FDA Review Chemist Fellowship

*Applications will be reviewed on a rolling-basis.

FDA Office and Location: A research opportunity is currently available at the U.S. Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN), Office of Dietary Supplement Programs (ODSP), located in College Park, Maryland. Opportunity may be remote.

Research Project: The participant will become a fellow to learn about being a review chemist in the Identity and Status Branch (ISB), of the Division of Research and Evaluation (DRE) in the Office of Dietary Supplement Programs (ODSP). The participant will research and review information (such as physical/chemical characteristics, manufacturing processes, analytical data, and scientific manuscripts) in support of determining the chemical identity and likely source (e.g., synthetic or natural) of an ingredient. The participant will also evaluate chemistry data and marketing data to help determine the regulatory status of an ingredient while working with ODSP review toxicologists to support safety review and determinations.

Learning Objectives: The ORISE participant will receive hands-on training from the mentor during the specified period. The participant will gain experience in:

• Understanding chemical characterization methods and test methods used to evaluate and characterize dietary ingredients and complex botanical mixtures.
• Performing comprehensive searches (e.g., peer reviewed publications; reports/studies from industry, governmental, intergovernmental and non-governmental organizations) to determine the source (natural vs synthetic) of chemical compounds.
• Reviewing chemical identification and marketing information to assist in the creating a list of dietary ingredients and establishing a priority ranking for a full review.
• Collaborating with laboratory researchers in identifying target analytes and for method development and validation.
• Helping in the preparation of reports and scientific manuscripts and presenting findings to scientific colleagues and stakeholders.

Anticipated Appointment Start Date: October 14, 2024.  Start date is flexible and will depend on a variety of factors.

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

Level of Participation: The appointment is full time.

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.