FDA Sunscreen Safety Fellowship

Organization
U.S. Food and Drug Administration (FDA)
Reference Code
FDA-CDER-2023-1317
How to Apply

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A complete application consists of:      

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.

Application Deadline
12/29/2023 3:00:00 PM Eastern Time Zone
Description

*Applications will be reviewed on a rolling-basis.

A research opportunity is available in the Office of New Drugs, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.

Sunscreen products contain UV-filters as active ingredients for the protection of skin against UV radiation. Dermal absorption data reveals systemic exposure of UV-filters in humans, which can be obtained from clinical maximal usage trials (MUsT). FDA guidance recommends conducting in vitro skin permeation tests (IVPT) to help select formulations for the clinical MUsT, as IVPT results may be indicative of in vivo absorption. We aim to develop sensitive and robust IVPT methods which are not available in the literature. In addition, different skin membranes will be used and the most appropriate model will be selected and validated. 

Under the guidance of a mentor, the participant will learn to develop and validate methodologies for safety and quality evaluation of sunscreen products. Correlations between the in vitro and in vivo performance of the sunscreen products will be investigated with the help of modeling and prediction software.

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 Silver Spring, 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 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 be currently pursuing or have received a master's or doctoral degree in one of the relevant fields (e.g. Pharmaceutical Sciences). Degree must have been received within five years of the appointment start date. 

Knowledge of or research experience in dermatology, transdermal/topical drug delivery, formulation, or cosmetic science is desirable.

Point of Contact
Eligibility Requirements
  • Degree: Master's Degree or Doctoral Degree received within the last 60 months or currently pursuing.
  • Discipline(s):
    • Chemistry and Materials Sciences (2 )
    • Engineering (2 )
    • Environmental and Marine Sciences (1 )
    • Life Health and Medical Sciences (45 )
    • Science & Engineering-related (1 )
Affirmation

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.)

I have read the FDA Ethics Requirements.

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