FDA Cryo-scanning Electron Microscopy for Pharmaceutical Analysis Fellowship
*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of Pharmaceutical Quality/Office of Testing and Research, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in St. Louis, Missouri.
The Office of Testing and Research (OTR) is a laboratory-based office, actively engaging in project-specific FDA research activities related to pharmaceutical chemistry and pharmaceutical analysis. Research activities require extensive experimental work to generate the data and science necessary to advance pharmaceutical science. The pharmaceutical analyses performed will help inform FDA stakeholders for regulatory action.
Project activities include dissolution, chromatography, spectroscopy, mass spectrometry, as well as other modern analytical techniques to characterize new and generic formulations, including complex drugs and biologics. Under the guidance of a mentor, the participant will be involved in the following laboratory activities: sample generation and preparation, laboratory analysis and execution of experimental designs to fully develop methods and understand drug formulations and manufacturing processes. Participants will engage in data evaluation and documentation (publication, presentation or report) with their mentor to learn how to communicate regulatory science to FDA and industry stakeholders.
Qualifications
The qualified candidate should be currently pursuing or have received a doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date.
Preferred skills:
- Cryo-scanning electron microscopy (SEM) and associated sample preparation methods such as high-pressure freezing
- Background in nanotechnology and analytical/physical chemistry or material science
- Strong background in written and oral communication with a publication history in peer reviewed journals
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2020-0509) in your email.