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Evaluate and develop the most appropriate biochemical and biophysical characterization tools to support biological drug product development, including adjuvanted vaccine drug products.
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Lead early and late-stage drug product development activities including scale-up, design of experiments (DOEs), risk assessments, and development of the integrated control strategy in partnership with other CMC functional areas, Quality, Regulatory Affairs, and Manufacturing.
$150,000 - $200,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Accordingly, the Clinical Biomarkers & Diagnostics (CBD) function, within Precision Medicine, plays a critical role in advancing our drug development programs and is accountable for the development of biomarker and diagnostics strategy across our pipeline.
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The Senior Director, Assay Development leads product technology development activities including IVD development, automation of NGS protocols, and in-house reagent manufacturing.
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Responsibilities -Develop assays for GMP release of gene therapy products-Develop assays for product characterization of gene therapy products-Develop assays for AAV/protein/DNA to assist in evaluation of process change, formulation andstability study-Report project status (development plans, timelines, and results) to supervisor and technical teams.
$36.11 - $40.54 an hourExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Regulatory, CMC, drug development, pharmaceutical, biotech, chemical engineering, GMP, IND, IMPD/CTA, NDA, MAA. 10+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs and small molecules.
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In this vital role you will be responsible for the development and implementation of the Quantitative Clinical Pharmacology, Modeling and Simulation strategies for cutting-edge novel modalities including Bi-specific T-cell engagers, Bi-specific antibodies, oncolytic viruses, antibody-drug-conjugates, CAR-T cells-based therapies in addition to small molecule & mono-clonal antibodies.
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5+ years of post-PhD experience in biotech industry, ideally in gene therapy or related next-generation drug development field such as biologics. Experience with clinical biostatistics, clinical trial development and/or regulatory filings in the context of therapeutic drug development.
$170,000 - $211,000 a yearExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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At least 4 years direct experience in a pharmaceutical or biopharma technical department or long term project requiring knowledge of the R&D industry and drug discovery and development. At least 6 years experience in large, complex program and project management, including information technology management, systems development, operations, and strategic systems planning and budget planning.
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The Product Marketing Manager will be the main interface between the User Acquisition team, Creative Development, and Game Developer teams to ensure our creative, content, and game portfolio strategy is executed to the highest level.
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As we progress further along the drug development pipeline, you’ll be actively involved in utilizing our platform to forecast preclinical and clinical physiological responses through our proprietary in vivo Mosaic screens.
$70,000 - $80,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Medical Director in Clinical Development is responsible for providing clinical expertise to support the design, conduct, and analysis of clinical and real-world evidence studies in support of GRAIL’s product pipeline as well as commercial launch and post-marketing commitments.
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The Global Development Scientist Director and counterpart Global Development Medical Director work collaboratively in the clinical aspects underpinning a product. Main duties:Work cross functionally within CPT to ensure the clinical strategy is translated into the development of the study concept document, study protocol and related documentsProvide clinical/scientific input into design & implementation of clinical trial(s), their delivery, clinical data review and data cleaning, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product ( clinical input to NDA/BLA.
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Demonstrated expertise in supporting Oncology/Immuno-Oncology cancer vaccine and/or drug discovery programs. Contribute scientifically to oncology drug discovery research programs, particularly cancer vaccines, including identification and validation of antigen epitopes, mechanisms of antitumor T cell response and biomarkers of IO response.
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You will implement machine learning and computational chemistry-based methods to elucidate novel mechanisms of action for small molecule drug discovery. The successful candidate will collaborate extensively with computational and experimental scientists and researchers across gRED to deploy and deliver machine-learning solutions for small-molecule drug discovery.
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product development drug jobs Title: development director Company: Omeros in San Mateo, CA
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