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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.
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Ordaos is seeking a Principal Scientist of Drug Development to be a part of our ongoing mission to create bespoke mini-proteins to enable ground-breaking therapeutics. Act as project manager and strategist on Ordaos internal and external drug discovery and development projects.
$140,000 - $180,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The candidate will be a part of the Biologics Drug Product Development team in support of Gene Therapy programs in the Genomic Medicine Unit. The incumbent will have the opportunity to work on different facets of drug delivery and product development for modalities such as Lipid Nanoparticles (LNPs) and Adeno-associated virus (AAV.
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Background encompasses manufacturing process development of parenteral drug product, including oligos, protein, peptide, viral or cell therapeutics. Extensive experience in parenteral drug product process development.
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Senior Director, Drug Substance Position Summary Reporting to the VP, Head of CMC Development, the Senior Director, Drug Substance will be responsible for leading the drug substance team in development and manufacturing as part of PepGen ́s CMC team.
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7 years of clinical development experience including 4 years’ direct involvement in drug safety/pharmacovigilance activities. The individual will supervise and mentor the Drug Safety Department staff and effectively collaborate with other department heads within Development, team leaders and other relevant functions.
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The Principal Toxicologist will be responsible for the design and execution of nonclinical development toxicology studies conducted externally, interpretation and communication of the toxicology data/reports to support drug development decisions, and for summarizing and writing regulatory submissions.
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Direct the planning and implementation of process development, scale-up, technology transfer, and validation efforts in drug substance manufacturing, ensuring strategic alignment and operational excellence.
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In this vital role you will support Formulation & Drug Product Development at Amgen's site in Rockville, MD. This group is responsible for drug product formulation and process development for biologics in Amgens Rare Disease Business Unit. Working closely with a team of scientists and engineers, the successful candidate will apply scientific and engineering principles to advance the technical aspects of Amgens drug product and process development.
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Reporting to the Vice President, CMC, the Director will manage and lead the Analytical development function ensuring the development and implementation of phase appropriate methods that meet international regulatory requirements for drug substance and drug product safety.
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As drug therapies become more sophisticated, Lilly has expanded our product capabilities to include the design and development of consumer-friendly, innovative, and award-winning drug delivery systems.
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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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Novo Nordisk is seeking a highly motivated analytical support specialist to join the Analytical Development team in Boulder, CO. The candidate will be responsible for various analytical laboratory activities including but not limited to: method development and transfer of methods for oligonucleotide intermediates (IPC's) as well as drug substance and drug product release within a nonGMP lab.
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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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The Drug Use Policy (DUP) Pharmacist at Cedars-Sinai Medical Center in Los Angeles, California is responsible for strategic planning for biologics and therapeutic advances; collaborating with medical staff in development of evidence based guidelines; evaluating new drugs for the formulary.
$143,100 - $228,900 a yearFull-timeExpandApply NowActive JobUpdated 2 months ago
drug development jobs Title: director safety Company: Astrazeneca Gmbh in Crossville, Tennessee
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