FDA Postdoctoral Fellowship - Allergenic Products in Food Allergy and Therapy

Organization

U.S. Food and Drug Administration (FDA)

FDA-CBER-

10/9/2026 3:00:00 PM Eastern Time Zone

• Applications will be reviewed on a rolling-basis.

A research opportunity is currently available at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) located 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 will establish science-based approaches for immunological characterization of allergenic products and evaluation of food allergy immunotherapies. Through in vitro immunoassay development, analysis of immune responses to allergenic products, biomarker validation, and assessment of immunotherapy mechanisms, the project will generate evidence that supports risk assessment, product standardization, and regulatory decision-making for food allergy diagnostics and therapeutics. Currently, the lack of standardized immunological assays and validated biomarkers limits the ability to assess allergenic product consistency, predict immunotherapy outcomes, and evaluate safety and efficacy of emerging treatments.

This research aims to improve FDA-regulated product quality, safety, and efficacy for individuals with IgE-mediated food allergies requiring diagnostic or therapeutic intervention.

• Development of in vitro and in vivo assays for immunological evaluation of GRAS substances and allergenic excipients using animal food allergy models and animal surrogate technologies to assess immunogenicity and safety profiles.
• Development of modification-resolved IgE analysis methods to enhance allergenic product safety through improved allergenic product potency testing, enabling more accurate dose determination, establishment of clinical endpoints, and therapeutic monitoring of patient responses.
• Investigation of novel immunotherapy approaches for food allergy treatment, including mechanistic studies of immune cell engagers and chimeric allergen receptors designed to redirect immune responses and modulate allergic reactions.

These projects will generate data on excipient immunogenicity, IgE-based biomarkers, and innovative therapeutic mechanisms, supporting regulatory evaluation of food allergy diagnostics and treatments.

You will develop understanding of immunological principles underlying food allergy and allergenic product characterization. Through hands‑on laboratory experience, you will gain proficiency in advanced immunological assays including ELISA-based potency testing, modification-resolved IgE analysis, and cellular/tissue immunogenicity assessments using flow cytometry and super-resolution microscopy. You will learn to apply bioinformatic and statistical tools to analyze immunological datasets including DNA/RNA sequencing and mass spectrometry and interpret biomarker profiles.

Training will include structured mentorship, laboratory research, seminars, and engagement with FDA's scientific community. You will apply acquired knowledge to support regulatory science and gain communication skills through scholarly publications and scientific presentations. This experience offers valuable exposure to FDA operations.

The mentor for this opportunity is Alexander S. Zhovmer (Alexander.Zhovmer.gov). If you have questions about the nature of the research, please contact…