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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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Extensive experience in late-phase drug product development and commercial development with CMC regulatory filings for the US (NDA), Europe (MAA), Japan, and China. Leadership experience in late-stage product development, scale-up, tech transfer, and process optimization of solid oral dosage and parenteral formulations is a plus.
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Using these and other proprietary tools, we can scale in vivo efficacy testing to more targets than have ever been explored by biopharma, at the very beginning of the drug discovery process (more info on our website.
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Head of CMC Operations (Drug Substance) will manage activities related to Process Development, Tech Transfer and Manufacturing of Drug substance. Managing complex and intertwined scientific/technical and operational logistical CMC related activities, the position will support the Company's drug development and manufacturing activities for phase 3 and commercialization at external Contract Development and Manufacturing Organization (CDMO) and Contract Testing Labs (CTL.
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Process Engineering also partners with Biologics CMC Development and Aesthetics R&D functions to provide active engineering support to enable robust process scale-up and manufacturing of biologics drug substances and drug products, including toxins and cosmetic active ingredients (CAIs.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Reporting to the Vice-President of Manufacturing Operations and Supply Chain, the Sr. Director, Pharmaceutical Sciences will be responsible for leadership of the Pharmaceutical Science and Analytical Development teams and will have ownership of R&D operational support for early and mid-phase programs including formulation development, process development and analytical development, management of CMOs, process tech transfer and scale up.
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The Biotherapeutics mammalian expression group supports medium to large scale (2 to 100L) expression of antibodies and therapeutic biologics in support of AbbVie's worldwide drug discovery efforts.
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Insitro is a drug discovery and development company using machine learning (ML) and data at scale to decode biology for transformative medicines. Strong knowledge of a broad range of nonclinical studies relevant to drug development (Toxicology, DMPK, Bioanalytical, Biology, Pharmacology.
$240,000 - $300,000 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Provide strategic direction and guidance to the formulation development team on all aspects of injectable small molecule, peptide, and protein formulations, including process development, characterization, scale-up, tech transfer and manufacturing support.
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Responsible for all aspects drug substance including conjugation process development, validation, characterization, scale-up, tech transfer, analytical method qualification, specifications, release and stability testing.
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Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.
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Oversee CROs to produce recombinant proteins and antibodies for in vitro screening and scale-up for in vivo studies, manage in-house inventory, help build LIMS and lab as company grows. Understanding of cell line development and CMC activities.
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Amgen is currently seeking a Sr. Associate– Analytical Chemist in our Pivotal Attribute Sciences Department in Cambridge, MA. This team plays a crucial role in pivotal phase analytical development, including method development, validation, transfer, process and product development support, and GMP testing of drug substances and drug products.
Full-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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The Immunology and Immunochemistry disciplines support large molecule drug development using ligand binding assays, such as enzyme-linked immunosorbent assay, to measure large molecules and their immune responses.
$75Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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The successful candidate will apply scientific principles and utilize/Operate Disposable bioreactor systems ranging from 2L to 500L scale, various filtration techniques, and separation technologies to improve current commercial and develop next-generation processes of monoclonal antibodies and recombinant proteins, with responsibilities spanning bench and pilot-scale process development & characterization, as well as the support of technology transfer to manufacturing facilities.
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