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 FDA Fellowship in Development and Characterization of a Phage Therapy to Decolonize Vancomycin-Resistant Enterococci

Center for Biologics Evaluation and Research (CBER), United States

Location:Silver Spring, MARYLAND

Deadline:31 Dec 2024

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

A research position is open at the Office of Vaccine Research and Review (OVRR) within the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) located in Silver Spring, Maryland.

A Postbaccalaureate Fellowship is available in the Carlson lab at the FDA, focusing on collaborative projects aimed at evaluating the effectiveness of bacteriophage therapies against Vancomycin-resistant Enterococcus species.

Project Description:

Since antibiotics were first introduced in the 1920s, they have played a crucial role in saving millions of lives by combating diseases like pneumonia, healthcare-associated infections, and foodborne illnesses. However, their widespread use has led to unintended consequences, including the disruption of beneficial gut bacteria and the emergence of antibiotic-resistant strains.

According to the Centers for Disease Control and Prevention (CDC), approximately 23,000 deaths in the United States each year are caused by infections from antibiotic-resistant bacteria, presenting a growing global challenge. Vancomycin-resistant enterococci (VRE), classified as a significant threat by the CDC, are responsible for around 20,000 infections annually in the U.S. The inability to effectively treat these infections with conventional antibiotics underscores the urgent need for alternative interventions.

The objective of this project is to develop and characterize a potent bacteriophage therapy targeting VRE, encompassing both vancomycin-resistant strains of E. faecalis and E. faecium. This endeavor involves establishing mouse models and evaluating bacteriophage efficacy and pharmacokinetics within this model framework.

Over the coming years, the project will primarily focus on identifying bacterial mutations that lead to resistance against bacteriophages and devising strategies to overcome such resistance, thereby laying the groundwork for successful therapeutic interventions. The exploration of bacteriophage therapy in this context is poised to have a significant impact on a relatively understudied area of research, offering promising avenues for addressing the challenge of antibiotic-resistant bacteria.

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.

Qualifications

The qualified candidate should be currently pursuing or have received a bachelor’s or master’s in the 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
  • Basic understanding of molecular biology/microbiological laboratory techniques

Eligibility Requirements

  • Citizenship: U.S. Citizen Only
  • Degree: Bachelor’s Degree or Master’s Degree received within the last 60 months or currently pursuing.
  • Discipline(s):
    • Chemistry and Materials Sciences (12 )
    • Engineering (27 )
    • Life Health and Medical Sciences (51 )

Affirmation

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.)

I have read the FDA Ethics Requirements.

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Last modified: February 10, 2024
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