FDA Research Opportunity in Nuclear Magnetic Resonance
A research opportunity is currently available with the U.S. Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Northeast Regional Laboratory (NRL) located in Jamaica, New York.
The fellowship is within the Northeast Regional Laboratory Facility where the following analytical techniques will be used to support critical regulatory testing and research activities: High Performance Liquid Chromatography (HPLC, UPLC), Size Exclusion Chromatography (SEC), Liquid Chromatography Mass Spectrometry (LC/MS/MS), Ion Exchange Chromatography, Spectroscopy (FTIR, UV/VIS, fluorescence, XRF, Raman), high resolution mass spectrometry (HRMS), Polarized Light Microscopy capabilities and Nuclear Magnetic Resonance Spectrometer (NMR).
The Pharmaceutical Analytical Group has been developed in Northeast Regional Laboratory to support the regulatory needs of Office of Regulatory Science (ORS) and Center for Drug Evaluation (CDER) scientists in the area of evaluation of protein-based pharmaceuticals (nano-scale) for therapeutic safety and efficacy to safeguard patient health and wellness. This group is formed to support ORA in developing and executing NMR-based analytical methods to qualify complex drugs.
Under the guidance of a mentor, the participant will be performing NMR analyses of pharmaceutical products. In this process, they will be learning about regulatory testing, generating regulatory analytical packages that can withstand scrutiny, learning about analytical quality controls and gaining experience with regulatory laboratory processes such as maintaining sample chain of custody, preparing samples per program guidelines in a way to preserve the regulatory value of the sample. They will also learn about horizon scanning and being able to identify projects to support regulatory needs in pharmaceutical analysis area.
The FDA Northeast Regional Laboratory is located in the York College Campus of City University of New York in Jamaica, New York. This can be conveniently reached by New York City Subway and Long Island Rail Road (LIRR).
Qualifications
The qualified candidate should have received a doctoral degree in one of the relevant fields, or be currently pursuing the degree and will reach completion by the start date of the appointment. Degree must have been received within five years of the appointment start date.
Close familiarity with NMR, NMR maintenance, preparing and running samples on the NMR, operating the instrument, and the ability to analyze and derive information from NMR spectra is preferred.
This opportunity is available to U.S. Citizens and Lawful Permanent Residents (LPR) only.
If you have questions, send an email to ORISE.FDA.OC.other@orau.org. Please include the reference code for this opportunity (FDA-ORA-2019-0003) in your email.