*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 Silver Spring, Maryland.
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 work covers more than just medicines.
The project goal is to develop a mechanistic understanding to determine risk of vaping opioids and the in vitro permeation comparison when opioid drugs are taken by different routes of administration. The permeation system that will be used in this study will be adapted from one that is used in cigarette smoke exposure systems such as the Vitrocell system. The project will also require a technical evaluation of the aerosol size distribution determination of vaping constituents using a Scanning Mobility Particle Sizer, or SMPS. Mass Spectrometric methods will need to be developed to analyze opioids including any impurities that may be produced during vaping.
Under the guidance of the mentor, the participant will gain an understanding about the current regulatory requirements and the assessment of innovator and generic opioid drug products and will also expand the participant’s knowledge about the in vitro permeability and bioavailability comparisons of complex drug 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.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.