*Applications will be reviewed on a rolling-basis.

A research opportunity is currently available with the Office of the Commissioner (OC) Office of Women's Health (OWH), U.S. Food and Drug Administration (FDA). The project will be located at the Center for Drug Evaluation and Research (CDER) located in Silver Spring, Maryland.

The project will investigate the inflammatory signature of recurrent pregnancy loss. We have reported a novel mechanism whereby regulatory T cells lose their critical inhibitory function upon binding secretory IgA. This project will investigate whether secretory IgA could trigger immune-mediated pregnancy loss in a subset of patients. The larger question is the role of inflammation in recurrent pregnancy loss, whether secretory IgA driven or not. The project combines elements of cellular and molecular immunology with advanced statistical analysis, aiming to define a biomarker of tissue inflammation linked to increased pregnancy risk. This research may also suggest novel therapies to reduce and prevent recurrent pregnancy loss.

The participating fellow will be provided an educational experience fully exposing them to the research program of our laboratory. The fellow will learn about the scientific issues and rational of our research program, its relevance to FDA’s mission, as well as published and unpublished studies. The fellow will participate in daily research activities, setting up experiments, collecting data using various instruments, and analyzing data. The fellow will also learn about how to critically evaluate scientific papers, and will attend research seminars, lab meetings and scientific seminars and meetings. The fellow will also actively participate writing and editing scientific publications that result from this project.

If you have questions about the nature of the research, please reach out to the mentor, Dr. Mate Tolnay (mate.tolnay@fda.hhs.gov ).

Anticipated Appointment Start Date: 2023; 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 on-site for laboratory research 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 (OPM) 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.