FDA Postbac Fellow in Microbiome and Infectious Disease

*Applications will be reviewed on a rolling-basis, and this opportunity will remain open until filled.

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.

A post-baccalaureate position is immediately available in the laboratory of Dr. Paul Carlson at the United States Food and Drug Administration in Silver Spring, Maryland. The postbac fellow will perform experiments under the supervision of the Principal Investigator and a postdoctoral fellow. These projects are designed to understand key regulatory questions regarding safety, manufacturing, and efficacy of fecal transplantation (FMT) and live biotherapeutic products (LBPs) using next generations sequencing and various animal models. The FMT projects will initially focus on Clostridioides difficile infections, but will be expanded to other microbiome related diseases in the near future. LBP projects focus on the development of assays for assessment and characterization of multi-strain products. The fellow will receive training in microbiology and basic bioinformatic methods used to assess the microbiota.

Anticipated Appointment Start Date: August 1st, 2024

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 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 in one of the relevant fields or be currently pursuing the degree with completion expected prior to the start of the appointment. Degree must have been received within the past five years.

Preferred skills:

• An interest in microbiology, bacteriology, the microbiome, and/or infectious disease takes priority
• Basic understanding of molecular biology/microbiological laboratory techniques

The application must be completed through Zintellect. https://www.zintellect.com/Opportunity/Details/FDA-CBER-2024-03