FDA Protein Biochemistry Fellowship
*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of Pharmaceutical Quality/Office of Biotechnology Products, Center for Drug Evaluation and Research (CDER), Food and Drug Administration in Silver Spring, Maryland.
This project in the Office of Pharmaceutical Quality/Office of Biotechnology Products will address how quality different biological, physical, and chemical factors influence the safety and efficacy of a protein drug. These factors could impact critical product attributes during the manufacture, storage, and/or usage of the drug. One of the major influences on the stability and performance of a protein drug is its formulation. Excipients that are added to stabilize proteins can and do disrupt the safety and efficacy of products, under certain circumstances. A multi-disciplinary approach is critically needed to understand their impact and mechanism in order to understand their realistic clinical impact and make sound regulatory assessments.
Under the guidance of a mentor the participant will be trained on protein biochemistry and the impact of protein oxidation using in vitro and in vivo models. Activities may include orthogonal validation experiments utilizing specialized equipment to characterize the structure-function relationship between oxidation and drug purity, potency and immunogenicity. This training will prepare the participant for a successful career transition into regulatory science research.
Qualifications
The qualified candidate should have received a master's or doctoral degree in one of the relevant fields, with familiarity of protein biochemistry research areas. Degree must have been received within five years of the appointment start date.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2020-0529) in your email.