FDA Development of Home Use Preparation Instruction for Antimicrobials

Organization
U.S. Food and Drug Administration (FDA)
Reference Code
FDA-CDER-2019-0005
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
  • One educational or professional recommendation. Your application will be considered incomplete, and will not be reviewed until one recommendation is submitted.

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

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

Application Deadline
12/31/2019 3:00:00 PM Eastern Time Zone
Description

A research opportunity is available in the Office of Pharmaceutical Quality/Office of Testing and Research, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.

This is a collaborative project between CDER's Office of Pharmaceutical Quality/Office of Testing and Research and the Centers for Disease Control and Prevention (CDC). This project will examine analytical method development and validation for three class of antimicrobials, perform drug-soft-food compatibility studies for drug stability, develop and standardize methods to handle dosage forms before mixing with soft foods, and collect and summarize data.

Under the guidance of a mentor the participant will learn about principles and practices regarding analytical method development and validation to analyze drug dissolved in complex vehicles such as food. The core learning objective will be applied to analyze the dissolved drug in bio-relevant media to establish In vitro In vivo correlation (IVIVC) and to develop bio-analytical method development.

*Although the application deadline is December 31, applications will be reviewed on a rolling-basis.

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 be currently pursuing or 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:

  • Knowledge of high pressure liquid chromatography (HPLC) and other spectroscopic techniques
  • Prior experience with method development and validation of a drug
Eligibility Requirements
  • Degree: Master's Degree or Doctoral Degree received within the last 60 months or currently pursuing.
  • Discipline(s):
    • Engineering (2 )
    • Life Health and Medical Sciences (4 )
    • Other Physical Sciences (6 )