FDA Fellowship – Functional Genomics of iPSC Maintenance and Cell Fate Determinations

Overview

*Applications will be reviewed on a rolling-basis.

FDA Office and Location: A research opportunity is currently available at the Center for Biologics Evaluation and Research (CBER), 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.

Research Project: This ORISE postdoctoral research project focuses on advancing the understanding of how intrinsic and environmental factors affect induced pluripotent stem cell (iPSC) maintenance and differentiation. The fellow will employ state-of-the-art cell engineering techniques to develop novel cellular models and hematopoietic differentiation methods for evaluating the safety and efficacy of advanced therapies. Additionally, the candidate will utilize molecular biology techniques to identify markers for investigating consistency of the differentiation process and heterogeneity of stem cell-derived cellular products.

Learning Objectives: By joining this research project you will have the opportunity to:

Develop skills in pluripotent stem cell expansion and differentiation.
Acquire knowledge in designing functional in vitro and in vivo assays for evaluating therapeutic products.
Apply molecular biology and analytical techniques to assess cellular heterogeneity.
Learn to acquire, summarize and report research data for scientific communication.
Gain regulatory science knowledge relevant to cellular and gene therapy products.
Mentor: The mentor for this opportunity is Zhaohui Ye (zhaohui.ye@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.

Anticipated Appointment Start Date: May 11, 2026.  Start date is flexible and will depend on a variety of factors.

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

Level of Participation: The appointment is full time.

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

Citizenship Requirements: 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 at FDA.  OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.

FDA Ethics Requirements

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 at FDA. For additional requirements, see FDA Ethics for Nonemployee Scientists.

FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency.  This agreement covers such topics as the following:

Non-employee nature of the ORISE appointment;
Prohibition on ORISE Fellows performing inherently governmental functions;
Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
The fact that research materials and laboratory notebooks are the property of the FDA;
ORISE fellow’s obligation to protect and not to further disclose or use non-public information.
Qualifications
The qualified candidate should have received a doctoral degree in one of the relevant fields (molecular & cell biology, genetics, immunology, bioengineering, or any related disciplines). The degree must have been received within 5 years of the appointment start date.

Preferred skills/ knowledge:

Demonstrated proficiency with pluripotent stem cells (ESCs and/or iPSCs), supported by primary authorship in peer-reviewed journal(s).
Experience in genetic modification methods such as programmable genome editing.
Excellent organizational skills.
Proficient with standard molecular biology methods including but not limited to cell culture, transfections, molecular cloning, immunoassays, and quantitative real-time PCR.
Familiarity with high throughput sequencing.
Creativity, self-motivation, and the ability to assimilate new information from multiple sources.