Postdoc - FDA Internship on Analytical Method Development for Complex Drug Analysis

The pharmaceutical analysis conducted in CDER labs includes in-depth analysis of complex and biologic drug products. Research activities require extensive experimental research to generate the data and results important to advance regulatory science and to support drug product quality research.

The project will aim to develop validated NMR, DLS and FPLC methods to assess the identity, purity, content and higher-order structure of biologic protein drugs and complex generic drugs of novel oligonucleotide. The resulting analytical data will support product-specific guidance development, regulatory review, and scientific evaluation of complex generic and biosimilar drug products, thereby strengthening the FDA's regulatory science.

This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.

Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA.  OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.

This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.