Senior Chemist

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

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: 
Are you skilled at understanding and providing analytical analysis for chemical characterization of medical devices?  Do you enjoy hands-on laboratory testing including sample preparation, chromatographic analysis, and mass spectral data interpretation and reporting? 

 

We have an exciting opportunity for an Extractables & Leachables Senior Chemist who has an excellent understanding of chromatography/mass spectrometry-based technology, including accurate mass GC/MS and LC/MS, to support chemical characterization testing of medical devices. The medical device products supported include products across the Boston Scientific portfolio.

 

Your responsibilities include: 

• Perform hands-on testing in the analytical chemistry laboratory, including sample preparation (extractions, solvent exchange, concentration), gravimetric determination of non-volatile residue, and standard preparation

• Perform instrumental analysis with limited oversight using accurate mass LC/MS and GC/MS

• Mass spectral data interpretation for the identification of unknown extractable and leachable compounds

• Establish and maintain a spectral library of chemicals/materials

• Develop, validate, and qualify analytical methods

• Prepare analysis summary reports/documentation to communicate results to lab customers and the technical community

• Complete tasks supporting analytical lab documentation and quality records

• Qualify and maintain test instruments and create associated documentation

• Provide technical guidance and training of junior lab personnel

• May supervise others

• 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 to the Quality Policy and all other documented quality processes and procedures

 

What we’re looking for:

Minimum Qualifications

• BS, MS, or PhD in Analytical Chemistry, Chemistry, or relevant field with technical expertise in chromatography/mass spectrometry analysis

• BS with 6 years (or MS with 4 years or PhD with 2 years) of industry experience in an analytical laboratory with direct application of techniques such as gas or liquid chromatography with mass spectrometry detection and sample preparation. 

• Industry experience should include at least 2 years of chemical characterization analysis per ISO 10993

• Expertise in LC/MS and/or GC/MS instrument analysis and troubleshooting

• Strong mass spectral data interpretation skills (LC/MS and/or GC/MS)

• Experience with at least one of the following software applications: Chromeleon, Compound Discoverer, MassHunter, or Empower

• Method development and validation experience

• Strong organizational, communication, and collaboration skills.

• Strong technical writing and scientific laboratory documentation skills.

Preferred Qualifications

• Experience with Thermo Vanquish/Orbitrap LC/MS, Thermo Orbitrap GC/MS, or Agilent GC/MS Systems

• Strong experience with Compound Discoverer and Chromeleon software

• Solid understanding of polymers chemistry or materials science

• Medical device or Pharma company analytical chemistry lab work experience, especially in chromatography characterization and investigative analyses.

• Experience applying ISO 10993 and ISO 17025 requirements to laboratory work and leadership activities

• Working experience in performing analyses and preparing documentation within FDA, ISO 17025, and other regulatory environments

• Supervisory experience directing junior technical staff

 

 

Requisition ID: 572336

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