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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 1 month ago - UpvoteDownvoteShare Job
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Experience in oncology drug development. Extensive training and experience in the design and conduct of in vitro and in vivo preclinical pharmacology and toxicology studies directed at the development of pharmaceuticals or biologics.
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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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Interface within the DPT department and with other Amgen functions, such as Drug Substance Technologies, Attribute Sciences, Quality Assurance, Regulatory Affairs, Supply Chain, Contract Manufacturing, Pharmacokinetics and Drug Metabolism, Clinical Development, Biostatistics, etc.
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Participate in drug product development teams and contribute to the planning and execution of product development studies including formulation and drug product process development, based on project goals and timelines.
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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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Demonstrated competency and experience with biological, vaccine or preferably viral vector formulation and drug product development to enable GMP production. Drive innovation for viral vector formulation and drug product process development including internal and external presentations, IP filings, and evaluation of new technologies.
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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-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Direct experience and expertise in biologics, and/or vaccine drug product development. Execution of scientific formulation activities for preclinical and early clinical studies for the formulation development of solid and liquid drug product presentations.
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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 Manager of Drug Safety & Pharmacovigilance (PV) Quality, is a key role and is responsible for oversight of Drug Safety & PV quality, compliance, and alliance management activities, thus always promoting inspection readiness and maintaining a robust global compliance program within the Quality Assurance department.
$150,000 - $190,000 a yearFull-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Understanding of standard drug development process, defining in vivo pharmacology, assessing PKPD and deriving margins to provide clinical starting doses. Conceptualize and design strategies for drug discovery using insitro's platforms from hit to lead using industry standard preclinical pharmacology models and standard drug development models by applying insights exposed by insitro's unique target discovery credentialization.
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The Associate Director, Drug Product Process Development, reporting to DP Technologies (DPT) in Global Biopharmaceutical Development (GBD), is a critical role in our development team and will help lead the successful development and commercialization of biologics product candidates.
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The role will lead the delivery of Support, DevOps, and initiatives in Global Patient Safety (GPS) functions from a Drug Development perspective. EXPERIENCE/THE IDEAL FOR SUCCESSFUL ENTRY INTO JOB:Cultivates and demonstrates an in-depth knowledge of Drug Development business capabilities focused on Patient Safety.
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Represent Drug Product team in CM&C teams and support the formulation and process development of protein, peptide, oligonucleotides and other novel modalities in clinical development.
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drug development jobs Title: director safety Company: Canyon Coach Lines in Crossville, Tennessee
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