*Applications will be reviewed on a rolling-basis, and this posting will remain open until filled.

A research opportunity is currently available in the Office of Blood Research and Reviews (OBRR) at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) in Silver Spring, Maryland.

Hepatitis A virus (HAV) causes acute hepatitis in humans. HAV is transmitted via the fecal-oral route, and infection is mainly due to ingestion of contaminated food and water or close contact with an infected individual. The ongoing HAV outbreak that started in 2016 in the US resulted in 43,648 cases, 26,627 hospitalizations, and 420 deaths as of January 14, 2022 (https://www.cdc.gov/hepatitis/outbreaks/2017March-HepatitisA.htm ). Parenteral transmission of HAV can also occur by blood and blood products, which poses a significant risk to the safety of the blood supply. HAV infects cells by hijacking the HAV cellular receptor 1 (HAVCR1), which has also been shown to be a cell entry factor for some enveloped viruses such as hepatitis C virus (HCV) and Ebola virus. Our laboratory is interested in pathogenesis of HAV and the role of HAVCR1 in hepatitis. 

The participant will train in classical virology, immunology, and molecular biology by characterizing hepatitis infection in clinical samples. The goal of the study is to advance our current understanding of factors that affect the severity of hepatitis, and the role of antibodies and immune cells in protection against the disease. We will use state-of-the art technologies to characterize viral load, liver enzyme elevations, induced cytokines, and role of per-existing antibodies in sterilizing immunity.  The participant will also study the role of HAVCR1 alleles in severity of hepatitis using molecular biology techniques and animal models. Some recent publications describing work performed in the laboratory that the participant may expand includes: Costafreda et al., Nature Microbiology 2020 (DOI:10.1038/s41564-020-0740-y); Kaplan et al., Nature Microbiology community 2020 (https://naturemicrobiologycommunity.nature.com/posts/viral-infection-by-exosome-mimicry-the-havcr1-npc1-pathway?channel_id=346-behind-the-paper ); Costafreda et al., Journal of Virology 2018 (DOI:10.1128/JVI.02065-17); and Tejada-Strop et al., JAMA Internal Medicine 2017 (10.1001/jamainternmed.2016.9057).

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 five months, 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. A health insurance allowance and a travel allowance will be provided. 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 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.