FDA Determination of Qualification Limits for Peptide-related Impurities of Follow-on Products to Inform Guidance

About the role

The project aims to establish Immunogenicity-Based Qualification Thresholds for Peptide and Protein Impurities and assess HLA-Restricted T-Cell and Anti-Drug Antibody Risk.

Responsibilities

• Establish advanced analytical methods to detect and quantify peptide and protein impurities contributing to immunogenicity risk.
• Conduct stressed and accelerated stability studies to generate peptide and protein drug-related impurities for in vivo, in vitro analytical/immunogenicity assays.
• Establish and optimize MHC-associated peptide proteomics (MAPPs) methods to elucidate HLA-restricted mechanisms of drug-specific T-cell responses.
• Gain experience in immunogenicity and advanced analytics in collaboration with a multi-disciplinary research team.

Requirements

The ideal candidate should have received or be currently pursuing a master's or doctoral degree in relevant fields, preferably in Chemistry and Materials Sciences.

Qualifications

• Master's Degree or Doctoral Degree received within the last 60 months or anticipated to be received by 12/31/2026.
• Experience in proteomics and/or MAPPs assays for immunogenicity.

Skills

Preferred skills include experience in proteomics and/or MAPPs assays for immunogenicity.

Benefits

No specific benefits are mentioned in the job posting.

Pay

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

Schedule

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