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Lead strategic communications counsel for and in support of the SVP, Heads of Drug Development for Immunology, CV and Neuroscience and Hematology/Oncology. Act as main point of contact for the SVP, Heads of Drug Development for Immunology, CV and Neuroscience and Hematology and Oncology in thought leadership initiatives designed to elevate the company’s scientific reputation in these therapeutic areas.
Full-timeExpandApply NowActive JobUpdated 29 days ago - UpvoteDownvoteShare Job
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Playing a critical role as the subject matter expert (SME) and project lead of Pharmaceutical Development within CMC function, the position will be responsible for preformulation studies, formulation and process development, drug delivery design, optimization, scale-up and manufacturing in support of Revolution Medicines pipeline compound development and clinical programs.
$160,000 - $200,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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This will include formulation and commercial process development for biologics (monoclonal antibodies, antibody drug conjugates, bispecifics and fusion proteins). The Biologics Drug Product Development group develops monoclonal antibodies, antibody drug conjugates (ADC), and other biologics using state of the art formulation and process technologies.
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The Director, Drug Safety is responsible for planning, directing, coordinating and prioritizing activities of the product safety team and providing oversight of Pharmacovigilance (PV) vendors in all aspects of PV activities for products both marketed and in development.
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Engineering Director (Scientific) – Drug Product Development. The drug product team is also investing in building new platforms to support complex formulations such as lipid nanoparticles, Antibody Drug Conjugates and AAV and other non-viral vector delivery.
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Our Small Molecule Drug Substance Development and Manufacturing team has an opportunity for Scientist position to support our small molecule drug development pipeline. Work in a team of Arcus scientists and partner contract development and manufacturing organization teams to develop efficient manufacturing processes for small molecule drug substance preparation under GMP. The projects may encompass clinical stage candidates through commercial launch.
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This Co-Op Associate Scientist will be exposed to a wide variety of phsiochemical assays (U/HPLC, Capillary Electrophoresis, DLS, DSC, subvisible particle analyses) and drug product development processes (including clinical in-use studies, photosensitivity studies, protein deep characterization, and drug product stability studies), and work on sample testing, method transfer, optimization and development.
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In this role, you will lead device mechanical modeling and simulation projects, including finite element analysis (FEA) simulations, to enable drug delivery device development, drug product packaging operations and biopharmaceutical manufacturing processes.
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This position will be an integral part of the product development and CMC teams and will have strong collaborations with the Pre-formulation, analytical, process development functions, the Drug Product Pilot Plants, third party manufacturers and AbbVie’s Operations S&T and Commercial Manufacturing functions.
Full-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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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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Requires a highly motivated individual with a PhD and 14+ years of post-graduate industry experience in the fields of pharmacokinetics, drug metabolism, pharmaceutics, or related life science field primarily supporting the PK characterization of large molecule/biologics through discovery and development.
$230,860 - $298,760 a yearFull-timeExpandUpdated 30 days ago - UpvoteDownvoteShare Job
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Development experience in oncology drug development, immune oncology agents, a plus. Final author for all regulatory safety documents, e.g., Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), template informed consents, Investigator Brochures.
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Knowledge, Experience and Skills:Requires a highly motivated individual with a PhD and 14+ years of post-graduate industry experience in the fields of pharmacokinetics, drug metabolism, pharmaceutics, or related life science field primarily supporting the PK characterization of large molecule/biologics through discovery and development.
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Serve as clinical pharmacology lead and pharmacometrics representative on multiple project teams and support model-based drug development strategies for ongoing projects. Great working knowledge of formulation development, drug development and clinical development.
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