FDA Research Opportunity in Blood Components Safety

Organization
U.S. Food and Drug Administration (FDA)
Reference Code
FDA-CBER-2021-0039
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.

Description

*Applications will be reviewed on a rolling-basis, and this opportunity will remain open until a qualified candidate is identified.

A research opportunity is currently available in the Office of Blood Research and Review (OBRR) at the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) in Silver Spring, Maryland.

The laboratory's research focus is on identifying and evaluating pathogen inactivation methods relevant to stored blood and blood components' safety. The selected participant will receive training in the following aspects of the research and through this training, the participant will learn how the nation's blood supply can be protected from pathogens. Training will include:

  1. Screening novel methods and reagents for pathogen inactivation in blood and blood components (platelets, red blood cells and plasma).
  2. Evaluating the effect of such treatments on the survival and function of platelets and red blood cells and plasma.
  3. Evaluation of the treated plasma for the activities of coagulation factors.
  4. Mitigating the adverse effects (if any) of the treatments
  5. Developing biomarkers of product quality following pathogen inactivation treatments.

Anticipated Appointment Start Date: October 2021; 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 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 bachelor's, master's or doctoral degree in one of the relevant fields, or be currently pursuing one of the degrees with completion by the appointment start date. Degree must have been received within the past five years.

Preferred skills:

  • Hands-on experience in handling human blood and blood components, blood-borne pathogens (bacterial plating, viral assays, parasite survival assays etc.)
  • Experience in small animal handling and experiments with small animals
Eligibility Requirements
  • Degree: Bachelor's Degree, Master's Degree, or Doctoral Degree received within the last 60 months or anticipated to be received by 9/30/2021 11:59:00 PM.
  • Discipline(s):
    • Computer, Information, and Data Sciences (1 )
    • Life Health and Medical Sciences (46 )
Affirmation

Have you lived in the United States for at least 36 out of the past 60 months? (36 months do not have to be consecutive.)

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