Associate Director, Chemical Characterization Lab

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.

The Associate Director of the Chemical Characterization Lab (CCL) at Boston Scientific, will lead a talented team of analytical chemists performing critical testing in a highly specialized ISO 17025‑accredited analytical laboratory serving all business units across the company.

You will provide scientific, operational, and regulatory leadership for chemical characterization and extractables & leachables testing under ISO 10993-18; providing data that directly enable global product registrations and sustained market access across the portfolio. You will be responsible for ensuring that Boston Scientific remains at the forefront of analytical science, regulatory readiness, and laboratory excellence.

This is a hands‑on leadership position responsible for setting strategy while ensuring flawless execution across a growing, highly technical organization.

This role is onsite out of the Arden Hills, Minnesota office location.

• Lead, coach, and develop a high‑performing team of analytical chemists, study directors, and scientific subject matter experts.
• Foster a culture of scientific rigor, data integrity, safety, and continuous improvement.
• Build future capability through talent development, succession planning, and organizational growth.

• Establish the long‑term strategy for Boston Scientific’s enterprise chemical characterization capability.
• Define analytical standards, method validation frameworks, and study execution practices that support global regulatory submissions.
• Balance strategic priorities with operational execution to meet enterprise demand for testing capacity and turnaround time.

• Own the ISO 17025 quality management system and ensure continuous audit readiness.
• Lead responses to FDA, notified body, and external audit questions related to chemical characterization.
• Interpret evolving global regulatory expectations and translate them into compliant, defensible testing strategies.

• Provide authoritative interpretation of chemical characterization data and partner with toxicologists to ensure rigorous risk assessments in support of product safety evaluations.
• Guide teams through complex technical, operational, and regulatory challenges impacting product approvals.
• Develop innovative analytical approaches to support new materials, novel technologies, and emerging product platforms.

• Partner closely with R&D, Regulatory, Quality, Toxicology, Manufacturing, and external laboratories.
• Influence decision‑making across functions through expert scientific recommendations and regulatory insight.
• Represent Boston Scientific externally with regulators, standards organizations, suppliers, and industry collaborators.

• Degree in Analytical Chemistry, Chemical Engineering, Materials Science, or a related technical discipline.
• Minimum of 12 years of related work experience with a Bachelors degree or minimum of 10 years with a Masters degree or minimum of 8 years with a Ph.D.
• Significant experience in analytical chemistry or chemical characterization within the medical device industry or related regulated industry.
• Demonstrated leadership experience in an ISO 17025‑accredited laboratory or equivalent regulated environment.
• Deep technical expertise in chemical characterization methods relevant to ISO 10993-18 (e.g., GCMS, LCMS, ICP-MS, NVR).
• Strong understanding of FDA and global regulatory expectations for chemical characterization and biological evaluation,

• Advanced degree preferred
• Analytical service lab management within a medical device company.
• Proven experience leading and developing highly technical teams of at least 15 members.
• Pr…