Monograph Modernization Fellowship - CDER
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.
A research opportunity is available in the Office of Pharmaceutical Quality at the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) located at the New York District Office (ORA), Jamaica, NY.
CDER seeks to improve industry's understanding of what is expected from a product quality perspective for products and recipients that rely upon monographs. The objective of this project is to evaluate proposals for new and revised USP standards by testing approaches outlined in the proposals from USP. Work on analytical method development for high priority monographs will be identified by the mentor.
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 12 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 Jamaica, NY area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.
Applicants must have received a master's or doctoral degree in chemistry or pharmaceutical science within five years of the desired starting date, or completion of all requirements for the degree should be expected prior to the start date. Technical experience in HPLC and general spectroscopy is desired.
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