US Food and Drug Administration
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FDA Postdoctoral Fellowships in Cell and Gene Therapy U.S. Food and Drug Administration (FDA) in United States
Degree Level
Postdoc
Field of study
Biomedical Engineering
Funding
Monthly stipend commensurate with educational level and experience; appointment initially for one year and may be renewed subject to recommendation and availability of funds.
Deadline
Nov 30, 2026
Country
United States
University
US Food and Drug Administration
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About this position
Two postdoctoral ORISE fellowships are available in the laboratory of Dr. Nirjal Bhattarai in the Office of Therapeutic Products at the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, in Silver Spring, Maryland. The project sits within a regulatory science environment focused on biologics, including cell and gene therapies, and aims to support the evaluation of next-generation therapeutic products.
The fellowship offers two related research directions. One focuses on cell and gene therapy safety, especially for AAV vectors, using mechanistic and translational laboratory studies to examine product quality attributes, immunogenicity, inflammatory toxicities, and process parameters that affect safety while maintaining performance. The second develops new approach methodologies (NAMs) for safety and efficacy assessment of gene therapy products and gene-modified immune cells, with emphasis on innovative in vitro systems, microfluidic approaches, and advanced material-based platforms to study product behavior and biological responses.
Under mentor guidance, the fellow will work with experimental systems relevant to immune activation, cytokine responses, cytotoxicity, and cell-cell interactions, and will help identify factors that shape therapeutic activity, toxicity, and other key outcomes. The role also includes integrating mechanistic research with regulatory considerations and contributing to scientific communication in multidisciplinary settings spanning immunology, molecular biology, toxicology, bioengineering, and materials science.
The opportunity is positioned for postdoctoral researchers interested in translational studies at the interface of therapeutic product assessment and regulatory science.
Funding details
Monthly stipend commensurate with educational level and experience; appointment initially for one year and may be renewed subject to recommendation and availability of funds.
What's required
Applicants should have received a doctoral degree in a relevant field such as bioengineering, biomedical engineering, chemical engineering, materials science, biological sciences, or a related discipline, and the degree must have been received within the past five years. The opportunity is available only to U.S. citizens and Lawful Permanent Residents. Preferred experience includes AAV gene therapy for the gene therapy project, or a strong background in microfluidics and materials science for the NAMs project; experience in cell and gene therapy, AAV biology, or immune cell engineering is also desirable. Strong collaborative skills and excellent written and oral communication skills are preferred. All documents must be in English or include an official English translation.
How to apply
Apply through the Zintellect opportunity page by scrolling to the bottom and clicking APPLY. Submit an application, transcripts, a current CV/resume, and two educational or professional recommendations. Indicate interest in Project Area 1, Project Area 2, or both in your cover letter; email [email protected] with questions and include the reference code.
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Prepare your application
Review drafts and confirm requirements with the university.
Make your next move.
Prepare your application
Review drafts and confirm requirements with the university.