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FDA Nanomedicine Characterization Fellowship

*Applications will be reviewed on a rolling-basis.

A research opportunity is available in the Office of Pharmaceutical Quality/ Office of Testing and Research (OTR), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in St. Louis, Missouri.

The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.

Nanomedicines require reliable and thorough characterization to deliver safe and effective treatments. A variety of analytical techniques must be used to characterize and determine the critical attributes of a drug product. The aim of this proposal is to combine physico-chemical characterization techniques with separation techniques to analyze and characterize each critical small component in a complex drug. Specifically, to integrate surface enhanced Raman spectroscopy (SERS), a non-destructive spectroscopic molecular identification technique, with chromatographic separation techniques such as size exclusion chromatography (SEC) or asymmetrical flow field flow fractionation (AF4) to provide more specific and in-depth chemical characterization of nanoscale components.  

The participant will learn to perform literature research and to familiarize themselves with analytical methods such as size exclusion chromatography (SEC), asymmetrical flow field flow fractionation (AF4), surface enhanced Raman spectroscopy (SERS) in pharmaceutical analysis.

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.

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