*Applications will be reviewed on a rolling-basis.
A research opportunity is currently 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.
OTR is a laboratory-based office, actively engaging in project-specific FDA research activities related to pharmaceutical quality and manufacturing. The project will focus on advancing the adoption of emerging technology for pharmaceutical freeze-drying. Throughout the course of this research project, and under the guidance of a mentor, participants will learn how to assess the risk of failure of a freeze-drying process, and develop methods for assessing quality attributes of freeze-dried biologics.
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.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2021-0598) in your email.