FDA Fellowship - Improvement of Framework for Extractions of Medical Device Materials

Oak Ridge Institute for Science and Education; Silver Spring (MD); Presencial; USD 33.000 - 47.000; Jornada completa

Descripción de la vacante

Oak Ridge Institute for Science and Education, through its DOE contract, administers an ORISE fellowship at FDA’s Center for Devices and Radiological Health in Silver Spring, MD. The project focuses on extractables and leachables analysis of challenging materials.

Under mentorship by Jacob Hill, fellows work full-time on refining chromatography and mass spectrometry methods, contribute to scientific articles, and complete required FDA ethics and education agreements during the appointment.

Formación

• Doctoral degree within the last five years or anticipated by 12/31/2026.
• Experience with chromatographic and MS-based analysis preferred.

Responsabilidades

• Refine extraction and measurement of chemicals from materials of construction.
• Operate chromatography and mass spectrometry equipment.
• Contribute to writing scientific articles.

Conocimientos

Analytical methods

Mass spectrometry

Educación

Doctoral degree in Chemistry or related field

Herramientas

HPLC/LC-MS

GC-MS

Descripción del empleo

Organization

U.S. Food and Drug Administration (FDA)

Reference Code

FDA-CDRH-2026-0032

Application Deadline

12/11/2026 3:00:00 PM Eastern Time Zone

Description

• Applications will be reviewed on a rolling-basis.

FDA Office and Location

A research opportunity is available within the Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA), located at Silver Spring, Maryland.

The mission of CDRH is to protect and promote public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. CDRH provides consumers, patients, caregivers, and providers with understandable and accessible science-based information about products. CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

Research Project

An educational research opportunity is available in the Chemical Characterization program in the FDA Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories (OSEL).

Silicone and Difficult Materials Project: This project will offer the opportunity to refine and streamline approaches to the extraction and measurement of chemicals from materials of construction that often pose exceptional difficulties during the characterization process. The data-driven methods will be developed through analysis and modeling of existing data, designing experiments, filling any deficiencies in available data, operating chromatography and mass spectrometry equipment, and participating in writing scientific articles.

Learning Objectives

Under the guidance of a mentor, you will gain experience in extractables and leachables analysis in a real-world setting as well as an understanding of regulatory science and medical device chemical characterization review processes.

Mentor

The mentor for this opportunity is Jacob Hill ([e-mail]). If you have questions about the nature of the research, please contact the mentor.

Anticipated Appointment Start Date

June 30, 2027. Start date is flexible and will depend on a variety of factors.

Appointment Length

The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.

Level of Participation

The appointment is full time.

Participant Stipend

The participant will receive a monthly stipend commensurate with educational level and experience.

Citizenship Requirements

This opportunity is available to U.S. citizens and Lawful Permanent Residents (LPR) only.

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 participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. 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.

Education

• 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 doctoral degree in one of the relevant fields. Degree must have been received within the past five years, or anticipated to be received by December 31, 2026.

Preferred Skills

• Familiarity with analytical methods such as chromatography and mass spectrometry
• Experience with LC-MS and GC-MS method development, optimization, and troubleshooting

Point of Contact

Richard

Eligibility Requirements

• Citizenship: LPR or U.S. Citizen
• Degree: Doctoral Degree received within the last 60 months or anticipated to be received by 12/31/2026 11:59:00 PM.
• Discipline(s):
  • Chemistry and Materials Sciences
  • Analytical Chemistry
  • Chemistry (General)
  • Materials Sciences
  • Organic Chemistry
  • Physical Chemistry
  • Polymer Chemistry
• Computer, Information, and Data Sciences
• Engineering
• Life Health and Medical Sciences
• Affirmation: 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.)
• I have read the FDA Ethics Requirements.