Research Project Description
Therapeutic Protein Glycosylation Fellowship
Office of Biotechnology Products
Division of Therapeutic Proteins
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
A postdoctoral fellowship is available within the Office of Biotechnology Products of the Division of Therapeutic Proteins in the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA). The selected participant will join a multi-disciplinary team to study the formation and biological impact of post-translational modifications introduced into therapeutic proteins during the biosynthetic and purification processes. The participant will also be helping in the development of analytical tools for a rapid analysis of protein glycosylation.
Focusing on protein glycosylation, opportunities may include:
- Assessing the impact on product safety and bioactivity, particularly as it relates to the evaluation of biosimilar protein products
- Identifying and developing analytical tools that can be used to better assess the quality of therapeutic proteins
- Learning the techniques for the assessment of product quality of protein drug products
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 NIH in the Bethesda, Maryland, area. The laboratory is located on the main campus of National Institutes of Health in Bethesda, MD, with access to its library, seminars, and core facilities. Participants do not become employees of FDA or the program administrator, and there are no fringe benefits paid.
- A Doctoral or Medical degree received within the last five years with experience in molecular biology and protein biochemistry.
- Experience using mass spectrometry to study protein glycosylation and other modifications 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-2014-0005 in all communications.