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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.
$108 - $118 an hourFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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7 years of clinical development experience including 4 years’ direct involvement in drug safety/pharmacovigilance activities. The individual will supervise and mentor the Drug Safety Department staff and effectively collaborate with other department heads within Development, team leaders and other relevant functions.
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The Principal Toxicologist will be responsible for the design and execution of nonclinical development toxicology studies conducted externally, interpretation and communication of the toxicology data/reports to support drug development decisions, and for summarizing and writing regulatory submissions.
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Direct the planning and implementation of process development, scale-up, technology transfer, and validation efforts in drug substance manufacturing, ensuring strategic alignment and operational excellence.
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In this vital role you will support Formulation & Drug Product Development at Amgen's site in Rockville, MD. This group is responsible for drug product formulation and process development for biologics in Amgens Rare Disease Business Unit. Working closely with a team of scientists and engineers, the successful candidate will apply scientific and engineering principles to advance the technical aspects of Amgens drug product and process development.
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Reporting to the Vice President, CMC, the Director will manage and lead the Analytical development function ensuring the development and implementation of phase appropriate methods that meet international regulatory requirements for drug substance and drug product safety.
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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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Participate in drug product development teams and contribute to the planning and execution of product development studies including formulation and drug product process development, based on project goals and timelines.
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The Drug Use Policy (DUP) Pharmacist at Cedars-Sinai Medical Center in Los Angeles, California is responsible for strategic planning for biologics and therapeutic advances; collaborating with medical staff in development of evidence based guidelines; evaluating new drugs for the formulary.
$143,100 - $228,900 a yearFull-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Your extensive experience and expertise in Neuroscience drug development will play a pivotal role in shaping the future of our research endeavors! Maintain an excellent grasp on emerging areas of immunology and neuroscience research that are potential competitive advantages, including engaging in external collaborations in support of our discovery and development programs.
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Apply knowledge throughout the drug product development life-cycle to develop novel therapeutics to treat a variety of diseases. The Attribute Impact Group in the Department of Attribute Sciences is seeking a Process Development Scientist to investigate the impact of key product quality attributes on the safety and efficacy of biotherapeutics.
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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modeling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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Reporting to the Vice President, CMC Operations, the Head of/Senior Director CMC Operations (Drug Substance) will manage activities related to Process Development, Tech Transfer and Manufacturing of Drug substance.
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Perform cutting-edge research that evaluates the impact of attributes on various quality aspects of drug products using a combination of protein chemistry, immunology, and physiology. Process Development Scientist.
$107,234 - $129,162 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The Executive Director, CT Technical Operations Drug Product will have global responsibility in providing strategic leadership and direction for product support for commercial cell therapy products manufactured globally.
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drug development jobs Title: director safety performance in Crossville, Tennessee
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