FDA Fellowship - Developing Novel Strategies to Safety, Efficacy and Quality of Gene

How to Apply

To submit your application, scroll to the bottom of this opportunity and click APPLY.

• An application
• Transcripts –  for detailed information about acceptable transcripts
• A current resume/CV, including academic history, employment history, relevant experiences, and publication list
• One educational or professional recommendation
• All documents must be in English or include an official English translation.

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

U.S. Food and Drug Administration (FDA)

FDA-CBER-

6/26/2026 3:00:00 PM Eastern Time Zone

• Applications will be reviewed on a rolling‑basis.

Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) in White Oak, Maryland.

AAV is a small viral vector commonly used for gene delivery, and AAV‑based gene therapies are beginning to show clinical successes. As the field rapidly expands, there is a need to develop innovative analytical methods and regulatory science approaches to comprehensively evaluate the safety, efficacy, and quality of these complex biological products. The project addresses gaps in our ability to assess AAV‑based gene therapy products by developing advanced in‑vitro models and analytical methodologies.

In joining, you will focus on two interconnected research areas:

• Development of three‑dimensional (3D) cell culture systems to evaluate AAV product potency and immunogenicity. 3D models better recapitulate complex tissue architecture, cell‑cell interactions, and microenvironmental conditions found in vivo, potentially providing more physiologically relevant data for regulatory decision‑making.
• Establishment of novel in‑vitro models for comprehensive safety and efficacy assessment, to evaluate product quality attributes, predict clinical outcomes, and identify potential safety concerns early in product development.

Gain practical experience in cutting‑edge fields of gene therapy and immunogenicity, learning methods including ELISpot assay, in‑vivo animal experiments, computational epitope analysis, and AAV purification and production. These methods can be utilized to study immunogenicity of proteins in many fields including drug and vaccine development or gene therapy.

Ronit Mazor (ronit.mazor.gov)

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.

Full‑time.

Monthly stipend commensurate with educational level and experience.

U.S. citizens and lawful permanent residents only.

FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of start. This agreement covers non‑employee nature, prohibition on performing inherently governmental functions, obligation to convey rights for intellectual property, property of research materials, and protection of non‑public information.

The qualified candidate should be currently pursuing or have received a doctoral degree in one of the relevant fields.

• Citizenship: LPR or U.S. Citizen.
• Degree:
  Doctoral Degree.
• Discipline(s):
  Life Health and Medical Sciences fields including (but not limited to) Agricultural Sciences, Agriculture, Agronomy and Crop Science, Anatomy, Animal Behavior, Animal Health and Food Safety, Animal Sciences, Basic Biomedical Sciences, Biochemistry, Bioinformatics, Biology (General), Biophysics, Botany, Cellular and Molecular Biology, Comparative Medicine and Laboratory Animal Medicine, Computational Biology, Developmental Biology, Ecology, Ecosystem Ecology, Emergency and Incident Management, Entomology, Environmental Health, Epidemiology, Evolutionary Biology, Food Sciences and Technology, Genetics and Genome Sciences, Health Physics, Horticulture, Immunology, Industrial Hygiene,…