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FDA Drug Safety Research

FDA Drug Safety Research

A research opportunity is available in the Office of New Drugs/Office of Drug Evaluation I, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) located in Silver Spring, Maryland.  If you are interested please apply on under the advertisement number FDA-CDER-2019-0469.  Additionally, please submit your CV to

This project is a collaboration between the Office of New Drugs/CDER and the Office of Science and Engineering Laboratories/CDRH. The agency receives submissions on newly evolving bioresorbable polymer-based drug formulations for endovascular interventions, open vascular wraps, and hemodialysis access grafts. To better understand the suitability of bioresorbable polymers, a rapid assay will be developed to determine cytocompatibility of bioresorbable polymer formulated drugs. The proposed study will identify predictive biomarkers of biocompatibility that include prothrombotic factors, proinflammatory mediators, proadhesion molecules, and prooxidant species. The results of the proposed study will provide 1) a rational basis for the assessment of safety of polymer carriers and 2) requirements for biocompatibility testing.

Under the guidance of a mentor the participant will receive training on the critical role of biocompatibility testing in the assessment of safety for biomaterials that interact with the human body. The laboratory project will then evaluate various biodegradable polymers in cultured endothelial cells to determine their effects on the release of markers of inflammation and thrombosis. The participant will learn how to conduct laboratory research to develop in vitro screening assays to evaluate and optimize biocompatibility of polymers that are used as drug carriers, utilizing techniques such as cell culture, quantitative real-time polymerase chain reaction (RT-PCR), flow cytometry, immunoblotting, mRNA expression, ELISA, immunofluorescence, and Luminex assays.

Desired Candidate:

The qualified candidate should have received a bachelor's degree in one of the relevant fields: biology, toxicology, pharmacology, basic biomedical sciences, cellular and molecular biology, or chemistry. Degree must have been received within five years of the appointment start date.

Familiarity with cell and molecular biology laboratory techniques (e.g., cell culture, mRNA extraction, preparing sterile solutions), endothelial cell cultures, in vitro cytocompatibility assays, biocmpatability testing protocols, bioresorbable polymers is desired.

Celene Moorer, MS
Science Policy Analyst, OND Research Program

Center for Drug Research and Evaluation (CDER)
Office of New Drugs, Office of Drug Evaluation Services (OND/ODES)

Division of Biomedical Informatics, Research, and Biomarker Development (BIRBD)
U.S. Food and Drug Administration (FDA)

Tel: +1 (240) 402-0556

10903 New Hampshire Ave, Bldg. 22, Rm. 4215

Silver Spring, MD 20903