Senior Analytical Chemist - Extractables and Leachables

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About The Role

The Chemical Characterization Laboratory (CCL) at Boston Scientific has an exciting opportunity for a Senior Analytical Chemist - Extractables & Leachables who has an excellent understanding of chromatography/mass spectrometry-based technology, including accurate mass GC/MS and/or LC/MS, to support chemical characterization testing of medical devices. The Senior Analytical Chemist will support testing of medical devices per ISO/IEC 10993-18:2020 in an ISO 17025 accredited laboratory. This role will involve significant data processing work, including interpretation of mass spectra and structural elucidation. The medical device products supported will include products across the Boston Scientific portfolio.

This role follows a fully onsite work model, requiring employees to be in our local office five (5) days per week. Relocation assistance is not available for this position at this time. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Responsibilities

• Interpret mass spectral data to identify unknown extractable and leachable compounds
• Expand and maintain spectral libraries of chemicals/materials
• Prepare analysis summary reports/documentation to communicate results to lab customers and the technical community
• Perform instrumental analysis with limited oversight using accurate mass LC/MS and GC/MS
• Complete tasks supporting analytical lab documentation and quality records
• Qualify and maintain test instruments and create associated documentation
• Provide technical guidance and training to junior lab personnel
• Develop, validate, and qualify analytical methods
• Perform hands-on testing in the analytical chemistry laboratory, including sample preparation and standard preparation
• Apply scientific principles and company policies and procedures, analyze data or situations, and exercise judgment to recommend solutions to solve problems
• Remain current with ISO 10993, ISO 17025, FDA, and other regulatory agency requirements for chemical characterization of medical device and combination products
• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures

Requirements

• Bachelor’s degree in chemistry or related field
• Minimum of six (6) years of professional, industry experience in an analytical laboratory with direct application of high resolution GC/MS and/or LC/MS and sample preparation; or minimum of four (4) years of such experience with a Master’s degree; or minimum of two (2) years of such experience with a PhD
• Minimum of two (2) years of professional experience in chemical characterization analysis per ISO 10993-18
• Technical expertise in LC/MS and/or GC/MS analysis and troubleshooting
• Proficiency in mass spectral data interpretation (LC/MS and/or GC/MS)
• Experience with at least one of the following software applications: Chromeleon, Compound Discoverer, Tracefinder, MassHunter, or similar
• Method development and validation experience
• Strong organizational, communication, and collaboration skills
• Strong technical writing and scientific laboratory documentation skills

Preferred Qualifications

• Advanced degree in chemistry-focused field
• Experience with Thermo Vanquish/Orbitrap LC/MS, Thermo Orbitrap GC/MS, or Agilent GC/MS Systems
• Strong experience with ThermoFisher Compound Discoverer and Chromeleon software
• Solid understanding of polymer chemistry or materials science
• Analytical chemistry lab work experience in the medical device and/or pharmaceutical industries, particularly in chromatography, characterization, and investigative analyses
• Experience applying ISO 10993 and ISO 17025 requirements to laboratory work
• Working experience in performing analyses and preparing documentation for submission to notified bodies under ISO 17025 requirements

Pay

The anticipated compensation for this role ranges from $85,000 to $161,500. Compensation will be commensurate with demonstrable level of experience, pertinent education, and other relevant factors. At Boston Scientific, it is not typical for an individual to be hired near the bottom or top of the range. Compensation for non-exempt (hourly), non-sales roles may also include variable compensation (e.g., overtime, shift differential) and annual bonus target. Compensation for exempt, non-sales roles may also include variable compensation, such as annual bonus target and long-term incentives.

Benefits

Core and optional employee benefits offered by Boston Scientific can be reviewed at www.bscbenefitsconnect.com.