*Applications will be reviewed on a rolling-basis.
FDA Office and Location: A research opportunity is currently available at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA). in White Oak, Maryland.
The Center for Biologics Evaluation and Research (CBER) is one Center within the Food and Drug Administration, an Agency within the United States Government's Department of Health and Human Services. CBER's mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies.
The ORISE Research Participation Program at the U.S. Food and Drug Administration is an educational and training program designed to provide college students, recent graduates, and university faculty opportunities to connect with the unique resources of the FDA. With the support of an assigned mentor, participants have authentic hands-on research experience and allows them access to unique research opportunities, top scientists and engineers, and state-of the art facilities and equipment.
Research Project: This research project focuses on detection of emerging and re-emerging transfusion-transmissible viruses (specifically hepatitis viruses) that threaten the safety of blood and blood-derived products. The project aims to advance in vitro models of infection and in vivo models of transfusion transmission. These models will be used to:
Learning Objectives: You will learn principles of blood safety and methods for detecting emerging and re-emerging bloodborne viruses. You will use multidisciplinary approaches to analyze biomarkers of virus infections using in vitro and in vivo models of infection and samples from human subjects (both symptomatic and asymptomatic individuals with virus infections). You will receive laboratory-based training in molecular virology and cell biology methods including virus propagation in cell culture, virus detection and quantitation by RT-qPCR or digital droplet PCR, infectivity assays, virus purification and biochemical characterization, virus nucleic acid sequence analysis, protein expression, and ELISA. You will develop your communication skills by presenting your research in scientific seminars. You will have opportunities to attend scientific seminars and trainings to learn about state-of-the-art technology in pathogen detection.
Mentor: The mentor for this opportunity is David McGivern (David.McGivern@fda.hhs.gov ). If you have questions about the nature of the research, please contact the mentor.
Anticipated Appointment Start Date: July 2026. 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.
Participant Stipend: The participant will receive a monthly stipend commensurate with educational level and experience.
Citizenship Requirements: This opportunity is available to U.S. citizens and Lawful Permanent Residents (LPR) only.
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.
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