FDA Nonclinical Neural NAMs Fellowship
To submit your application, scroll to the bottom of this opportunity and click APPLY.
A complete application consists of:
- 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.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.
*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 (wendy.wu@fda.hhs.gov). 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.
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
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.)
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