-house reagent manufacturing.
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The Product Management for Lab operations software / Lab information management system (LIMS) will be responsible for one or more components of Natera’s Laboratory Management Software product strategy and development to support laboratory operations of Natera’s tests.
Full-timeExpandApply NowActive JobUpdated 28 days ago - UpvoteDownvoteShare Job
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This role of Senior Research Associate for the Analytical Development (AD) position will be responsible for the execution of routine testing, including but not limited to flow cytometry assays used to characterize or release engineered CAR-T cell drug products.
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Implement and configure Enovia modules according to business needs, including but not limited to Product Data Management (PDM), Change Management, and Engineering BOM Management.
$140,000 - $170,000 a yearExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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This position has primary responsibilities for setting strategy across the clinical development program, oversight of strategic study design, study start up, CRO and vendor management, clinical data and safety monitoring, analysis and reporting of studies.
$225,000 - $275,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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In this position, you will work closely with the Process Development, Quality Control, Analytical Operations, Quality Assurance, Translational Medicine, Biometrics, and Regulatory team members and will contribute to flow cytometry-based assay development for product understanding of CARGO Therapeutics' pipeline candidates, method transfer and/or qualification, SOP/technical report authoring and review, method life cycle management, data analysis, and execution of routine analytical testing.
$100,000 - $138,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Experience planning and executing biomarker and diagnostic strategy, experimentation and testing in support of drug discovery and development, including analysis and interpretation of biomarker data in preclinical and clinical setting.
$205,700 - $266,200 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago
product development management drug jobs Title: development director Company: Omeros in Belmont, CA
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