*Applications will be reviewed on a rolling-basis.

A research opportunity is available with the Office of Pharmaceutical Quality / Office of Testing and Research, at the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.

The misuse and abuse of prescription opioids represents a major U.S. public health issue. In addition, recent post-marketing data of reformulated Opana has highlighted serious safety concerns associated with unintended use of ADF (abuse deterrent formulation) product. Among the many considered causes, the excipient used in the product (polyethylene oxide, PEO) was thought to be a major factor but there is no guideline on how to determine the safety of an excipient when used through a non-intended route of administration. The aims of this project are to better understand the relationship between excipients, manufacturing and manipulation methods and toxicological outcomes associated with non-intended use of ADF opioids and to develop in vitro tools to allow safety evaluation of ADFs.

The participant will be trained within a highly multi-disciplinary team of experts from chemistry, medical device, material science, pharmacology and toxicology, and develop deep understanding of the regulatory review and policy process. The participant will have the opportunity to be a part of the research team to develop innovative methodologies to overcome unique regulatory challenges.

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.

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.