FDA Postdoctoral Fellowships in Cell and Gene Therapy

Organization

U.S. Food and Drug Administration (FDA)

FDA-CBER-

9/30/2026 3:00:00 PM Eastern Time Zone

• Applications will be reviewed on a rolling-basis.

Two postdoctoral ORISE Fellowships are available in the laboratory of Dr. Nirjal Bhattarai in the Office of Therapeutic Products (OTP) at the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA), in Silver Spring, Maryland.

The Center for Biologics Evaluation and Research (CBER) is one Center within the Food and Drug Administration, an Agency within the United States Government's Department of Health and Human Services. CBER's mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies.

This project focuses on improving the safety of gene therapy products, including AAV vectors, through mechanistic and translational laboratory studies. The fellow will assess quality attributes (CQAs) that may influence safety-related outcomes, such as immunogenicity and inflammatory toxicities. Using various model systems, the fellow will identify process parameters that are safety-relevant and develop strategies to mitigate these risks while preserving overall product performance.

This project focuses on developing NAMs for the safety and efficacy assessment of gene therapy products, including AAV vectors and gene-modified immune cells. The fellow will develop and apply innovative in vitro model systems and analytical platforms, including microfluidic systems and advanced material-based platforms, to better understand product performance, biological responses, and safety-related outcomes. These studies will support identification of CQAs and product- or process-related factors that may influence therapeutic activity, toxicity, or other key outcomes.

• Develop expertise in cell and gene therapy product assessment:
  Gain hands‑on experience evaluating the safety, efficacy, and mechanistic behavior of AAV vectors and gene‑modified immune cells.
• Apply advanced experimental approaches:
  Learn to use gene modulation methods (for example, siRNA and CRISPR), cytokine profiling, flow cytometry, cytotoxicity assays, co‑culture systems, microfluidics, and biomaterial‑enabled model platforms.
• Investigate mechanisms underlying product performance and biological response:
  Study immune activation, inflammatory toxicities, immune‑cell interactions, and other determinants of therapeutic activity in physiologically relevant systems.
• Identify determinants of quality and function:
  Examine how product attributes and manufacturing‑related variables influence CQAs, therapeutic function, immune responses, and safety‑related endpoints.
• Integrate translational science with regulatory considerations:
  Build understanding of how mechanistic studies and innovative model systems inform regulatory science, product evaluation, and risk mitigation strategies for next‑generation therapies.
• Strengthen scientific communication and interdisciplinary collaboration skills:
  Present findings in internal and external scientific forums, contribute to peer‑reviewed publications, and collaborate with multidisciplinary teams across immunology, molecular biology, toxicology, bioengineering, and materials science.

The mentor for this opportunity is Nirjal Bhattarai (Nirjal.Bhattarai.gov). If you have questions about the nature of the research, please contact the mentor.

Fall 2026 or earlier. 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.