*Applications will be reviewed on a rolling-basis.
A research opportunity is available at the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality/ Office of Testing and Research (OTR) 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.
Nitrosamines are probable carcinogens and their presence in drug products can be a serious safety risk. This project aims to assess the prevalence of nitrosamines in drug products, to understand the risk factors of nitrosamine formation, and to develop suitable analytical tool kits for risk assessment of nitrosamines in pharmaceutical products.
Under the guidance of the mentor, the participant will learn to use wet chemistry techniques (e.g., chromatography – gas chromatography (GC) and High Performance Liquid Chromatography (HPLC), spectroscopy, mass spectrometry) and other modern analytical techniques to characterize new and generic drug formulations. The participant will also engage in various laboratory activities such as sample generation and preparation, laboratory analysis and execution of experimental designs to fully develop methods and understand drug formulations and stability in various storage conditions. Participants will also participate in data evaluation, statistical analysis, 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 in your email.