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A complete application consists of:      

• An application
• Transcripts – Click here for detailed information about acceptable transcripts
• A current resume/CV, including academic history, employment history, relevant experiences, and publication list
• One educational or professional recommendation

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 in the Office of Vaccines Research and Reviews (OVRR) at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) in Silver Spring, Maryland.

The selected participant will be involved in an exciting research program applicable to the area of viral vaccines against the novel coronavirus. The primary technique to be utilized is small animal immunization and challenge studies.

The primary learning objective is to understand the aspects regarding vaccine safety and efficacy that are both critical to regulatory review. Through learning how to design a vaccine challenge experiment and how to execute as well as data analysis, we expect to provide a whole picture to the trainee what are the important aspects to look at during vaccine research. The participant will also learn many technical skills during the training, including animal model selection guided by intelligence, molecular virology, immunophenotyping, histopathology, evaluation of immune markers by molecular assays.

Anticipated Appointment Start Date: August 1, 2021; 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. 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.

The qualified candidate should have received a doctoral degree in one of the relevant fields. Degree must have been received within the past five years.

Preferred skills:

• Outstanding publication record of research productivity
• Exceptional written and oral communication skills
• Experience in scientific critique
• Broad knowledge related to molecular virology, immunology of viral diseases, or pathogenesis of RNA viruses with direct relevance to the development and evaluation of new viral vaccines
• Technically advanced, capable of driving a research project, and have experience with handling small animals
• Experience in animal models of SARS-CoV-2 or influenza viruses in the ABSL-3 environment

• Citizenship: LPR or U.S. Citizen
• Degree: Doctoral Degree received within the last 60 month(s).
• Discipline(s):
  • Life Health and Medical Sciences (46 )

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.)