FDA Postdoctoral Fellowship - Biopredictive Dissolution Development Oral Peptides

Research Project

Oral peptide drug products present unique scientific challenges because conventional quality control (QC) dissolution methods may not adequately capture the complex interplay among dosage form disintegration, peptide release, and gastrointestinal physiology that governs in vivo performance. The inclusion of permeability enhancers in products such as Wegovy further complicates the development of biopredictive dissolution methods. Such methods are important for informing bioequivalence assessments during lifecycle management – including bridging different products throughout development or implementing post‑approval changes – and for supporting generic drug development.

• Evaluating formulation and process variables that influence dissolution behavior;
• Contributing to the development and assessment of discriminating and physiologically relevant dissolution methods;
• Exploring relationships between in vitro dissolution behavior and in vivo absorption‑relevant processes;
• Applying advanced analytical approaches to characterize peptide release and performance;
• Contributing to evidence generation that supports scientifically sound frameworks for biopredictive dissolution method development.

Under the guidance of senior scientist mentors, you will be engaged in pharmaceutics and regulatory science research, gaining hands‑on experience in dissolution method development, analytical characterization, experimental design, and mechanistic interpretation of oral peptide performance. Your training will include exposure to advanced dissolution methodologies, principles aligned with ICH Q14 analytical development concepts, and approaches for linking in vitro data to in vivo performance attributes.

Additional educational opportunities include participation in scientific seminars, interdisciplinary discussions, and collaborative research activities related to complex drug product evaluation.

The qualified candidate should be currently pursuing or have received a doctoral degree in one of the relevant fields.

• Strong analytical capability.
• Pharmacy/pharmacology related knowledge is preferred.

Hailing Zhang (hailing.zhang.gov).

Anticipated appointment start date:
September 1, 2026. Start date is flexible and will depend on a variety of factors.

Appointment length: initially one year, may be renewed upon recommendation of FDA and is contingent on the availability of funds.

Level of participation: full time.

The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. Participants do not become employees of FDA, DOE, or the program administrator, and there are no employment-related benefits. Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be onboarded at FDA.

This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non‑U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.