*Applications will be reviewed on a rolling-basis.
APPLY THROUGH EXTERNAL LINK. RESUME MUST BE SUBMITTED WITH APPLICATION.
A research opportunity is available in the Office of Generic Drugs (OGD) / Office of Research and Standards (ORS), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
This project will support the conduct of research to investigate scientific issues that are encountered during review of regulatory submissions of generic drugs. In addition, research is important for the development of guidances and recommendations that can guide generic product development during the pre-ANDA phase.
Under the guidance of a mentor, the participant will use a variety of analytical techniques (i.e. HPLC, dissolution, electron microscope) to characterize and assess the quality of drug products and also receive training for developing and validating advanced analytical and characterization methods to improve in vitro evaluation of drug products. The participant will be trained within a highly multi-disciplinary team of experts from chemistry, material science and pharmaceutical science, and gain a deep understanding of the regulatory review and policy process.
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 be currently pursuing or have received a 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-2020-0543) in your email.