FDA Immunogenicity of Therapeutic Proteins Fellowship

Organization
U.S. Food and Drug Administration (FDA)
Reference Code
FDA-CBER-2021-0002
How to Apply

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A complete application consists of:      

All documents must be in English or include an official English translation.

If you have questions, send an email to ORISE.FDA.CBER@orau.org. Please include the reference code for this opportunity in your email.

Application Deadline
5/31/2021 3:00:00 PM Eastern Time Zone
Description

*Applications will be reviewed on a rolling-basis.

A postdoctoral research opportunity is currently available in the Division of Plasma Protein Therapeutics (DPPT), within the Office of Tissues and Advanced Therapies (OTAT), at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) in Silver Spring, Maryland.

For this research project, the participant will join a research program that broadly studies the immune responses to therapeutic proteins (immunogenicity). They will collaborate with experimental biologists and immunologists as well as clinicians to identify genetic risk factors for immunogenicity. The following articles in the literature provide examples of the range of work performed in our group:

  • Front. Immunol. 10: 2894, 2019
  • Blood Adv. 3: 2668-2678, 2019
  • AAPS J. 21: 96, 2019
  • Blood Adv. 3: 1429-1440, 2019
  • Mol Ther Methods Clin Dev. 10: 105-112, 2018
  • Sci. Transl. Med. 9: eaag1286, 2017
  • Blood 125: 223-228, 2015
  • Nature Med. 19: 1318-1324, 2013
  • PLoS Comput. Biol., 9, e1003066, 2013
  • Nature Biotechnol. 29: 870-873, 2011

Anticipated Appointment Start Date: January 1, 2021

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 four months, 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 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 have received a master's or doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date. 

Preferred skills:

  • Experience in computational biology and/or statistics
  • Experience using R
  • Familiarity with basic techniques and principles in molecular biology, biochemistry or immunology
  • Willingness to learn new technologies and methods and operate outside of comfort zone
Eligibility Requirements
  • Citizenship: LPR or U.S. Citizen
  • Degree: Master's Degree or Doctoral Degree received within the last 60 month(s).
  • Discipline(s):
    • Computer, Information, and Data Sciences (1 )
    • Life Health and Medical Sciences (6 )
    • Mathematics and Statistics (2 )