A complete application consists of:
All documents must be in English or include an official English translation.
If you have questions, send an email to ORISE.FDA.CBER@orau.org. Please include the reference code for this opportunity in your email.
*Applications will be reviewed on a rolling-basis.
A research opportunity is currently available with the Division of Plasma Protein Therapeutics (DPPT), in the Office of Tissues and Advanced Therapies (OTAT), at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) located in Silver Spring, Maryland.
The selected participant will join a research program that studies methods to detect neutralizing antibody activity in serum or plasma against viruses, and the effect of neutralizing antibodies in commercially produced Immune Globulin therapies in animal models. The current efforts of the laboratory are focused upon development of a BSL-2 method to reliably measure neutralizing antibody activity against SARS-CoV-2 in convalescent plasma, to provide a safe and fast method for selection of high-titer donations for COVID-19 therapy. The research team has already developed and tested a similar assay for H1N1 influenza antibodies.
Under the guidance of a mentor, learning objectives for the participant during this appointment include:
The participant will conduct research in close association with experimental biologists in developing and optimizing the SPR neutralization assay for convalescent human serum/plasma, and animal serum (from animals immunized against SARS-CoV-2).
Anticipated Appointment Start Date: July 1, 2020
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 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:
The qualified candidate should have received a master's or doctoral degree in one of the relevant fields, or be currently pursuing one of the degrees and will reach completion by the appointment start date. Degree must have been received within five years of the appointment start date.
Preferred skills:
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