FDA Postdoctoral Fellowship to Investigate the Immunogenicity of Gene Therapy Products

Overview

*Applications will be reviewed on a rolling-basis.

FDA Office and Location: A research opportunity is currently available at the Office of Therapeutic Products (OTP), 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: AAV is a small viral vector commonly used for gene delivery. AAV based gene therapies are beginning to show clinical successes. However, due to the viral origin of AAV, there is a growing body of evidence demonstrating interactions of AAV vectors with the innate and adaptive immune system which hinder their successful translation from the bench to the bedside. Our lab’s goal is to develop technologies to help evaluate and mitigate the adaptive immunogenicity of AAV vectors in gene therapy. The successful candidate will learn about developing approaches for immune mitigation by rational design and by immune tolerance induction and will eventually test these approaches in mice models.

Learning Objectives: The fellow will be in a highly translational and collaborative environment and learn techniques including AAV production and quantification, cloning, screening techniques and humoral and cellular immunological assays.

Anticipated Appointment Start Date: September 10, 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 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.
Qualifications
The qualified candidate should be currently pursuing or have received a master’s or doctoral degree in the one of the relevant fields. Degree must have been received within the past five years, or be currently pursuing.

Preferred skills:

Experience in the purification and characterization of proteins in mammalian systems.
Experience in production and purification of viral vectors.
Recombinant DNA techniques.
Excellent tissue culture techniques.
Experience with computational HLA binding, structural biology and protein design.
Immunological assays including flow cytometry, measuring T-cell mediated immune responses, ELISpot, ADA, Nab and ELISA.
In vivo mouse work.
Self motivation and willingness to learn new technologies and methods are critical.