Chemist, Prin

Remote Eligible: Hybrid

Onsite Location(s): Arden Hills, MN, US, 55112

Additional Locations: 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.

We have an exciting opportunity for a R&D Analytical Chemistry Principal Chemist with excellent understanding of gas chromatography with quadrupole or accurate mass spectrometer and FID detection; or liquid chromatography with accurate mass spectrometer, UV, or charged aerosol detectors. As a technical leader in the laboratory, you will lead chemical characterization projects, supervise team members both directly and indirectly, and coordinate with our internal customers.
The medical device products supported include products across the Boston Scientific portfolio.

Your responsibilities include:

Science

• Lead a gas or liquid chromatography area dedicated to chemical characterization and unknowns analysis of extractables and leachables from medical device products
• Remain current with ISO 10993, ISO 17025, FDA, and other regulatory agency requirements for chemical characterization of medical device and combination products
• Provide meaningful guidance and review/approval regarding scientific analytical strategies and approaches
• Drive the development and sustainment of functional area tools and methodologies that align with business needs

Quality

• Establish and promote a work environment that supports the quality system and analytical lab cGMP and ISO 17025 infrastructure, execution, documentation, and compliance
• Ensure that the your areas of responsibility are always audit ready

Project and People Leadership

• Guide projects to completion from inception through regulatory review
• Lead team members to achieve analysis goals and meet regulatory expectations
• Establish meaningful BSC cross-functional team relationships and collaborations
• Ensure compliance with company policies and procedures
• Provide guidance and training to staff, assist subordinates in attaining career goals, motivate individuals to achieve results
• Determine schedules and resources (facility, equipment, supplies)
• Determine staff and your work assignments and schedules to meet lab and customer completion dates and deliverables mutually agreed upon.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives

What we’re looking for:
Minimum Qualifications

• BS in chemistry or relevant field with emphasis in analytical chemistry
• 8 years with a BS (or 5 years with an MS or 3 years with a PhD) of analytical chemistry experience with direct application and a good understanding of techniques including gas or liquid chromatography with mass spectrometry detection and sample preparation
• Analytical chemistry experience should include 3 years of chemical characterization analysis per ISO 10993
• Experience applying ISO 10993 and ISO 17025 requirements to laboratory work and leadership activities
  

Preferred Qualifications

• MS or PhD in analytical chemistry with an emphasis in chromatography and 5 years of analytical chemistry experience in chemical characterization per ISO 10993
• Experience with Thermo Vanquish/Orbitrap LC/MS, Thermo Orbitrap GC/MS, or Agilent GC/MS Systems
• Strong experience with Compound Discoverer and Chromeleon software
• Excellent understanding of polymers chemistry or materials science
• Medical device or pharmaceutical analytical chemistry laboratory experience, especially in chromatography characterization and investigative analyses
• Working experience in performing analyses and preparing documentation within FDA, ISO 17025, and other regulatory environments
• Supervisory experience directing 2-4 analytical chemists
• Excellent organizational, communication, and collaboration skills
• Excellent technical execution, writing, and documentation skills for chromatographic analysis
• Experience in directing chromatography analytical chemists

Requisition ID: 563249

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!