FDA Fellowship - Immunogenicity of Gene Editors

Organization

U.S. Food and Drug Administration (FDA)

FDA-CBER-

6/19/2026 3:00:00 PM Eastern Time Zone

Applications will be reviewed on a rolling basis.

A research opportunity is available in the Division of Plasma Protein Therapeutics (DPPT), Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) in Silver Spring, Maryland. The Center for Biologics Evaluation and Research (CBER) is one Center within the Food and Drug Administration, an Agency within the United States Government's Department of Health and Human Services.

CBER's mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies.

You will join a research program that broadly investigates unwanted immune responses to proteins used in therapeutic applications. The specific focus will be immune responses to Cas proteins used in gene editing. Cas9 proteins derived from human pathogens are the most extensively studied CRISPR-Cas gene editors. An important hurdle when developing and licensing a protein for clinical applications is the potential for immune responses to the protein.

We have previously demonstrated both T- and B-cell immunity to diverse Cas proteins. You will help identify promiscuous immunogenic epitopes in emerging Cas proteins and develop new tools to understand the safety consequences of immune responses to neo‑epitopes generated due to off‑target gene editing.

Under the guidance of a mentor, you will receive training in cutting edge technologies directly relevant to promoting public health, opportunities to attend seminars and formal training programs. You will participate in collaborative projects with academia and/or industry and will thus be well positioned for diverse career options after the training period. Flexibility and a willingness to learn new techniques is a desirable quality in the applicant.

Zuben

E. Sauna (zuben.sauna.gov)

2026. Start date is flexible and will depend on a variety of factors.

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

The appointment is full time.

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

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.

This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. 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 on‑boarded  can complete a background investigation only for individuals, including non‑U.S. citizens, who have resided in the U.S. for a total of three of the past five years.

If an ORISE Fellow, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed  additional…