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Research Project Description

PAT and Bioprocessing Fellowship
Division of Monoclonal Antibodies
Office of Biotechnology Products
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Silver Spring, MD

FDA-CDER-2014-0029

Project Description:

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

OBP protects public health by assuring the quality, safety, efficacy, availability and security of therapeutic protein and monoclonal antibody products. The selected participant will join a team that studies the feasibility of Process Analytical Technology (PAT) testing in bioprocessing with the specific aim of better controlling antibody critical quality attributes (CQAs). Conventional biopharmaceutical cell culture involves multiple input factors, such as media type and feed strategy, cell state and bioreactor engineering settings, all of which can contribute to protein product variability. PAT is an approach to improving product consistency by introducing real-time monitoring and control of product quality. The laboratory environment has state-of-the-art instrumentation in lab-scale protein production bioreactor cell culture, preparative scale chromatography and advanced analytical instrumentation. This team-based project has the potential to lead to improvements in how the stability, potency, safety and efficacy of biotechnology-derived biologic drugs are achieved.

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 Doctoral degree in biochemistry, microbiology, chemical engineering or molecular biology received within the last five years. Candidates with Master’s degrees in one of the aforementioned fields and with relevant experience will also be considered.
  • Experience with bioprocessing, bioreactor cell culture or chromatographic protein separation 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-2014-0029 in all communications.