Associate Research Scientist

About the Role

This Research Scientist performs studies supporting chemical characterization of materials to ensure safety and biocompatibility of materials for medical devices. The role includes identification and quantitation of chemical compounds using advanced chemical instrumentation, as well as analytical method development and validation to support materials characterization of medical device components and solutions.

Responsibilities

• Conduct drug container and medical device material evaluations studying the extractable/leachable compounds that can partition from device materials into fluids that are infused/transfused.
• Perform analysis of trace organic compounds for medical device materials using chromatography/mass spectrometry.
• Conduct elemental analysis for medical device materials using ICP/MS.
• Independently generate study designs/protocols, write, and distribute final reports.
• Occasionally work with samples that include human blood and blood components using procedural controls and personal protective equipment.
• Assist the lab team in managing a laboratory testing capability that provides comprehensive chemical evaluation of materials for use in medical devices.
• Support laboratory daily operations, calibrations, and supplies.
• Provide technical input/content for analytical method development and review.
• Serve as a technical expert in the use and operation of ICP/MS and chromatography instrumentation with mass spectrometry detection.
• Review laboratory documentation and results produced by colleagues.
• Provide collegial support to fellow scientists.
• Contribute to the integrated management system for occupational and environmental safety (ISO 14001 and ISO 45001).

Requirements

• Working knowledge of laboratory analytical chemistry, including classical techniques and advanced instrument systems.
• Significant experience (5+ years) with modern analytical tools and techniques in medical device and pharmaceutical product development.
• Experience with elemental analysis instrumentation including ICP/MS, gas chromatography (GC), and liquid chromatography (LC) equipped with mass spectrometry detectors.
• Significant experience (5+ years) with laboratory instrumental techniques, method development, and method validation.
• Experience with instrument system validation is desirable.
• Solid experience with analytical mass spectrometry, including advanced data processing systems.
• Proven ability as a study director with accountability for scientific study design, execution, issue resolution, and completion through audit.
• Strong written and verbal communication skills.
• Experience with FDA-regulated laboratory environments in drug and medical device industries, including GMP/GLP/GDP operations.
• Ability to perform analytical laboratory testing while demonstrating critical thinking, including study design, interpretation of complex data sets, and proposing next steps for investigations.
• Adequate structural chemistry knowledge to facilitate interpretation of mass spectral data.

Qualifications

• Bachelor’s degree in chemistry is required; advanced degree preferred.
• PhD in chemistry or a related discipline is preferred; alternatively, a Master’s degree in Chemistry with relevant experience will be considered.
• Must be able to effectively speak, read, write, and understand English to perform essential functions in a heavily regulated work environment.

Pay

Salary range: $85,000 - $100,000. Position is eligible to participate in a bonus plan with a target of 6% of the base salary. Final pay determinations will depend on factors including experience level, education, knowledge, skills, and abilities.

Benefits

• 401(k) plan with company contributions.
• Paid vacation, holiday, and personal days.
• Employee assistance program.
• Health benefits including medical, prescription drug, dental, and vision coverage.