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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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We're looking for someone exceptional to join our growing team as a Sr. Scientist, Formulation & Drug Product Development in the Technical Development Operations group. Collaborate with cross-functional teams, including R&D, Analytical Development, External Manufacturing, Clinical Development, and quality assurance, to ensure seamless project progression.
Full-timeExpandApply NowActive JobUpdated 2 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.
$322,300 a yearFull-timeExpandApply NowActive JobUpdated 8 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.
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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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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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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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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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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 14 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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Reporting to the VP of Drug Safety, this key role will lead the clinical safety activities for the assigned compounds within the organization and is responsible for the implementation, execution, and management of pharmacovigilance and risk management activities for assigned compounds in conjunction with the Company's development and planned commercial activities, industry standards, and compliance with global regulations.
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drug development jobs Title: safety Company: Daiichi Sankyo in Crossville, Tennessee
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