FDA Fellowship - Applied Regulatory Science In Vitro Molecular Assay Development

Organization

U.S. Food and Drug Administration (FDA)

FDA-CDER-

All documents must be in English or include an official English translation.

If you have questions, send an email to ORISE.FDA.CDER. Please include the reference code for this opportunity in your email.

9/25/2026 3:00:00 PM Eastern Time Zone

Applications will be reviewed on a rolling-basis.

A research opportunity is available within the Food and Drug Administration (FDA) in The Center for Drug Evaluation and Research (CDER), Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), located at White Oak, Maryland.

The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. These efforts cover more than just medicines.

You will contribute to testing therapeutic drug products, including small molecules of regulatory relevance to CDER, using in vitro techniques. The fellowship will also support the evaluation of novel approach methodologies (NAMs) and NAM-enabling technologies. This will include experimental design, testing and analysis of molecular changes associated with drug exposure, application of classical and advanced molecular biology techniques for gene expression and knockdown, cell isolation and culture, development and testing of cell-based models, data analysis, literature review, and manuscript preparation.

• Learn to evaluate therapeutic drug products using in vitro methods relevant to CDER regulatory review.
• Learn to design and conduct experiments supporting off-target safety assessment of small molecule therapeutics.
• Learn to develop and apply advanced laboratory techniques, SplintR-qPCR, and cell fractionation.
• Learn to develop NAMs enabling technologies and assess cell-based NAMs (NAMs).
• Learn to analyze experimental data and interpret findings to inform regulatory science.
• Learn to conduct literature reviews and prepare scientific manuscripts to support regulatory research dissemination.

The mentor for this opportunity is Paula Hyland (paula.hyland.gov). If you have questions about the nature of the research, please contact the mentor.

2026. Start date is flexible and will depend on a variety of factors.

The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.

The appointment is full time.

The participant will receive a monthly stipend commensurate with educational level and experience.

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.

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  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.

If an ORISE Fellow, to include their spouse and minor children,…