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A complete application consists of:

• An application
• 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.

FDA Office and Location: A research opportunity is currently available in the Office of Vaccine Research and Review (OVRR) at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) in Silver Spring, 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.

Research Project: CBER is a unique environment in which to conduct research related to the development of new biomedical products, including new vaccines. Within CBER, our laboratory is interested in the nature of protective immunity to intracellular bacteria, including Mycobacterium tuberculosis and Francisella tularensis. The participant selected for this opportunity will join current projects related to M. tuberculosis, which revolve around using animal models to define protective immune mechanisms, understand host genetic control of protection, and develop vaccine-induced correlates of protection (for more information about the lab’s research, please see recent publications via http://www.ncbi.nlm.nih.gov/sites/myncbi/1LiW9NRGRNgQa/bibliography/47968487/public/?sort=date&direction=descending).

Learning Objectives: The fellow will learn the principals of experimental design and analyses; fundamentals of immunology and immunological assays; and fundamentals of microbiology and infectious disease animal models.

Anticipated Appointment Start Date: 2024. 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.

Citizenship Requirements: This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.

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.

The qualified candidate should have received a bachelor's or master's degree in one of the relevant fields or currently pursuing the degree with an expected graduation date before May 31, 2024. Degree must have been received within the past five years.

Preferred skills:

• Recent M.S. degrees or B.S. degrees with applicable experience will be considered.
• Bench research experience related to the laboratory; intelligence, independence, and initiative; and excellent organizational, writing, and interpersonal skills are a plus.
• Particular consideration will be given to candidates who have experience with sterile tissue culture, cellular immunology, BSL-3 procedures, and/or mouse infection models.

• Degree: Bachelor's Degree or Master's Degree received within the last 60 months or anticipated to be received by 5/31/2024 11:59:00 PM.
• Academic Level(s): Post-Bachelor's or Post-Master's.
• Discipline(s):
  • Life Health and Medical Sciences

I have lived in the United States for at least 36 out of the past 60 months. (36 months do not have to be consecutive.)
and
I have read the FDA Ethics Requirements.

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!