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US Food and Drug Administration

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FDA Determination of Qualification Limits for Peptide-related Impurities of Follow-on Products to Inform Guidance U.S. Food and Drug Administration (FDA) in United States

Degree Level

Master's

Field of study

Chemistry

Funding

Monthly stipend commensurate with educational level and experience; renewable for one year initially, contingent on availability of funds.

Deadline

Jan 1, 2027

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Country

United States

University

US Food and Drug Administration

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Keywords

Chemistry
Biology
Medical Science
Regulatory Biology
Pharmacy
Salud Pública
Drug Safety
Immunity
Pharmacokinetic
Peptidomic
Pharmacodynamic

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About this position

This research opportunity is based within the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) at White Oak, Maryland. The project sits at the intersection of regulatory science, drug quality, and immunology, with a focus on how peptide- and protein-related impurities in follow-on therapeutics may influence immunogenicity risk.

The work will investigate immunogenicity-based qualification thresholds for impurities in follow-on peptide and protein products. A key goal is to better understand how sequence variants and process- or product-related impurities can generate immune responses that may affect product safety and performance. The research is designed to help close a regulatory gap by connecting analytical impurity assessment with mechanistic evidence on immune activation.

Under mentor Sujin Hwang, the participant will gain hands-on experience with studies aimed at identifying impurity-derived neoepitopes, defining T-cell activation thresholds, and characterizing HLA-restricted mechanisms of drug-specific immune responses. The project also includes translational evaluation using humanized HLA mouse models, supporting a stronger link between laboratory findings and potential in vivo relevance.

The broader environment is FDA CDER, where research directly supports the agency’s public health mission to ensure safe and effective drugs for people in the United States. The opportunity is framed around regulatory uncertainty for follow-on peptide and protein therapeutics and seeks evidence that can inform future FDA guidance.

Funding details

Monthly stipend commensurate with educational level and experience; renewable for one year initially, contingent on availability of funds.

What's required

The qualified candidate should have received or be currently pursuing a master's or doctoral degree in a relevant field. The opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals who meet the program's acceptable immigration status requirements. Applicants must provide transcripts, a current resume/CV, and one educational or professional recommendation, all in English or with official English translations. Proof of health insurance is required, and completion of a successful background investigation is required for onboarding at FDA; OPM background investigations can be completed only for individuals who have resided in the United States for a total of three of the past five years.

How to apply

Submit the application through the Zintellect page by scrolling to the bottom of the opportunity and clicking APPLY. Include the application form, transcripts, current CV/resume, and one recommendation. If you have questions, email [email protected] and include the reference code FDA-CDER-2026-0192.

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