Boston Scientific Fellow Scientist - Global Sterility Assurance 

United States, Minnesota 

967932052

Your responsibilities will include:

• Act as a global subject matter expert in sterility assurance, aseptic manufacturing, and microbiological control.
• Develop strategies with respect to design for sterilization, sterilization modality selection, sterilization cycle design and product validation approaches.
• Lead the development and implementation of contamination control and sterility assurance processes aligned with regulatory expectations and industry best practices.
• Provide technical leadership during regulatory inspections, internal audits, and risk assessments.
• Collaborate cross-functionally with R&D, Quality, Regulatory Affairs, and Operations to ensure robust sterility assurance programs.
• Mentor and guide New Product Introduction technical teams, fostering a culture of scientific excellence and continuous improvement.
• Represent the company in external forums, including industry working groups, regulatory engagements, and scientific conferences.

Required qualifications:

• Bachelor’s degree in Microbiology, Pharmaceutical Sciences, Biomedical Engineering, or a related field (or equivalent experience).
• Minimum of 15 years of experience in sterility assurance, aseptic processing, or sterile product manufacturing.
• Demonstrated leadership in developing and executing contamination control strategies.
• Competency in multiple industrial terminal sterilization methods (e.g., EO, gamma, electron beam, moist heat, dry heat).
• Deep understanding of global regulatory requirements (e.g., FDA, EMA, ICH, PIC/S, ISO).
• Strong communication and influencing skills across all levels of the organization.

Preferred qualifications:

• M.Sc. or Ph.D. in a relevant discipline
• Technical expert in ethylene oxide, radiation, steam, vaporized hydrogen peroxide; firm understanding and application of novel sterilization methods.
• Proven ability to lead global cross-functional initiatives.
• Recognized thought leader in the field (e.g., publications, presentations, industry involvement).
• Strategic mindset with the ability to translate complex technical concepts into actionable business outcomes.

What We Offer:

• Opportunity to shape global sterility assurance strategy and influence industry standards.
• Collaborative and innovative work environment.
• Competitive compensation and benefits package.
• Professional development and leadership growth opportunities.

Maximum Salary: $ 232000

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.

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.