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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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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 drug product development activities to advance new chemical entities (NCE) from the preclinical lead optimization stage through commercialization.
$108 - $118 an hourFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The Vice President, BioPharmaceutical Development is a strategic leader responsible for oversight of Cell Line Development, Cell Culture Sciences, Purification Sciences, Analytical Sciences and Drug Product Sciences.
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As an Associate Digital Product Manager in IT & Digital, you will have a critical role in overseeing the product strategy, development/implementation and management of technology products in different focus areas in Global Drug Safety and Pharmacovigilance.
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Perform routine assays for drug product release and characterization. Experience working with Python/R in bioinformatics data analysis, SQL data management, and data visualization tools such as Power BI or Tableau.
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Interact cross functionally and work closely with teams include stem cell biologists, chemists, structural biologists, software engineering, clinical, laboratory operations, research, and product development.
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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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SUMMARY/JOB PURPOSE: The Senior Staff Engineer, Product Management - Business Applications will ensure high-quality Drug Development Business Applications support. KNOWLEDGE/SKILLS:Thorough knowledge of all aspects of Pharmacovigilance systems, such as Argus, Axway, Signal Management, Reporting and Analytics (Tableau, Spotfire), EDC, and AWS.Demonstrated ability to participate with businesses in launching technologies to support drug launches and deliver large, complex programs involving system and process reengineering and integration.
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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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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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Project management skills and experience working in a cross functional stage/gate product development process. The Product Development Engineer applies technical knowledge, original thinking, and ingenuity to solve design problems and develop new products and systems.
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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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OverviewAbout B. Braun B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry.
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We are a market leader in automated bio sample management solutions and genomic services across areas such as drug development, clinical and advanced cell therapies for the industry's top pharmaceutical, biotech, academic and healthcare institutions globally.
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The Opportunity: The Hardware Product Development Manager role will be a key team member for physical product development at Caraway. You will own end-to-end product development (NPI) from concept through launch, including defining product requirements, prototyping, manufacturing, marketing, and strategy.
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product development management drug jobs Title: development Company: Omeros
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