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Broad understanding of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation and drug product technologies, distribution across multiple regions.
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They will apply scientific training and clinical research experience to support all aspects of drug development, from facilitating the transition of molecules from pre-clinical discovery through the achievement of clinical proof of concept and to supporting the registration and commercialization of a product.
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The Global Development Scientist Director and counterpart Global Development Medical Director work collaboratively in the clinical aspects underpinning a product. 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.
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Experience with regulations or product development in gene therapy, such as CAR-Ts, AAVs, or CRISPR technology etc. Experience in filing regulatory submissions from early development to pre and post approval submissions and product lifecycle management in the area of Cell Therapy.
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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.
$274,635 - $355,410Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Collate manufacturing process data to develop metrics, control charts and reports to improve manufacturing processesAssist with Supply Chain, Analytical, and Stability activities as neededReview/approve documents associated with Drug Product development and manufacturing, such as change controls, manufacturing batch records, protocols, investigations/deviations, and reports, and organize and archive documents in Veeva Quality Docs System.
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Adverum is looking for an Associate Director / Director, Head of Drug Product Process Development (Drug Product PD) to join the Technology Development team at our Redwood City, CA office.
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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 1 month ago - UpvoteDownvoteShare Job
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Strong knowledge of key pharmaceutical functions throughout all stages of product development, including Marketing (e.g., Market Research, Market Access), HEOR, Medical Affairs, Preclinical, Clinical, Regulatory, CMC (e.g. supply chain, drug delivery), etc.
$261,000 - $319,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This role will be responsible for the development, management, and execution of the GCP QA programs to ensure that all aspects of the drug development process are in accordance with all relevant current FDA and international regulatory guidelines as they pertain to CTI product candidates.
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Insitro is seeking a Senior Director / VP of Product Management to lead a team of Product Managers that drive the development of our lab and data platforms which enable our drug discovery work at insitro.
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We are seeking an experienced and highly motivated Director/Senior Director, Drug Product/Formulation Development who will report to the VP of CMC. This individual will drive the drug product development and strategy including pre-formulation, formulation, scale-up and manufacture for all our preclinical and clinical projects.
$241,366 - $341,670 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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For the Biologics Drug Product R&D Director position, we are seeking a highly motivated, experienced leader to lead a diverse team of pharmaceutical development scientists supporting the development of therapeutic biologics.
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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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Bachelors or advanced degree in a scientific discipline, with a minimum of 10 years of experience working in drug development in the biopharmaceutical industry and at least 8 years of experience in Regulatory Affairs; immunology or rare disease/ orphan drug development experience desirable.
$225,000 - $255,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago
product development drug jobs Title: director in San Mateo, CA
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