Overview

*Applications will be reviewed on a rolling-basis.

A research opportunity is currently available with the Food and Drug Administration (FDA) in Silver Spring, Maryland. This is a collaborative project between Center for Drug Evaluation and Research (CDER)/ Office of New Drugs (OND) and Center for Devices and Radiological Health (CDRH)/ Office of Science and Engineering Laboratories (OSEL). The participant will be placed in CDRH/OSEL.

The project will lead regulatory science efforts in experimental and computational methods for the assessment of emerging x-ray imaging technologies including spectral and scattering modes. This effort is centered on the characterization of small-angle x-ray scattering (SAXS) signatures from protein aggregates in the brain associated with neurodegenerative diseases including Alzheimer’s using tomographic imaging, photon-counting detectors, and polychromatic x-ray sources. The goal of the effort is to contribute to the regulatory science of emerging imaging technologies for quantifying biomarkers in neurodegenerative diseases and prepare the Agency for the evaluation of related products.

Under the guidance of the mentor, the participant will gain knowledge in developing and characterizing a prototype x-ray system using spectral and scattering methods for tomographic brain imaging. The participant will learn to evaluate emerging x-ray imaging technologies using photon-counting detectors as a biomarker quantification tool. The participant will have an opportunity to collaborate with a diverse group of scientists from physicist to biomedical engineer within and outside the FDA and actively present at conferences and publish in peer reviewed journals.

 

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 multiple laboratory areas. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.

Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA.  OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.

FDA Ethics Requirements If an ORISE Fellow, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at FDA.   For additional requirements, see FDA Ethics for Nonemployee Scientists.

FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency.  This agreement covers such topics as the following:

Non-employee nature of the ORISE appointment;
Prohibition on ORISE Fellows performing inherently governmental functions;
Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
The fact that research materials and laboratory notebooks are the property of the FDA;
ORISE fellow’s obligation to protect and not to further disclose or use non-public information.
Qualifications
The qualified candidate should have received a master’s or doctoral degree in one of the relevant fields. Degree must have been received within the past five years.

Preferred Skills/ Knowledge:

Knowledge in optical or x-ray instrumentation for imaging application.
Knowledge with LabVIEW programming for hardware control and data acquisition.
Knowledge with MATLAB or Python or others for data and image analysis.
Ability to solve technical challenges systematically with experimental and/or computational approaches.