*Applications will be reviewed on a rolling-basis.
A research opportunity is currently available at the U.S. Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Forensic Chemistry Center (FCC) located in Cincinnati, Ohio.
The primary aim of this project is to develop a method using an elemental analyzer interfaced with an isotope ratio mass spectrometer (EA-IRMS) to discriminate between monacolin K and lovastatin in red rice yeast (RYR) supplements. Monacolin K (naturally occurring in RYR) and its homologous biosynthetic statin, lovastatin (an active pharmaceutical ingredient (API)) can only be distinguished by examining their respective 13C/12C ratios. The initial phase of this project has yielded a working method. This final procedure will then be validated following FDA guidance, including collaboration with a second laboratory. The fully validated method will then be applied to various RYR supplements as part of a market basket survey to assess the occurrence of lovastatin as supplements are not permitted to contain an API. During the initial phases of this project, it is anticipated that the participant will obtain experience using LC with both ultraviolet detection (LC-UV) and mass spectrometric detection (LC-MS), EA-IRMS equipment, and various sample preparation tools.
The remainder of the appointment will focus on developing a direct analysis method for monacolin K/lovastatin using liquid chromatography (LC) and/or gas chromatography (GC) coupled with IRMS. This type of method could lead to decreased sample preparation and analysis time, thus increasing the method’s efficiency. It is anticipated that the participant will obtain experience in LC-MS, GC-MS, LC-IRMS, and GC-IRMS during the course of this project.
Ideally the results obtained from this project will be presented at scientific meetings and/or published in a peer-reviewed journal.
Anticipated Appointment Start Date: May 10, 2021 (start date is flexible)
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 eleven to twelve months, 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 Cincinnati, Ohio, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.