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A complete application consists of:
All documents must be in English or include an official English translation.
If you have questions, send an email to ORISE.FDA.CDRH@orau.org. Please include the reference code for this opportunity in your email.
*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of Science and Engineering Laboratories (OSEL), Division of Biology, Chemistry, and Materials Science (DBCMS), within the Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration (FDA) located in Silver Spring, Maryland.
The fellow will be trained in reviewing, analyzing, and using scientific data or other information to advance and convey understanding of materials science and chemical characterization in medical device evaluation, including understanding ISO 10993 – part 18 as well as use and understanding all other medical device related standards. With understanding of materials science and chemistry principles the fellow will be trained on the practices associated with designing experiments to address research topics in chemical characterization materials and data science. This will refine extraction protocols, accurate quantification of extractable compounds, as well as chemical equivalence studies as it relates to materials and manufacturing of materials, and use of chemical characterization methods and data science methodology.
Anticipated Start Date: March 2024.
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 on-site for laboratory research at FDA in the Silver Spring, Maryland, area. 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 (OPM) 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:
The qualified candidate will have received a Ph.D. from an accredited institution in the subject areas such as Chemistry, Analytical Chemistry, or a related scientific field.
Highly competitive applicants will have education and/or experience in one or more of the following:
Applicants who have completed part or all their education outside the U.S. must have their foreign education evaluated by an accredited organization to ensure that the foreign education is comparable to education received in accredited educational institutions in the U.S. This evaluation must also be provided by midnight Eastern Time on the closing date of this vacancy announcement. For more information on Foreign Education verification, visit the U.S. Department of Education. Another listing of services that can perform this evaluation is available at the National Association of Credential Evaluation Services (NACES) website.
I have lived in the United States for at least 36 out of the past 60 months. (36 months do not have to be consecutive.)
and
I have read the FDA Ethics Requirements.
ORISE GO
The ORISE GO mobile app helps you stay engaged, connected and informed during your ORISE experience – from application, to offer, through your appointment and even as an ORISE alum!
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