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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 sample preparation and chromatography-based approaches for chemical characterization of medical devices? Do you enjoy hands-on laboratory testing including sample preparation and instrument analysis using FTIR, LC/MS or GC/MS?
We have an exciting opportunity for an Extractables & Leachables Chemist II who has a background in chromatography and mass spectrometry 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 FTIR analysis and maintain a spectral library
Perform instrumental analysis with oversight using a variety of techniques such as accurate mass LC/MS and GC/MS or ICP/MS
Support the establishment and maintenance of a spectral library of chemicals/materials
Support development, validation, and qualification of analytical methods
Prepare analysis summary reports/documentation to communicate results to lab customers and the technical community
Complete tasks on analytical lab documentation and quality records
Support qualification and maintenance of analytical instrumentation
Complete lab maintenance activities such as ordering, glassware washing, and other lab monitoring activities
Remain current with ISO 10993, ISO 17025, FDA, and other regulatory agency requirements for chemical characterization of medical device and combination products
Apply scientific principles and company policies and procedures, analyzes data or situations, and exercises judgment to recommend solutions to solve problems.
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 or MS in Analytical Chemistry, Chemistry, or relevant field with technical expertise in FTIR and chromatography analysis
BS with 4 years (or MS with 2 years) of industry experience in an analytical laboratory with direct application of techniques such as FTIR, gas/liquid chromatography with mass spectrometry detection, and sample preparation.
Experience in HPLC, GC, LC/MS or GC/MS instrument analysis and troubleshooting
Experience with FTIR analysis software and at least one of the following software applications: Omnic, Chromeleon, Compound Discoverer, MassHunter, or similar applications
Strong organizational, communication, and collaboration skills.
Strong technical writing and scientific laboratory documentation skills.
Preferred Qualifications Experience of chemical characterization analysis per ISO 10993
Experience with ThermoFisher iS50 Analytical FTIR spectrometer and RaptIR microscope
Experience with mass spectrometry using ThermoFisher Vanquish/Orbitrap LC/MS, ThermoFisher Orbitrap GC/MS, or Agilent GC/MS Systems
Basic understanding of mass spectral data interpretation (LC/MS or GC/MS)
Basic understanding of polymers chemistry or materials science
Experience applying ISO 10993 and ISO 17025 requirements to laboratory work
Working experience in performing analyses and preparing documentation within FDA, ISO 17025, and other regulatory environments
Medical device or pharmaceutical company analytical chemistry lab work experience, especially in chromatography characterization and investigative analyses.
Requisition ID: 572338
Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.
Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination.
