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Research Project Description

Sterile Filtration of Pharmaceuticals Fellowship
Office of Biotechnology Products
Office of Pharmaceutical Sciences
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Silver Spring, MD

FDA-CDER-2014-0033

Project Description:

A fellowship opportunity is currently available in the Office of Biotechnology Products (OBP) within the Office of Pharmaceutical Sciences (OPS) at the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA). 

The selected participant will join a lab and regulatory team studying the issues, gaps and opportunities for improvement related to sterile filtration of pharmaceuticals. S/he will be exposed to state-of-the-art instrumentation in lab-scale filtration and other pharmaceutical processes, as well as advanced analytical instrumentation. This project has the potential to lead to improvements in how the microbial safety of brand name, generic and biotechnology-derived drugs is achieved. The project will involve close collaboration with the OPS microbiology staff who will identify areas of investigation and emphasis for the research program.

The Research Participation Program for FDA is administered by the Oak Ridge Institute for Science and Education (ORISE). The initial appointment is for one year, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend depending on educational level and experience. The participant must show proof of health insurance. The appointment is full-time at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA or the program administrator, and there are no fringe benefits paid.

Qualifications:

  • A Bachelor’s or Master’s degree in microbiology, chemical engineering or a closely related field received within the last five years.
  • Experience with microbiology or filtration in a research setting is preferred.

How to Apply:

To be considered, please send a current CV/resume to the attention of FDArpp@orau.org. Please reference FDA-CDER-2014-0033 in all communications.