*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 Silver Spring, Maryland.
This project includes the use of modern analytical techniques to characterize new and generic products, including complex drug substance, formulation and biologics, use computer simulations and modeling for risk assessment, and apply a design of experiment approach to evaluate various manufacturing processes.
Participants will learn about sample generation and preparation, laboratory analysis, and execution of experimental designs to fully develop methods and understand drug formulations and manufacturing processes. In addition, 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 Silver Spring, Maryland, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.
The qualified candidate should be currently pursuing or have received a bachelor’s, master’s or doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2020-0565) in your email.
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