*Applications will be reviewed on a rolling-basis.
Two research opportunities are currently available in the Office of Pharmaceutical Quality/Office of Testing and Research at the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) located in Silver Spring, Maryland.
The main goal of this project is to further develop the process understanding on continuous crystallization 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. Crystallization determines the final physiochemical properties of drug substance (e.g. polymorphs and particle size) and is considered one of the high risk areas in continuous manufacturing.
Under the guidance of a mentor the participant may be involved in: learning about the application advanced analytical technology for drug analysis, including but not limited to spectroscopy, mass spectrometry, ion mobility and liquid chromatography; the physiochemical evaluation and in vitro performance of complex dosage forms; performing design of experiments encompassing process, excipient, drug substance variables in drug product quality, while incorporating advanced process monitoring technologies and methodology; 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 six to twelve months, 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-2020-0552) in your email.