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FDA Fellowship in Assessing Safety and Efficacy of Antibody Therapies and Related Plasma-derived Products

*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 Tissues and Advanced Therapies (OTAT) at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) in Silver Spring, Maryland.

The research project is focused on assessing safety and efficacy of antibody-based biologic drugs. The participant will utilize mammalian and viral cell cultures (including Zika virus), live imaging, ELISA and other laboratory techniques to evaluate the potency of these preparations in vitro and in vivo. The participant will successfully complete all the institutional training for working safely with pathogens and/or animals and adhering to all the rules and regulations while performing their laboratory activities.

If selected, the fellow will gain in depth understanding of considerations in selecting appropriate models and endpoints to assess therapeutic potential of immune globulin preparations against existing and emerging viral diseases.

Anticipated Appointment Start Date: Spring 2022; 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. A health insurance allowance and a training allowance for scientific courses and conferences 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.