FDA Postdoctoral Fellowship on Investigation of Sex Difference in Immunogenicity and Efficacy of AAV-Mediated Gene Therapy

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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.CDRH@orau.org. Please include the reference code for this opportunity in your email.

*Applications will be reviewed on a rolling-basis. 

A research opportunity is currently available with the Office of the Commissioner (OC) Office of Women's Health (OWH), U.S. Food and Drug Administration (FDA).  The project will be located at the Center for Biologics Evaluation and Research (CBER) Food and Drug Administration (FDA) Mazor laboratory located in Silver Spring, Maryland. 

The project will include in vitro and in vivo investigation of the differences between males and females and their innate and adaptive immune response to gene therapy products. The research participant will learn novel methods in gene therapy vector production and research the highly translational field of immunogenicity of gene therapy products.  

Anticipated Appointment Start Date: October 1, 2023; start date is flexible.

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 on-site for laboratory research 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 (OPM) 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 doctoral degree in one of the relevant fields. Degree must have been received within the past five years.

Preferred experience/skills include:

• Immunological assays including flow cytometry, measuring T-cell mediated immune responses, ELISpot and ELISA, TLR reporter assays
• Experience in the purification and characterization of proteins in mammalian systems
• Excellent tissue culture techniques 
• Knowledge of In vivo mouse procedures (handling, injections, bleeding, organ isolation, etc.)
• Basic recombinant DNA techniques
• Willingness to learn new technologies and methods

Must meet security requirements including a minimum of 3 out of the past 5 years with residency status in the US.

• Degree: Doctoral Degree received within the last 60 months or anticipated to be received by 10/2/2023 11:59:00 PM.
• Academic Level(s): Graduate Students or Postdoctoral.
• Discipline(s):
  • Engineering (3 )
  • Life Health and Medical Sciences (13 )

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.