FDA Oligonucleotide-mass Spectrometry Fellowship
*Applications will be reviewed on a rolling-basis.
A research opportunity is currently 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 St. Louis, Missouri.
Synthetic oligonucleotide therapeutics (ONTs) pose unique scientific and regulatory challenges by occupying a space between small-molecule drugs and biologics. Currently no ICH or FDA regulatory guidelines have been specifically established for ONTs, partially attributable to their broad range and structural complexity. To address this difficulty, a panel of analytical techniques are conventionally used for characterization and quality control (QC) release of ONTs, but these approaches are typically unable to directly monitor product quality attributes (PQAs) at the molecular level to ensure the desired product quality.
Under the guidance of a mentor, the participant will learn the construction of impurity database from the knowledge of the formation of mechanism of complex oligonucleotide-related impurities, gain hands-on experience of high resolution mass spectrometry including a variety of instrumentation and multiple software and advanced applications in analysis of complex system.
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.
Qualifications
The qualified candidate should be currently pursuing or have received a master's or doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2020-0532) in your email.