Fellow, Scientist - Global Sterility Assurance

Fellow, Scientist - Global Sterility Assurance

Boston Scientific is seeking a distinguished and visionary Sterility Assurance Fellow Scientist to join our Global Sterility Assurance team. This role serves as a senior technical leader, responsible for shaping and advancing sterility assurance strategies across our global manufacturing network. The successful candidate will bring deep scientific expertise, strategic insight, and a passion for innovation in delivering novel sterilization methods and developing contamination control processes.

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:

• Ph.D. or 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.