*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of Pharmaceutical Quality (OPQ), Office of Testing and Research (OTR), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) located in Silver Spring, Maryland.
This project seeks to understand extended manufacturing process risks and their impact on drug product quality and quality assessments. During this project, we will develop or improve quantitative analysis procedures for product quality assessment and prediction. The project will assess the impact of process variables on pharmaceutical quality of drug product and drug substances including protein APIs.
Under the guidance of a mentor, the selected participant will learn to perform experiments encompassing process, drug substance production, and variables in drug product quality, while incorporating advanced process monitoring technologies and methodology. They will focus on the physicochemical characterization and in vitro performance of complex dosage forms and will perform formulation and pre-formulation design of experiments.
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-2021-0696) in your email.