FDA Immunogenicity Risk Assessment Fellowship

Reference Code

FDA-CDER-

U.S. Food and Drug Administration (FDA)

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

Office of Product Quality Research, Center for Drug Evaluation and Research (CDER), Silver Spring, Maryland.

The project focuses on generating in silico, in vitro and in vivo strategies to assess product immunogenicity risk of proteins, oligonucleotides, and peptides. The study investigates how inflammation can increase the risk of anaphylactic or hypersensitivity reactions, cytokine release syndromes, loss of efficacy, and rare autoimmune or deficiency syndromes. The research will explore direct and indirect mechanisms, including the role of innate immune receptors, antigen‑presenting cells, mast cells and basophils, and the activation of B and T cell responses.

Under the guidance of the mentor, you will learn about innate immune response modifiers, become proficient in in vitro and in vivo modeling, apply state‑of‑the‑art technologies to analyze complex data, and engage in critical mechanistic thinking to become a mature scientist.

Mohanraj Manangeeswaran (Mohanraj.

Manangeeswaran.gov)

• Start date:
  
  flexible; announced within 2026
• Length: initially one year, may be renewed upon recommendation and funding availability
• Participation: full time
• Stipend: monthly stipend commensurate with educational level and experience

Open to U.S. citizens, Lawful Permanent Residents, and foreign nationals. Non‑U.S. citizen applicants should refer to the Guidelines for Non‑U.S. Citizens details page for applicable immigration statuses.

Applicants must meet background investigation criteria. Proof of health insurance is required. Participants do not become employees of FDA, DOE, or the program administrator, and there are no employment‑related benefits.

Applicants must read and sign the FDA Education and Training Agreement within 30 days of the start date, covering non‑employee appointment nature, prohibition of inherently governmental functions, obligation to convey rights to FDA, property of research materials, and confidentiality of non‑public information. They also must comply with FDA Ethics for Nonemployee Scientists regarding regulated financial interests.

• Master's or doctoral degree in Immunology, Pharmacology, or Immunopathology received within the last five years.

• Knowledge of animal models and design of experiments (DOE)

• Degree:
  Master’s or Doctoral received within 60 months.
• Discipline:
  Chemistry and Materials Sciences, Computer, Information, and Data Sciences, Engineering, or Life Health and Medical Sciences.

Ashley