FDA Research Opportunity - Functional Antibody assays for Klebsiella

*Applications will be reviewed on a rolling-basis.

FDA Office and Location: A research opportunity is currently available at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) located 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: Multiple groups are developing vaccines that target Klebsiella pneumoniae which is a major cause of hospital-acquired infections and can manifest as pneumonia, bloodstream infections and surgical site infections. However, this bacterium is highly diverse and we anticipate that in vitro functional antibody assays will be needed to evaluate the effectiveness of Klebsiella vaccines against individual serotypes. Several functional antibody assays have been developed including opsonophagocytic antibody assays but not in a systematic fashion. In joining this project, you will learn to develop functional antibody assays (e.g., serum bactericidal antibody assays or opsonophagocytic antibody assays) that correlate with protection and which can be used for multiple capsular types, O serotypes and protein-based vaccines.

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

• Gain experience in bioassay development.
• Learn how to design and implement bioassays and subsequently analyze the data.
• Learn and become proficient at functional antibody assays including serum bactericidal antibody assays and opsonophagocytic antibody assays.
• Gain knowledge to support regulatory science, particularly as it relates to serological assays.
• Advance professional development in vaccine evaluation.

Mentor: The mentor for this opportunity is Sharon Tennant (Sharon.Tennant@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.

Anticipated Appointment Start Date: Summer 2026. 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.

Participant Stipend: The participant will receive a monthly stipend commensurate with educational level and experience. 

Citizenship Requirements: This opportunity is available to U.S. citizens and Lawful Permanent Residents (LPR) only.

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.