FDA Postdoctoral Fellowship - Applied Regulatory Science Immunology

Organization

U.S. Food and Drug Administration (FDA)

FDA-CDER-

8/14/2026 3:00:00 PM Eastern Time Zone

Anticipated start date:
September 2026 (flexible). Appointment length: initially 1 year, may be renewed. Level of participation: full time. Participant stipend: monthly stipend commensurate with educational level and experience.

Food and Drug Administration – Center for Drug Evaluation and Research (CDER), Silver Spring, Maryland.

You will be involved in the immunogenicity testing of therapeutic protein drug products, including biosimilars and generics, that are of regulatory significance to CDER using in vitro techniques. In addition, novel approach methodologies (NAMs) for immunosafety assessment will be evaluated.

• Experimental design, testing and assessment of biologics, biosimilars and generics
• Multi-parameter flow cytometry
• ELISA (MSD & Luminex), ELISpot, cell isolation & culture
• Developing/testing of immunosafety NAMs
• Data analysis, literature review, and manuscript preparation

The fellowship will provide training in a range of immunological techniques that will be used to assess anti-drug antibody responses and other immunosafety issues.

Kristina Howard (kristina.howard.gov) – can be contacted for questions about the nature of the research.

• Currently pursuing or received a doctoral degree in a relevant field (biological sciences; emphasis in immunology, toxicology, and/or cell biology preferred).
• U.S. citizen or Lawful Permanent Resident (LPR) only.

• Citizenship: LPR or U.S. Citizen
• Degree:
  Doctoral Degree
• Discipline(s):
  Life Health and Medical Sciences (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, Genome Sciences, Health Physics, Horticulture, Immunology, Industrial Hygiene, Infectious Diseases and Zoonoses, Kinesiology and Exercise Physiology, Medicine, Microbiology, Neurosciences, Nursing, Nutritional Sciences, Occupational Health, Pharmacology, Pharmacy, Physiology, Plant Sciences, Population and Community Ecology, Population Medicine, Public Health, Structural Biology, Toxicology, Veterinary Sciences, Virology, Wildlife Sciences, Zoology (General)).

I am a U.S. citizen, or I have lived in the United States for at least 36 continuous months out of the past 60 months. I have read the FDA Ethics Requirements.

Applicants must submit a complete application with transcripts, resume/CV, educational or professional recommendation, and all documents in English or with official English translation. Background investigation is required. Participation is not an employment relationship with FDA, DOE, or the program administrator; no employment-related benefits.

Point of Contact:
Ashley. Email: ORISE.FDA.CDER (include reference code).