FDA Fellowship - Immunogenicity of Protein Therapeutics

About the role

The FDA Fellowship in Immunogenicity of Protein Therapeutics offers training in cutting-edge technologies directly relevant to promoting public health. The research project involves optimizing Intravenous Immunoglobulin (IVIG) used in the treatment of neurological diseases.

Responsibilities

• Develop proficiency in orthogonal analytical methods (including lectin-based assays (SNA, ECL), lectin affinity chromatography, and LC-MS/MS glycan profiling) to enzymatically sialylate and rigorously characterize the Fc glycan profiles of commercial IVIG products across multiple manufacturers.
• Gain expertise in the mechanistic basis of IVIG anti-inflammatory activity, including hands-on experience with FcR binding and signaling assays using reporter cell lines, surface plasmon resonance (SPR), flow cytometry, and HEK 293-T co-expression systems to characterize FcRIIB and DC-SIGN co-engagement.
• Learn to design, develop, and qualify a cell-based potency assay, gaining direct experience in translating mechanistic biological insights into regulatory-grade analytical tools applicable to biologic product evaluation.
• Acquire skills in conducting and interpreting animal studies.
• Develop an understanding of the application of new approach methodologies (NAM) in biologic development.

Requirements

• Master's or doctoral degree in Biology, Pharmaceutical Science, Chemistry, Biochemistry, or Immunology received within the past 60 months or anticipated to be completed by June 30, 2026.
• Citizenship: U.S. Citizen or Legal Permanent Resident (LPR).

Qualifications

The qualified candidate should have received or be currently pursuing a master's or doctoral degree in one of the relevant fields (Biology, Pharmaceutical Science, Chemistry, Biochemistry, Immunology) within the past five years or be currently pursuing with completion by June 30, 2026.

Skills

Strong analytical skills, proficiency in laboratory techniques, and experience with Fc receptor biology and functional immunology are preferred.

Benefits

The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program.

Pay

The participant will receive a monthly stipend commensurate with educational level and experience.

Schedule

The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.