*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.

This project aims to evaluate the impact of variation in formulation and process parameters on the critical quality attributes (CQA) of modified release tablets using continuous manufacturing (CM). Using Consigma 1, the impact of critical material attributes and process parameters on the quality of the modified release granules of a model drug will be evaluated. A predictive mathematical model will be built with an overall objective to enhance process understanding to identify, establish and monitor or control critical material attributes and process parameters.

Under the guidance of the mentor, the participant will be trained on the operation of Consigma and the effect of process parameters on product performance. They will participate on implementation of PAT tools to monitor critical characteristics of the granules as a function of material attributes and process parameters and will be trained on derivatization and development of the mathematical relationships that control continuous processes.

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.