FDA Nonclinical Neural NAMs Fellowship

Oak Ridge Institute for Science and Education; Silver Spring (MD); On-site; USD 60,000 - 80,000; Full time

Job summary

Oak Ridge Institute for Science and Education (ORISE) offers a research fellowship with the Food and Drug Administration (FDA), CDER, in Silver Spring, Maryland, focusing on iPSC-derived neurons, astrocytes, and brain organoids to study drug effects and gene expression. Under a mentor, you will gain hands-on experience with cell culture, immunocytochemistry, confocal microscopy, and data analysis.

The appointment is full-time for two years, with a stipend commensurate with educational level and

Qualifications

• PhD in a relevant field.

Skills

Stem cell culture

Cell differentiation

3D cell models

Education

Doctoral degree

Job description

Application Deadline

11/6/2026 3:00:00 PM Eastern Time Zone

Description

• Applications will be reviewed on a rolling-basis.

FDA Office and Location

A research opportunity is available immediately with the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), located in Silver Spring, Maryland.

The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. These efforts cover more than just medicines.

Research Project

The FDA is committed to leveraging predictive new approach methodologies (NAMs) to advance the safety and efficacy assessment of therapeutic products. This fellowship research project centers on the use of human induced pluripotent stem cell (iPSC)-derived neurons, astrocytes, and brain organoids to investigate drug effects, receptor biology, and gene expression.

Learning Objectives

Under the guidance of a mentor, you will gain hands‑on experience with a range of techniques, including cell culture, immunocytochemistry, confocal microscopy, and gene manipulation, with a focus on comparing drug effects across monolayer and three-dimensional organoid systems. You will learn how applied regulatory research is designed at FDA, and information gathering necessary to understand data translation across in vitro, in vivo, and clinical (if available) contexts. You will be given opportunities to present research internally and externally, collaborate with the mentor and a team of multi‑disciplinary scientists to improve experimental design, execution, data analysis, and writing and oral presentation skills.

Mentor

The mentor for this opportunity is Wendy Wu ([e-mail]). If you have questions about the nature of the research, please contact the mentor.

Anticipated Appointment Start Date

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

Appointment Length

The appointment will initially be for 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 and Lawful Permanent Residents (LPR) only.

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.

Education

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

Preferred Skills

Experience with stem cell culture, differentiation, and 3D cell model generation

Point of Contact

Ashley

Eligibility Requirements

• Citizenship: LPR or U.S. Citizen
• Degree: Doctoral Degree.
• Discipline(s): Engineering
• Aerospace and Aeronautical
• Agricultural Engineering
• Architectural Engineering
• Bioengineering and Biomedical Engineering
• Biological/Biosystems Engineering
• Chemical Engineering
• Civil Engineering
• Communications Engineering
• Computer and Systems Engineering
• Electrical and Electronic Engineering (including Cybersecurity)
• Energy
• Engineering (General)
• Engineering Physics
• Engineering Sciences
• Environmental Engineering
• Geophysical Engineering
• Industrial Engineering
• Materials Science Engineering
• Mechanical Engineering
• Mechatronics, Robotics, and Automation Engineering
• Metallurgical Engineering
• Mining and Minerals Engineering
• Naval Architecture and Marine Engineering
• Nuclear Engineering
• Ocean Engineering
• Petroleum Engineering
• Polymer Engineering
• Radiation Protection
• Systems Engineering (including Human Systems)
• Life Health and Medical Sciences (51 )

Affirmation

I am a U.S. citizen, or I have lived in the United States for at least 36 out of the past 60 months. (36 months do not have to be consecutive.)

and

I have read the FDA Ethics Requirements.