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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.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Lead drug product development activities to advance new chemical entities (NCE) from the preclinical lead optimization stage through commercialization. Pharmaceutical Development, late-phase drug development, CMC, small molecule, GMP, ICH, FDA, EMA, New Drug Application.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Playing a critical role as the drug product technical lead and CMC project lead, this position will be responsible for drug product development activities leading to NDA submission and commercialization and development and execution of the CMC strategy.
$118 an hourFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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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.
$180,000 a yearFull-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Proactively recommend and plan for future development of Drug Safety and Pharmacovigilance to enable regulatory filings and commercialization, including acquiring QPPV support and the participation in creating Risk Management Plans and a Pharmacovigilance System Master File.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Must have cultivated an appropriate attitude to deal with the challenges of drug development and experienced in regulatory interactions. Be a SME for all DMPK and bioanalysis problem solving and conducting appropriate studies to support different stages of development.
Full-timeExpandApply NowActive JobUpdated 2 months 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.
$322,300 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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The Scientist II Process Development will support the development of protein purification processes. Bachelor’s degree and 5 years of process development or protein purification experience.
$100,000 a yearFull-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Lead and manage multiple drug discovery projects, overseeing the entire drug development process from target identification to preclinical development. Deep understanding of the drug discovery process, including target identification, hit-to-lead optimization, and preclinical development.
$322,300 a yearFull-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Strong background in method development and application of protein LCMS-based assays. Job Title: Senior Research Associate, Drug Metabolism. The primary responsibility of this Biologics Bioanalytical Research Associate is to provide bioanalytical support to DMPK project representatives on biologics discovery teams.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Hands on experience in one or more large molecule immunoassay techniques (ELISA, MSD, Gyros, or similar) is desired. Proven experience with LCMS, particularly in quantitative peptide analysis. Analyze, interpret, document and summarize biologics bioanalytical data.
ExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Excellent problem-solving skills with the ability to troubleshoot LCMS instrumentation and methodologies. Proficiency in data analysis software used in LCMS (e.g., Xcalibur, Analyst). BS/MS degree in biology, chemistry, pharmacology, or related life science discipline with 2+ years relevant experience.
ExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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The Senior Drug Safety IT Systems Manager will ensure high-quality Drug Development Business Applications support. The role will lead the delivery of Support, DevOps, and initiatives in Global Patient Safety (GPS) functions from a Drug Development perspective.
$226,000 a yearFull-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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The Sr. Director, Biologics Drug Substance Development and Manufacturing, will provide technical leadership and subject matter expertise for drug substance process development, tech transfer, scale-up, manufacturing, control strategy development, implementation and process validation.
$255,000 a yearFull-timeExpandApply NowActive JobUpdated 17 days ago - UpvoteDownvoteShare Job
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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.
Full-timeExpandApply NowActive JobUpdated 9 days ago
drug development jobs Title: director safety Company: Biogen in Crossville, Tennessee
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