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Working knowledge of lyophilization cycle development, GMP drug product fill and finish, lab automation, data science, and knowledge management. Extensive experience with formulation development and tox/clinical in-use evaluation for monoclonal antibodies, bispecifics, antibody-drug conjugates, fusion proteins, and other complex biologics formats, in a wide concentration range from ultra low to high; experience of IND and/or BLA filings.
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Knowledge & Other Requirements Knowledge of the drug development process, Good Clinical Practices (GCP) and Good Pharmacovigilance (GVP), including worldwide PV regulations and their application to safety science activities (aggregate PV reports, risk management plans, signal detection, clinical trials and clinical development.
$274,635 - $355,410Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Responsible for integrating translational research and clinical development to develop a biomarker strategy in alignment with clinical development objectives, leading efforts for data generations, interpretation and communication to the development team.
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This role requires collaboration with the Development, Quality, Regulatory, Analytical, Supply Chain, and Product & Portfolio Strategy organizations within PDM to ensure successful technology transfer, commercialization, launch, routine supply, and proactive management of changes across the product lifecycle from launch to sunset/divestiture.
$133,280 - $172,480 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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A minimum of 2 years of experience in contracts management of clinical trials, preferably in a small biotech environment industry drug, biologic, vaccine development experience. Reports to: Senior Director, Supply Chain Strategy and Sourcing Location: San Carlos, CA Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
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Lounge Lizard is a Digital Agency that Specializes in Brand Strategy, Website Design, Web Development, Mobile APP Development, Online Marketing, Social Media, Ecommerce, and SEOdigital experiences that move brands and businesses from now to next.
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Ensures the effectiveness of the CMC Regulatory team in developing submissions and in working across functions (such as Drug Product Development, Drug Substance Development, Analytical/QC, and Quality teams.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Knowledge of the drug development process, Good Clinical Practices (GCP) and Good Pharmacovigilance (GVP), including worldwide PV regulations and their application to safety science activities (aggregate PV reports, risk management plans, signal detection, clinical trials and clinical development.
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The Executive Director, CMC Regulatory Affairs is responsible for developing and directing the regulatory CMC strategy, objectives, and programs pertaining to development and marketing of drug products.
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Rezolute is seeking an experienced chemist, chemical engineer, or pharmaceutical scientist to lead the CMC development programs for our portfolio of small molecule drug candidates. They will be responsible for all aspects of CMC strategy, process - analytical development and cGMP manufacturing.
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5+ years in product planning preferred, with relevant professional experience in new product planning, market planning, corporate development and/or healthcare strategy consulting considered.
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Extensive experience in drug development, commercialization of drugs and direct interaction with the FDA and international regulatory agencies is highly desirable. Understanding of the complexities and regulations of drug development, drug commercialization, launch and lifecycle management as well as the proven ability to translate medical insights into relevant strategies, tactics and operational plans for the medical affairs function.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Minimum of 5 years of experience in biopharma business development, corporate development, or strategy as operator, consultant, investor or financial services. Execute on business development strategy to achieve exceptional key results aligned with corporate objectives and our mission to design next-generation antibodies for patients.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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In this role, you will be a leader that will develop and implement US and global clinical operations strategy for ReCode’s Cystic Fibrosis (CF) program and make strategic contributions to our product development plan.
Full-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Demonstrated success supporting complex programs involving dozens of stakeholders to goal achievement including development of complex drug development project strategy. Working closely with Clinical Operations, Pre-Clinical Development, Regulatory and CMC functions, the Director Program Management will drive development strategy and tactical execution of the assigned programs throughout their life cycle (discovery/acquisition though development and commercialization.
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drug development strategy jobs in Redwood City, CA
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