FDA Fellowship - Immune Globulin Safety and Efficacy in Pregnant and Neonatal Populations

*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: Our research aims to test microphysiological systems (MPS) for evaluating the exposure and therapeutic activity of anti-viral antibody preparations. In this project we are using a lung MPS that includes both vasculature and lung or placenta tissues as a platform for in vitro functional potency assays. We assess biodistribution and functional potency of monoclonal and polyclonal antibodies against respiratory syncytial virus (RSV) in the presence and absence of the RSV infection. This study would serve as proof of concept for the utility of MPS-based potency assays in assessing antibody products.

Learning Objectives: If selected, you will learn how to:

• Handle pathogens safely, adhering to all the laboratory and personnel safety rules and regulations during appointment activities;
• Effectively communicate research findings using poster/oral presentations, and written communications;
• Become an active part of a dynamic, diverse and results-oriented team;
• Gain a deeper understanding of appropriate models and endpoints that can be used assess therapeutic potential of antibody products against viral diseases.

Mentor: The mentor for this opportunity is Evi Struble (evi.struble@fda.hhs.gov ). If you have questions about the nature of the research, please contact the mentor.

Anticipated Appointment Start Date: 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.