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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.

FDA Office and Location: A research opportunity is currently available in the Office of Vaccines 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: A training opportunity is available for studying of humoral immune responses following, RSV or influenza infections and vaccination in humans as well as novel vaccine adjuvants and mucosal vaccines. The participant will be trained in advanced techniques developed in the lab including virus neutralization assays, cytokine production; whole genome gene-fragment phage display libraries (GFPDL); Surface Plasmon Resonance (SPR); recombinant protein expression in bacterial and mammalian systems. The appointment will include training on mode of action and safety of novel adjuvants used to enhance immune responses to multiple vaccines using human derived cells and organoids such as monocytes/macrophages, bronchio-epithelial and nasal-epithelial cells grown under Air-Liquid-Interphase (ALI).

Learning Objectives: Under the guidance of a mentor, you will: 

• Develop understanding of human infectious diseases with emphasis on respiratory viruses pathogenesis, immune responses, and correlates of protection,
• Learn to apply multiple analytical assays to questions related to vaccine safety and efficacy
• Gain experience in multiple techniques including multiplex assays, virus neutralization, Plasmon Surface Resonance machines, protein production, and more
• Learn skills in data analysis software including statistical software, protein modeling, and AI assisted analysis.
• Develop skills in scientific presentations both at the Lab and Division levels and in scientific meetings

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.

Applicants should have received a bachelor's, master's, or doctoral degree in one of the relevant fields. Degree must have been received within the past three years.

• Degree: Bachelor's Degree, Master's Degree, or Doctoral Degree received within the last 36 month(s).
• Discipline(s):
  • Life Health and Medical Sciences (3 )

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.