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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.
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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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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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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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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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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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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.
$71,200 - $80,100ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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This position will be responsible for developing and executing robust epidemiology plans for Genmab product portfolio and pipeline in alignment with clinical development, global drug safety and pharmacovigilance and commercialization strategy.
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Partner with Global Drug Safety and Pharmacovigilance and Compound Development Teams to interpret and refine potential safety signals during drug development through signal evaluation techniques using epidemiologic methods.
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Accountable for epidemiology content in regulatory and safety deliverables, including benefit-risk assessments, Risk Management Plans, orphan drug applications, pediatric investigation plans, DSUR and PBRER.
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Accountable for strategy and conduct of regulatory agency required epidemiologic studies such as PASS, PAES, PMR, DUS in partnership with Global Drug Safety and Pharmacovigilance. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.
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The qualified individual will be responsible for the design, execution, and management of scientific studies in the development of both liquid and /or lyophilized drug product formulation to support product development from initial candidate identification through commercialization.
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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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Downstream Bioprocess – Technical Services/Manufacturing Scientist (TS/MS) role is responsible for providing technical support for the development, implementation, and technical transfer of compliant manufacturing of gene therapy drug substance and drug product for clinical and commercial manufacture.
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Partner with manufacturing and QC to provide analytical development expertise for drug product release, characterization, and scaling. Ph. D. in analytical sciences, biophysics, biochemistry, pharmaceutical sciences, or a related field with at least 12+ years of laboratory experience in an industrial setting and experience in CMC strategy and/or drug development leadership.
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product development management drug jobs Title: director Company: Omeros
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