Overview

*Applications will be reviewed on a rolling-basis.

Two research opportunities are 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.

The participant will participate as review toxicologist in the Safety Evaluation Branch (SEB), of the Division of Research and Evaluation (DRE) in the Office of Dietary Supplement Programs (ODSP). Will support ODSP review toxicologists, by identifying, researching and evaluating in vitro, in vivo and clinical results, and other safety data and information that pertain to the safety of chemicals used in dietary supplements. Assists review toxicologists in establishing protocols and procedures for prioritizing, based on preliminary assessments, the review of ingredients. Assists in establishing procedures for determining if/when meta-analyses or systematic reviews are warranted and coordinating and participating in these reviews. The participant will interact with Office of Food Additive Safety to learn how the review process for food ingredients and dietary supplement ingredients compare and with the Office of Outreach and Analytics an understanding of risk assessment approaches and practices.

Anticipated Appointment Start Date: As soon as a qualified candidate is identified; start date is flexible

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 initial appointment is for one year but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. The appointment is full-time at FDA in the College Park, Maryland, area. 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 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 (e.g. Toxicology). Degree must have been received within five years of the appointment start date.

Candidates who have received a doctoral degree in an appropriate discipline of the Biological, Medical, or Veterinary Sciences that included at least 30 semester hours in Chemistry, Biochemistry, or Physiology, and 12 semester hours in Toxicology are encouraged to apply.

Preferred skills/experience in:

– Training or experience with the toxicology of ingested products (e.g., food or dietary supplements) or related in vitro or in vivo toxicology
– Experience in literature/database searching for toxicology information such as ADME, pharmacokinetics, carcinogenesis, pathology, target organ effects, and threshold effects (e.g., LOAEL)
– Research and manuscript preparation experience