*Applications will be reviewed on a rolling-basis.
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. A research opportunity is available in the Office of Pharmaceutical Quality/ Office of Testing and Research (OTR), located in St. Louis, Missouri.
The research aims to develop validated methods to characterize peptide/protein drug products, including quality control and impurity testing. Under the guidance of a mentor, the participant will conduct research on peptide/protein pharmaceuticals using high-resolution accurate mass (HRAM) mass spectrometry (MS)-based methods. The participant will conduct analysis and experimentation in the laboratory utilizing prescribed procedures (protocols, standard operating procedures, etc.), and will document and report data. The participant will also perform much of their research on ZipChip, UPLC, Orbitrap MS and Q-IM-TOF MS in the FDA Saint Louis Facility.
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.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.