*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 St. Louis, Missouri.
Millions of Americans use compounded drugs created by a pharmacist or physician at about 7,500 compounding pharmacies. Compounded drugs present risks for patients. FDA works with state regulatory authorities on the oversight of compounding activities, monitoring compounded drugs produced by outsourcing facilities registered under section 503B of the FD&C Act. FDA also conducts surveillance, for-cause, and follow-up inspections of compounders in response to complaints, such as reports of serious adverse events. A compounded drug is essentially a non-FDA approved new drug. FDA often does not have available methods to verify the safety, effectiveness and quality of a compounded drug and FDA’s regulating actions will be hindered by the lack of quality data for compounded drugs. The proposed research aims to develop rapid-screening analytical methods with advanced technologies for substances used in compounded drugs.
The participant will gain understanding in development of rapid-screening and advanced testing protocols and methods, as well as the FDA’s regulatory process, compliance strategies and enforcement actions in compounding. The rapid-screening and advanced testing protocols and methods will be developed, validated and evaluated through this project, and practical feasible tests will be transferred to FDA laboratories to advance FDA’s surveillance methodologies.
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 St. Louis, Missouri, area. 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.
If you have questions, send an email to ORISE.FDA.CDER@orau.org.