FDA Drug Product Ingredients Fellowship
*Applications will be reviewed on a rolling-basis.
A research opportunity is available at the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Policy for Pharmaceutical Quality (OPPQ) located in Silver Spring, Maryland.
This opportunity is in the Office of Policy for Pharmaceutical Quality (OPPQ), part of the Office of Pharmaceutical Quality (OPQ) within FDA’s Center for Drug Evaluation and Research (CDER). OPPQ leads a wide variety of projects covering issues of product quality that bring together numerous disciplines from across CDER, including those related to chemistry, toxicology, regulatory standards, pharmacology, pharmacy, and regulatory policy.
Under the guidance of a mentor, the participant will be trained in product data analysis and data management. The participant will increase their understanding of regulations and policies that impact drug development while gaining experience with tools that facilitate FDA research, with primary focus on: drug formulation, excipient quality and safety, database development, FDA research tools, materials to support communications, data management and reporting.
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.
Qualifications
The qualified candidate should have received a bachelor's, master's or doctoral degree, or are currently pursuing a master's or doctoral degree in one of the relevant fields, preferably in a pharmacy related field. 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-2020-0518) in your email.