Concerns with Opiod Abuse Deterrent Properties - FDA CDER

Organization
U.S. Food and Drug Administration (FDA)
Reference Code
FDA-CDER-2018-0326
How to Apply

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

  • Two educational or professional references

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

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

Description

An opportunity is available at the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) in Silver Spring, Maryland.

A project in the Office of Pharmaceutical Quality (OPQ) Office of New Drug Products (ONDP) proposes to determine the degradation of both Low Molecular Weight (LMW) and High Molecular Weight (HMW) Polyethylene Oxide (PEO) to identify  degradants that may cause toxic effects in vivo.  The project will study the toxicological effects of injecting intact and degraded HMW and LMW PEOs in rats or guinea pigs.

Under the guidance of a mentor the participant may be involved in: study of both HMW and LMW PEOs; conducting in vitro laboratory manipulations to degrade PEOs; characterizing each degradant by size exclusion chromatography; administer both intact and degraded PEO samples into animals (rats or guinea pigs); and performing toxicological assessments by clinical chemistry, hematology, and gross pathology.

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.

The Homeland Security Presidential Directive-12 (HSPD-12) mandates a background check be completed for both U.S. Citizens and foreign nationals.  Foreign nationals must have resided in the U.S. for at least three (3) of the past five (5) years in order for FDA to be able to complete a background check.

Qualifications

The qualified candidate should be recently graduated from a pharmacology, toxicology or related field post graduate program and possess either a Master’s or PhD level degree.  Degree must have been received within the last 5 years of the appointment start date.   

Point of Contact
Eligibility Requirements
  • Degree: Master's Degree or Doctoral Degree received within the last 60 month(s).
  • Discipline(s):
    • Life Health and Medical Sciences (4 )
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