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.

*Applications will be reviewed on a rolling-basis.

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 St. Louis, Missouri.

The Office of Testing and Research (OTR) is a laboratory-based office, actively engaging in project-specific FDA research activities related to pharmaceutical chemistry and pharmaceutical analysis. Research activities require extensive experimental work to generate the data and science necessary to advance pharmaceutical science. The pharmaceutical analyses performed will help inform FDA stakeholders for regulatory action.

Project activities include dissolution, chromatography, spectroscopy, mass spectrometry, as well as other modern analytical techniques to characterize new and generic formulations, including complex drugs and biologics. Under the guidance of a mentor, the participant will be involved in the following laboratory activities: sample generation and preparation, laboratory analysis and execution of experimental designs to fully develop methods and understand drug formulations and manufacturing processes. Participants will engage in data evaluation and documentation (publication, presentation or report) with their mentor to learn how to communicate regulatory science to FDA and industry stakeholders.

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 St. Louis, Missouri, 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.

The qualified candidate should be currently pursuing or have received a doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date. 

 Preferred skills:

• Cryo-scanning electron microscopy (SEM) and associated sample preparation methods such as high-pressure freezing
• Background in nanotechnology and analytical/physical chemistry or material science
• Strong background in written and oral communication with a publication history in peer reviewed journals

• Degree: Doctoral Degree received within the last 60 months or currently pursuing.
• Discipline(s):
  • Chemistry and Materials Sciences (4 )
  • Engineering (1 )
  • Life Health and Medical Sciences (1 )
  • Physics (1 )
  • Science & Engineering-related (1 )