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.           

About the Role

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.

Your Key Responsibilities will include:

• 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.

Required Qualification:

• 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,

• Preferred Qualifications:

• 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.
• Proven experience managing an operating budget of at least 3.5M
• Hands-on execution of analytical test methods (e.g., GCMS, LCMS, ICP-MS)
• Direct experience supporting global regulatory submissions.
• Experience overseeing external contract laboratories or vendor networks.
• Participation in industry standards development or regulatory working groups.
• Demonstrated ability to translate complex analytical data into clear regulatory and business decisions.
• Strong cross-functional collaboration skills and the ability to influence without authority

Requisition ID: 621213 

Minimum Salary: $ 133700 

Maximum Salary: $ 254000 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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 Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.  The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.