FDA Fellowship - Applied Regulatory Science In Vitro Molecular Assay Development

FDA Office and Location: 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 ensuring that safe and effective drugs are available to improve the health of people in the United States. As part of the FDA, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.

About the role

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 includes experimental design, testing, and analysis of molecular changes associated with drug exposure.

Responsibilities

• Design and conduct experiments supporting off-target safety assessment of small molecule therapeutics.
• Develop and apply advanced laboratory techniques, including SplintR-qPCR and cell fractionation.
• Develop NAM-enabling technologies and assess cell-based NAMs.
• Analyze experimental data and interpret findings to inform regulatory science.
• Conduct literature reviews and prepare scientific manuscripts to support regulatory research dissemination.
• Apply classical and advanced molecular biology techniques for gene expression and knockdown, cell isolation, and culture.
• Develop and test cell-based models.

Learning Objectives

• Evaluate therapeutic drug products using in vitro methods relevant to CDER regulatory review.
• Design and conduct experiments supporting off-target safety assessment of small molecule therapeutics.
• Develop and apply advanced laboratory techniques, such as SplintR-qPCR and cell fractionation.
• Develop NAM-enabling technologies and assess cell-based NAMs.
• Analyze experimental data and interpret findings to inform regulatory science.
• Conduct literature reviews and prepare scientific manuscripts for regulatory research dissemination.

Qualifications

The qualified candidate should be currently pursuing or have received a doctoral degree in molecular biology, cell biology, genetics or genomics, biomedical sciences, pharmaceutical sciences, or a closely related discipline. Degree must have been received within the past five years or be anticipated by 8/30/2026.

Skills

• Strong background in molecular biology techniques, including DNA/RNA extraction, quantitative PCR (qPCR), and nucleic acid assay development and optimization (e.g., ligation-based assays).
• Experience with mammalian cell culture using 2D and/or 3D cell models and the design and execution of in vitro experiments.
• Experience characterizing cellular responses to drug treatment, with strong quantitative data analysis and interpretation skills.

Benefits

• Monthly stipend commensurate with educational level and experience.
• Proof of health insurance is required for participation.
• Appointment is full-time and initially for one year, renewable upon recommendation and contingent on the availability of funds.

Schedule

Applications will be reviewed on a rolling basis. The anticipated appointment start date is 2026, with flexibility depending on various factors.

Mentor: Paula Hyland (paula.hyland@fda.hhs.gov). For questions about the research, contact the mentor.

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 for acceptable immigration statuses.