*Applications will be reviewed on a rolling-basis.
A research opportunity is currently 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 Silver Spring, Maryland.
This project focuses on developing and validating clinically meaningful in vitro disintegration and dissolution methods, which will assist in identifying the critical material and manufacturing process parameters that may impact the in vitro and in vivo performance of dissolving microneedles. This study will support the development of vital regulatory science tools such as in vitro dissolution and disintegration methods that the agency can use to evaluate microneedle based drug products; providing experimental data that supports the issuance of guidance documents for industry on DMN based drug products.
Under the guidance of a mentor, the participant will learn characterization of various transdermal, topical and microneedle formulation. This project will increase the participant’s readiness to respond to inquiries that comes from stakeholder to support review process, lab request or lab consults about transdermal, topical and microneedle products.
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.