FDA CBER Postdoctoral Fellowship | Cell & Gene Therapy Research Opportunities

Interested in advancing cell and gene therapy research at a leading U.S. federal research agency? The FDA CBER postdoctoral fellowship offers two research opportunities at the U.S. Food and Drug Administration, focusing on gene therapy safety and innovative therapeutic assessment methods. This ORISE postdoctoral fellowship is open to eligible recent PhD graduates in chemical engineering, bioengineering, biomedical engineering, materials science, biological sciences, and related disciplines.

  • Position: Postdoctoral ORISE Fellow
  • Organisation: U.S. Food and Drug Administration (FDA)
  • Location: Silver Spring, Maryland, USA
  • Department: Office of Therapeutic Products (OTP), Centre for Biologics Evaluation and Research (CBER)
  • Number of Fellowships: 2
  • Research Areas: Cell and Gene Therapy Safety; New Approach Methodologies (NAMs)
  • Reference Code: FDA-CBER-2026-0016

About the FDA and Research Team

The U.S. Food and Drug Administration (FDA) operates under the Department of Health and Human Services. Its Centre for Biologics Evaluation and Research (CBER) regulates biological products, including vaccines, blood products, tissues, and cell and gene therapies. This Silver Spring, Maryland, fellowship is based in Dr Nirjal Bhattarai’s laboratory within the Office of Therapeutic Products, where research focuses on the safety, quality, and performance of advanced therapeutic products.

FDA CBER Postdoctoral Fellowship Description

The selected fellows will contribute to research investigating the safety and efficacy of cell and gene therapy products, including adeno-associated virus (AAV) vectors and gene-modified immune cells. This ORISE postdoctoral fellowship focuses on understanding how product characteristics, manufacturing parameters, and biological responses influence therapeutic performance and safety. Fellows will gain practical experience in advanced experimental methodologies, translational research, and regulatory science. The research opportunities are divided into two project areas.

Project Area 1: Cell and Gene Therapy Safety

  • This project focuses on improving the safety of gene therapy products, particularly AAV vectors. Researchers will investigate critical quality attributes (CQAs) that may influence immunogenicity, inflammatory toxicities, and other safety-related outcomes.
  • The fellow will use experimental model systems to identify manufacturing parameters associated with potential safety risks and develop strategies to reduce these risks while maintaining therapeutic performance.

Project Area 2: New Approach Methodologies (NAMs) for Cell and Gene Therapy

  • This project involves developing innovative experimental approaches to assess the safety and efficacy of gene therapy products, including AAV vectors and gene-modified immune cells.
  • The fellow will develop and apply advanced in vitro model systems, microfluidic technologies, and material-based analytical platforms to investigate biological responses, therapeutic activity, and toxicity.

Key Responsibilities

  • Evaluate the safety, efficacy, and mechanistic behaviour of AAV vectors and gene-modified immune cells.
  • Apply gene modulation techniques, including siRNA and CRISPR.
  • Perform cytokine profiling, flow cytometry, cytotoxicity assays, and co-culture experiments.
  • Develop and utilise microfluidic systems and biomaterial-enabled experimental platforms.
  • Investigate immune activation, inflammatory toxicities, and immune-cell interactions.
  • Examine how manufacturing variables and product characteristics influence critical quality attributes.
  • Study relationships between therapeutic performance, biological responses, and safety outcomes.
  • Integrate experimental findings with regulatory science and product evaluation.
  • Present research findings, contribute to peer-reviewed publications, and collaborate with multidisciplinary scientific teams.

Educational Requirements and Eligibility

Applicants interested in the FDA CBER postdoctoral fellowship must meet the following eligibility requirements:

  • Hold a doctoral degree in bioengineering, biomedical engineering, chemical engineering, materials science, biological sciences, or a related discipline.
  • Have received their doctoral degree within the past five years.
  • Be a U.S. citizen or Lawful Permanent Resident (LPR).
  • Successfully complete the required background investigation before onboarding.
  • Demonstrate relevant research knowledge and the ability to collaborate with scientific teams.
  • Applicants may indicate their interest in Project Area 1, Project Area 2, or both in their cover letter.

Preferred Skills and Qualifications

Candidates applying for this Silver Spring, Maryland, fellowship should possess research experience relevant to either project area.

For Cell and Gene Therapy Safety:

  • Experience in AAV-based gene therapy research.
  • Knowledge of gene therapy product safety and biological responses.
  • Understanding of immunogenicity, inflammatory mechanisms, and related experimental techniques.
  • For New Approach Methodologies:
  • Strong background in microfluidics and materials science.
  • Experience in cell and gene therapy research.
  • Familiarity with AAV biology or immune cell engineering.
  • Knowledge of advanced in vitro model systems and analytical platforms.
  • Applicants should also demonstrate strong collaboration skills and excellent written and oral scientific communication abilities.

Fellowship Stipend and Appointment Details

Participants selected for the FDA CBER postdoctoral fellowship will receive a monthly stipend commensurate with their educational qualifications and experience. The exact stipend amount has not been specified.

  • Appointment Duration: Initially one year, with possible renewal subject to FDA recommendation and funding availability.
  • Work Schedule: Full-time.
  • Anticipated Start Date: Fall 2026 or earlier, depending on circumstances.
  • Health Insurance: Proof of health insurance is required.
  • Employment Status: Fellows are not considered employees of FDA, DOE, or the program administrator and do not receive employment-related benefits.

Application Details:

  • Application Deadline: November 30, 2026, at 3:00 PM Eastern Time.
  • Application Review: Rolling basis.
  • Reference Code: FDA-CBER-2026-0016

Required Application Documents:

  • Completed online application.
  • Academic transcripts.
  • Updated resume or CV, including academic history, employment history, relevant experience, and publications.
  • Two educational or professional recommendations.
  • Cover letter indicating interest in Project Area 1, Project Area 2, or both.
  • All application documents must be submitted in English or accompanied by an official English translation.
  • For application-related inquiries, contact [email protected] and mention the fellowship reference code.
  • For research-related questions, contact Dr Nirjal Bhattarai at [email protected].

Interested in contributing to advanced cell and gene therapy research? The FDA CBER postdoctoral fellowship offers recent PhD graduates an opportunity to develop specialized skills in gene therapy safety, bioengineering, and regulatory science. This ORISE postdoctoral fellowship combines practical research experience with interdisciplinary collaboration. Eligible candidates should prepare their applications and submit the required documents before November 30, 2026.

APPLY ONLINE HERE