The Office of Testing and Research (OTR), Office of Pharmaceutical Quality (OPQ), seeks summer participants to engage with research related to the characterization of human drugs in the following areas: dissolution, inhalation, spectroscopy and mass spectrometric techniques. 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 research covers more than just medicines.
Under the guidance of the mentor, the participant will learn how to perform research in a pharmaceutical environment. The project assigned to the participant will be appropriate for the summer months and the activities will be performed in a laboratory setting.
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 appointment period is full-time for up to 4 months. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.
Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.
FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency. This agreement covers such topics as the following:
– Non-employee nature of the ORISE appointment;
– Prohibition on ORISE Fellows performing inherently governmental functions;
Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
– The fact that research materials and laboratory notebooks are the property of the FDA;
– ORISE fellow’s obligation to protect and not to further disclose or use non-public information.
Individuals should either be currently enrolled in or should have just received a bachelor’s or graduate degree in a chemistry, biological or physical sciences program. Applicants should have completed at least general chemistry level coursework or equivalent. Completion of organic chemistry and analytical chemistry or physical chemistry and laboratory experience is preferred.