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Pharmaceutical Scientist (Research)
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- The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and effective.
- CDER’s drug regulatory responsibilities include premarket review of new drugs and generic drugs; maintenance of the OTC drug monograph system; monitoring of all marketed drug safety and promotion activities; review, monitoring, and enforcement of drug quality during the entire drug life cycle; and ensuring drug products in the market comply with the law.
- The Office of Testing and Research (OTR) conducts laboratory research on manufacturing, formulation, and characterization of drugs, and provides advice/consults, collaborative research opportunities, and scientific training to FDA staff on pharmaceutical quality, pharmaceutical equivalency, and bioavailability/bioequivalence issues including manufacturing, formulation, analytical testing, and modeling.
- As a Research Scientist, the incumbent serves on multi-disciplinary scientific teams and provides technical guidance in research activities which generally include the characterization of drug products, its formulation and manufacturing process as it relates to drug delivery, in vitro drug release and in vivo drug performance.
- Develops advanced manufacturing approaches for drug substances and drug products including understanding of excipients effects, design of experiments, control strategies, and modeling.
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