FDA Postdoctoral Fellowship - Identification Criteria Development for Extractables and Leachables Non-Targeted Analysis

About the role

The Oak Ridge Institute for Science and Education (ORISE) Research Participation Programs at the U.S. Food and Drug Administration (FDA) offer students and recent graduates opportunities to participate in project-specific research and development at the Center for Devices and Radiological Health (CDRH).

Responsibilities

• Analyze extractable and leachable chemicals from materials used in medical devices.
• Develop and validate methods for extraction and sample analysis using GC-MS and LC-MS.
• Develop criteria for compound identification and quantification of substances contained in polymeric and other materials.
• Gain experience in E&L data processing with a focus on compound identification framework.
• Understand regulatory science and medical device biocompatibility review processes.

Requirements

• Currently pursuing or have a doctoral degree in relevant fields (Chemistry and Materials Sciences).
• Experience in sample preparation techniques, liquid chromatography mass spectrometry, gas chromatography mass spectrometry, and computational software.
• Track record in handling mass spectrometers and mass spectrometric data, including low and high resolution/accurate mass instruments.
• Experience in data analysis software packages, database generation, and statistical evaluation.
• Understanding of extractables studies and non-targeted analysis.
• Excellent scientific writing and communication skills.

Qualifications

• Doctoral degree within the last 60 months or currently pursuing.
• Hands-on experience in sample preparation techniques, liquid chromatography mass spectrometry, and gas chromatography mass spectrometry.
• Proven track record in handling mass spectrometers and mass spectrometric data.
• Experience in computational software such as Python, R, MATLAB, Java, C++.
• Experience in quantifying small molecules and polymers.
• Understanding of extractables studies and non-targeted analysis.
• Demonstrated ability to work independently and in multi-disciplinary teams.

Skills

• Hands-on experience in sample preparation techniques (e.g., solid phase extraction, liquid-liquid extraction).
• Experience in liquid chromatography mass spectrometry (LC-MS) and gas chromatography mass spectrometry (GC-MS).
• Experience in computational software such as Python, R, MATLAB, Java, C++.
• Experience in data analysis software packages, database generation, and statistical evaluation.
• Experience in quantification of small molecules and polymers.
• Understanding of extractables studies and non-targeted analysis.

Benefits

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

Pay

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

Schedule

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

Contact

For questions about the nature of the research, please contact the mentor, Samanthi Wickramasekara (samanthi.wickramasekara@fda.hhs.gov).