How To Apply

To submit your application, scroll to the bottom of this opportunity and click APPLY.

• An application
• Transcripts – Click here for detailed information about acceptable transcripts
• A current resume/CV, including academic history, employment history, relevant experiences, and publication list
• One educational or professional recommendation

All documents must be in English or include an official English translation.

For questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code (FDA‑CDER‑2026‑0074) in your email.

Organization

U.S. Food and Drug Administration (FDA)

Reference Code

FDA‑CDER‑2026‑0074

Application Deadline

9/30/2026 3:00:00 PM Eastern Time Zone

Job Description

The Center for Drug Evaluation and Research (CDER) in the Office of Pharmaceutical Quality Research (OPQR) invites applicants for a research fellowship in the Office of Pharmaceutical Quality at Silver Spring, Maryland.

Research Project

This project will research the glycan release from glycoprotein drugs with chemo‑enzymatic methods and characterize glycan structures with state‑of‑the‑art technologies, including H(U)PLC and mass spectrometry (MS).

Learning Objectives

Under the guidance of the mentor, you will learn state‑of‑the‑art technologies and develop novel technologies for the feasible analysis of glycosylation of therapeutic glycoprotein drugs, including monoclonal antibody (mAb) drugs, fusion proteins, enzyme‑replacement therapies, plasma products, etc., in manufacturing control and characterization.

Mentor

Tongzhong Ju (Tongzhong.Ju@fda.hhs.gov)

Appointment Dates

Anticipated start date: 2026 (start date is flexible). Appointment length: initial one year, may be renewed upon recommendation and contingent on funding.

Participation

Full‑time appointment. Monthly stipend commensurate with educational level and experience.

Citizenship Requirements

Open to U.S. citizens, Lawful Permanent Residents, and eligible foreign nationals. Non‑U.S. citizens must meet immigration status requirements as described on the program website.

Program Administration

The fellowship is administered by ORAU through a contract with the U.S. Department of Energy and a participation agreement with FDA. Participants are not employees of FDA, DOE or ORAU and receive no employment‑related benefits. Proof of health insurance is required.

Background Investigation

Successful completion of a background investigation by the Office of Personnel Management is required for the applicant to be onboarded. OPM investigations are available only to individuals who have resided in the U.S. for at least three of the past five years.

FDA Ethics Requirements

Orise Fellows and their families must disclose significant regulatory organization (SRO) or prohibited investment fund interests. Non‑diversified individuals are ineligible. Refer to FDA Ethics for Non‑employee Scientists for additional information.

Education Agreement

All Fellows must read and sign the FDA Education and Training Agreement within 30 days of the start date. The agreement outlines:

• Non‑employee nature of the ORISE appointment
• Prohibition on ORISE Fellows performing inherently governmental functions
• Obligation to convey all intellectual property rights on research conducted during the fellowship to the FDA
• Research materials and laboratory notebooks remain property of the FDA
• Obligation to protect and not disclose non‑public information

Qualifications

Doctoral degree in a relevant field earned within five years before the appointment start date, or a doctoral degree in progress to be completed before 9/29/2026.

Preferred Skills

Experience in mass spectrometry, glyco‑chemistry, proteomics, or related areas.

Point of Contact

Ashley

Eligibility Requirements

Doctoral degree received within the last 60 months or anticipated to be received by 9/30/2026. Disciplines include:

• Chemistry and Materials Sciences (Analytical Chemistry, Bio‑organic Chemistry, Biophysical Chemistry, General Chemistry, Organic Chemistry, Polymer Chemistry)
• Life, Health, and Medical Sciences

Affirmation

I have lived in the United States for at least 36 of the past 60 months (not required to be consecutive) and I have read the FDA Ethics Requirements.