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Lead early and late-stage drug product development activities including scale-up, design of experiments (DOEs), risk assessments, and development of the integrated control strategy in partnership with other CMC functional areas, Quality, Regulatory Affairs, and Manufacturing.
$200,000 a yearFull-timeExpandApply NowActive JobUpdated 25 days ago - UpvoteDownvoteShare Job
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Reporting to the SVP, Product Strategy & Commercialization, the Vice President, Global Program Team Leader (PTL) will be responsible for leading the cross-functional strategy team for one or more development candidates.
$339,000 a yearFull-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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The Associate Director of Radiopharmaceutical Process Development will be executing the CMC development plan and IND enabling activities, leading to the clinical manufacturing of the Drug Product.
$185,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Responsibilities -Develop assays for GMP release of gene therapy products-Develop assays for product characterization of gene therapy products-Develop assays for AAV/protein/DNA to assist in evaluation of process change, formulation andstability study-Report project status (development plans, timelines, and results) to supervisor and technical teams.
$36.11 - $40.54 an hourExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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We are seeking a highly motivated, attentive, and self-driven candidate to join our team, Biologics Pre-Pivotal Formulation and Process Development, as a Senior Research Associate I. Once onboarded, the successful candidate will contribute in developing formulation and drug product processes for innovative molecules to support toxicology and early clinical stage studies.
$120,120 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Main duties:Work cross functionally within CPT to ensure the clinical strategy is translated into the development of the study concept document, study protocol and related documentsProvide clinical/scientific input into design & implementation of clinical trial(s), their delivery, clinical data review and data cleaning, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product ( clinical input to NDA/BLA.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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6+ years (with MD or PharmD) in pharmacovigilance, drug development or applicable role in the pharmaceutical industry with significant knowledge of relevant regulatory requirements and substantial knowledge of drug safety including previous experience in a leadership role in the pharmaceutical industry.
$355,410Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Provide quality expertise and compliance oversight for GMP suppliers such as Contract Development Manufacturing Organizations (CDMOs) and Contract Research Organizations (CROs) for the delivery of company products including bulk drug substance, bulk drug product and finished goods.
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Organize regulatory submissions to health authorities (HAs), including Investigational New Drug (IND)/Clinical Trial Applications (CTAs) IND/CTA amendments, Non-Disclosure Agreements (NDA)/Marketing Authorization Applications (MAA), Orphan Drug Application, Breakthrough Applications, safety reports, pre-meeting packages, & NDA post-approval submissions.
$208,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This role requires intimate collaboration at the Team Leadership level 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 from launch to sunset/divestiture.
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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.
$118 an hourFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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In this role, you will lead and coordinate Packaging Process Validation, Packaging and Device Components Qualifications, upcoming Commercial Support, Process Monitoring, Deviations/CAPA’s and Close Collaboration with Drug Product Manufacturing and Combination Products Development team.
$240,000 a yearFull-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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The Drug Product (DP) Commercialization lead develops and facilities DP manufacturing (formulation, fill/finish and container closure) and DP analytical (tech transfer and lifecycle) strategy, program prioritization, and execution to drive the successful launch of products.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Provide support for discovery research, discovery process chemistry, and analytical development, formulation, identification of process impurities, drug substance and product degradants, and characterization of other unknown molecules.
$239,200 a yearFull-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Requires a minimal of 5+ years in genomics, synthetic biology, or drug development. This individual will be responsible for driving product and application-based messaging across Twist’s business units, including core initiatives toward cancer research, drug discovery, and human genetics.
$170,000 a yearFull-timeExpandApply NowActive JobUpdated 22 days ago
product development drug jobs in San Mateo, CA
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