*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.
The Center for Drug Evaluation and Research (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 U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.
The project will address the opportunities and challenges associated with advanced manufacturing of drug substances; specifically, synthesis, workup, isolation, purification, and other critical steps within continuous processes. The research will focus on understanding of the advanced manufacturing process by investigating the process dynamics, critical process parameters (CPP) and the impact of expected/unexpected disturbances on critical quality attributes (CQA) of a drug substance.
Under the guidance of a mentor, the participant will learn about advanced manufacturing (e.g., continuous manufacturing) and analytical technologies for drug analysis, including but not limited to spectroscopy and liquid chromatography. The participant will learn about experimental design, incorporation of advanced process monitoring technologies and methodology using PAT tools, and training on and learning new manufacturing platforms for pharmaceutical products and new analytical techniques used for product quality characterization and manufacturing.
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 in your email.