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Extensive experience in late phase drug product development and commercial development with CMC regulatory filings for US (NDA), Europe (MAA), Japan, and China. Lead and/or support activities for pharmaceutical profiling, phase-appropriate formulation development, and drug product manufacturing of the new chemical entities of RevMed during preclinical assessment and throughout clinical development phases.
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Per the integrated CMC strategy, the candidate will represent Process Development in support of regulatory filing, clinical manufacturing, raw materials and logistics, and interface with ClinOps for drug product administration conditions.
$200,000 - $275,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Lead the efforts to assess / identify potential suppliers for analytical development and QC activities in support of drug substance and drug product development and manufacturing with adequate risk assessment.
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The Senior Scientist, Formulation Development will assume the critical role of overseeing and executing investigations while developing and deploying strategies aimed at resolving a range of product-related challenges, extending from the initial stages to the more advanced phases of drug product development.
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Prior experience working on the drug product development of AAV products is keyPrior experience working in an industrial process development and/or device and formulation development environment.
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D. in Toxicology, Pharmacology, Pathology, Biochemistry or Biology with extensive pharmaceutical industry experience in drug development toxicology. Partners with and provides subject matter expertise to key internal functions (regulatory, Quality, Clinical, CMC and formulations, Product Quality, Drug safety, Medical affairs) and their external contractors or collaborators.
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Review documents associated with drug substance and product development and manufacturing, including but not limited to change controls, methods, monographs, protocols, and reports, and organize and archive documents in Veeva Quality Docs System.
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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.
$205,700 - $266,200Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Collaborate closely with other departments, including Formulation and Process Development, Manufacturing, Quality Assurance, Regulatory Affairs, and Supply Chain, to ensure seamless integration of packaging processes with overall drug product manufacturing and distribution operations.
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10 years or more of experience in pharmaceutical clinical drug development in industry including protocol development; study initiation and follow-up; IRB/EC submissions and interactions; review of clinical study data listings; review and/or preparation of clinical study reports.
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Supports the regional regulatory team to negotiate with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of product and labeling changes.
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Evaluate and develop the most appropriate biochemical and biophysical characterization tools to support biological drug product development, including adjuvanted vaccine drug products.
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The Formulation & Process Development group located at the Foster City, CA Gilead headquarters is seeking a Senior Research Scientist II to provide scientific, technical and hands-on support of drug discovery and product development related to small molecules.
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Collaborate with cross-functional departments (including Research, Pharmacology, DMPK, Translational Medicine & Clinical Pharmacology, CMC, Regulatory Affairs, Patient Safety and Pharmacovigilance) to implement discovery & development of toxicology strategies to enable the progression of optimized drug candidates and ensure that toxicological considerations are integrated into all stages of product development.
$225,000 - $260,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days 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.
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product development drug jobs in San Carlos, CA
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