*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, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
As an emerging technology, the incorporation of various APIs with different release specifications within personalized 3D printed oral products has not been thoroughly evaluated for consistency of product performance. Therefore, the goal of the current project is to leverage expertise and experience and garner collaboration within the Office of Pharmaceutical Quality to identify the critical quality attributes (CQAs) of 3D printed polypills for cardiovascular treatment.
Under the guidance of a mentor, the participant will acquire deep understanding in the application of 3D printing technology. In addition, the participant will be exposed to the product development process involving risk assessment, identifying design spaces and developing novel characterization tools.
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.
The qualified candidate should 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-2020-0557) in your email.
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