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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 pre-formulation, final form selection, formulation and process development, clinical manufacturing, scale-up, tech transfer, process optimization, and process validation activities related to solid oral dosage and parenteral drug products.
$108 - $118 an hourFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Strong subject matter expertise in immune-oncology, cell therapy drug discovery and development including CMC considerations, CAR design, engineering and armoring strategies, innate immune cells such as NK and gamma delta for the purposes of leading drug development projects from start to the clinic.
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In addition, the Manager Drug Product Development and Manufacturing will support all aspects of non-GMP and GMP drug product manufacturing and ensure that the CMC team is aligned with the manufacturing strategy at each CMO. A strong knowledge of sterile parenteral filling and the requirements of clinical supply manufacturing is required as well as a working knowledge of cGMP and FDA/EMA guidelines.
$150ExpandUpdated 7 days ago - UpvoteDownvoteShare Job
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The successful candidate should have strong expertise in immuno-oncology and will be focused on focus on the development of fit-for-purpose CMC assays using flow cytometry and cell-based immunoassays, to characterize engineered TCR-T cell drug substance and drug product.
$150ExpandUpdated 8 days ago - UpvoteDownvoteShare Job
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You will join the Drug Product Development team responsible for formulation and drug product process development, scale-up, and technology transfer for novel viral vectors being developed for in vivo gene therapy.
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Using its unique drug discovery pipeline comprised of Artificial Intelligence, virtual screening, molecular docking, high throughput multi-omics sequencing, and human derived induced pluripotent stem cell technologies (hiPSCs), Greenstone Biosciences aims to develop novel drug therapeutics to achieve precision medicine and precision health.
$150ExpandUpdated 7 days ago - UpvoteDownvoteShare Job
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The Associate Director of Analytical Development will play a key role in leading the development, validation, and transfer of analytical methods for ophthalmic drug delivery systems.
$150ExpandUpdated 7 days ago - UpvoteDownvoteShare Job
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Comprehensive knowledge and understanding of (1) traditional and new modalities of parenteral drug product development (2) parenteral manufacturing and aseptic technologies, and drug product process development.
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Employment with ABARTA Coca-Cola Beverages, LLC is contingent on a pre-employment background check which may include drug screening, driving records (including minor moving violations) and will be evaluated according to ABARTA Coca-Cola Beverages, LLC guidelines to determine eligibility for this position.
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Demonstrated technical expertise in CNS-relevant drug targets, assay development and workflow design and maintenance are essential skills. Lead drug discovery drug discovery project teams in neuropsychiatry, neurology, or neuroendocrinology to deliver high quality molecules to clinical development.
$150,700 - $218,500 a yearFull-timeExpandUpdated 11 days ago - UpvoteDownvoteShare Job
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They will work within the Analytical Development team to characterize drug substance, drug product, impurities, degradants, and metabolites from pre-clinical research through drug development and commercialization.
$200Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Clinical Pharmacology, Modeling & Simulation Department at Amgen is seeking a Senior Principal Scientist to join the cross-functional global drug development teams at its South San Francisco, CA location.
$250ExpandUpdated 8 days ago - UpvoteDownvoteShare Job
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You will be responsible for working with clinical, cross-functional study teams, and third party vendors/CROs to manage and support drug safety and pharmacovigilance operational activities and deliverables across Tango's clinical development portfolio.
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Lead matrixed Drug Product teams to advance formulation development, fill/finish process development, process characterization, container development, packaging development, technology transfer, and regulatory authoring of our mRNA portfolio candidates in late-stage development.
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What Your Qualifications Should Be:Licensed Drug & Alcohol Counselor (LADC) with an active and unrestricted license in Minnesota or an ADC-T.What Your Benefits Look Like:Flexible scheduling options available, FT or PTFree professional development coursework (with supervision available) and free clinical and board-approved CEUs. Opportunities for professional development and career advancement.
$62,000 a yearFull-timeExpandUpdated 7 days ago
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