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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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Comprehensive knowledge and understanding of (1) traditional and new modalities of parenteral drug product development (2) parenteral manufacturing and aseptic technologies, and drug product process development.
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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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Using its unique drug discovery pipeline comprised of Artificial Intelligence, virtual screening, molecular docking, high throughput multi-omics sequencing, and human derived induced pluripotent stem cell technologies (hiPSCs), Greenstone Biosciences aims to develop novel drug therapeutics to achieve precision medicine and precision health.
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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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You will lead internal peptide therapeutics development projects from drug discovery to Phase-2 clinical trials. Qualifications: Leading expert in peptide drug discovery and development with a strong record of prior discoveries and/or peer-reviewed publications.
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What Your Qualifications Should Be:Licensed Drug & Alcohol Counselor (LADC) with an active and unrestricted license in Minnesota or an ADC-T.What Your Benefits Look Like:Flexible scheduling options available, FT or PTFree professional development coursework (with supervision available) and free clinical and board-approved CEUs. Opportunities for professional development and career advancement.
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Development, optimization, qualification, transfer, validation, and routine execution of analytical methods for proteins, mAbs, drug conjugates using techniques pertinent to LC (SEC, RP, IEX), LCMS, ELISA, CE-SDS, icIEF, and other wet chemistry techniques.
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Direct experience and expertise in biologics, and/or vaccine drug product development. Execution of scientific formulation activities for preclinical and early clinical studies for the formulation development of solid and liquid drug product presentations.
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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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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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Amgen is currently seeking a Process Development Sr Principal Scientist 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.
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The Head of Product Sciences role is situated within the larger CMC organization responsible for process development, analytical development, technology transfers, manufacturing, and supply of our drug product TCR T cell candidates, drug substance and critical intermediates such as gene editing reagents, viral (LVV) and non-viral vectors.
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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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Oversight and review of drug safety operations practices. Ensure case reports are appropriately scheduled in Argus based on regulatory reporting matrix in conjunction with Drug Safety submissions.
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drug development jobs Title: director Company: System One in Castle-rock, Colorado
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