FDA Postdoctoral Fellowship - Identification Criteria Development for Extractables and Leachabl[...]

Oak Ridge Institute for Science and Education; Silver Spring (MD); On-site; USD 23,000 - 36,000; Full time

Benefits offered by this job

Monthly stipend

Job summary

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories (OSEL) in Silver Spring, Maryland, offers an ORISE Research Participation Program to analyze extractable and leachable chemicals in medical device materials, with method development and GC-MS/LC-MS analysis.

Under a mentor, you will gain hands-on experience in E&L data processing, compound identification frameworks, and regulatory science workflows.

Qualifications

• Pursuing or has doctoral degree in Chemistry, Materials Science, Analytical Chemistry, or related field (within last 5 years).
• Excellent scientific writing and communication skills.
• Experience with mass spectrometry data and regulatory science context is preferred.

Responsibilities

• Analyze extractable and leachable chemicals from medical device materials.
• Develop and validate extraction methods; perform GC-MS and LC-MS analyses.
• Identify and quantify substances; support regulatory science workflows.

Skills

Mass spectrometry

Python

R

MATLAB

Java

C++

Data analysis

Education

Doctoral degree

Tools

GC-MS

LC-MS

Mass spectrometers

Mass spectral databases

Job description

Organization

U.S. Food and Drug Administration (FDA)

Reference Code

FDA-CDRH-2026-0030

Application Deadline

6/30/2027 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), Office of Science and Engineering Laboratories (OSEL), located at Silver Spring, Maryland.

Program Overview

Oak Ridge Institute for Science and Education (ORISE) Research Participation Programs at the U.S. Food and Drug Administration are educational training programs designed to provide students and recent graduates, opportunities to participate in project-specific research and developmental at the Center for Devices and Radiological Health (CDRH). 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

This project will offer the opportunity to analyze extractable and leachable chemicals from materials used in medical devices. This will include method development and validation for extraction, sample analysis using GC-MS and LC-MS, development of criteria for compound identification and quantification of substances contained in polymeric and other materials to support CDRH’s regulatory mission.

Learning Objectives

Under the guidance of a mentor, you will gain experience E&L data processing with focus on compound identification framework. You will also gain understanding of regulatory science and medical device biocompatibility review processes.

Mentor

Samanthi Wickramasekara ([e-mail])

Anticipated Appointment Start Date

November 2026. 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, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.

Program Conditions

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

• 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 be currently pursuing or have a doctoral degree in the one of the relevant fields. Degree must have been received within the past five years, or be currently pursuing.

Preferred Skills

• Hands-on experience in following techniques including but not limited to: sample preparation techniques (e.g., solid phase extraction, liquid-liquid extraction), liquid chromatography mass spectrometry (LC-MS), and gas chromatography mass spectrometry (GC-MS).
• Proven track record of handling mass spectrometers/ mass spectrometric data including both low resolution and high resolution/ accurate mass instruments.
• Using different mass spectral database platforms for compound identification and data interpretation tools (vendor specific and open source)
• Experience with computational software such as Python, R, MATLAB, Java, C++ etc.
• Experience in quantification of small molecules and polymers
• Experience in data analysis software packages, database generation and statistical evaluation
• An understanding of extractables studies and non-targeted analysis.
• Demonstration of a track record of independent research.
• Demonstrated ability to participate in multi-disciplinary teams and groups to resolve difficult or controversial research questions.
• Excellent scientific writing and communication skills.

Point of Contact

Ashley

Eligibility Requirements

Degree: Doctoral Degree received within the last 60 months or currently pursuing.

Disciplines

• Chemistry and Materials Sciences
• Analytical Chemistry
• Bio-inorganic Chemistry
• Bio-organic Chemistry
• Biophysical Chemistry
• Chemistry (General)
• Environmental Chemistry
• Inorganic Chemistry
• Materials Sciences
• Organic Chemistry
• Physical Chemistry
• Polymer Chemistry
• Theoretical Chemistry

Affirmation

I am a U.S. Citizen, or 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.