*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) located in St. Louis, Missouri. 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 FDA, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.
Addressing the opioid crisis is one of CDER’s top public health priorities. Surveillance of opioid-containing finished products allows the agency to assess the quality of drug products in the marketplace. The project will develop high-throughput characterization methods such as high performance liquid chromatography-high resolution mass spectrometry (HPLC-HRMS) for opioid drug products.
Under the guidance of the mentor, the participant will learn the development of sample preparation procedures utilizing an automatic sample preparation system. The participant will learn to carry out performance characterization of the preparation methods, potency determination of active ingredients and impurities characterization using high-throughput HPLC and mass spectrometry-based techniques. Participants will also learn about the 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.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2021-0704) in your email.