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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, and this opportunity will remain open until filled.
A research opportunity is available in the Office of Tissues and Advanced Therapies (OTAT), Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) in Silver Spring, Maryland.
The 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 work of the laboratory is 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.
The candidate 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).
Under the guidance of a mentor, the selected candidate will be involved in, but not limited to, the following activities:
Anticipated Appointment Start Date: First half of 2023; 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 three to four 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. 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 (e.g. Virology, Biology, Molecular Biology, Structural Biology, Immunology, Chemistry, Biophysics, Physics), or be currently pursuing one of the degrees with completion before prior to the start of the appointment. Degree must have been received within the past five years.
Preferred Skills:
Have you lived in the United States for at least 36 out of the past 60 months? (36 months do not have to be consecutive.)
Will your degree be received prior to the start of your appointment?
ORISE GO
The ORISE GO mobile app helps you stay engaged, connected and informed during your ORISE experience – from application, to offer, through your appointment and even as an ORISE alum!
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