Boston Scientific is seeking a Sterility Assurance Fellow Scientist to provide senior technical leadership in shaping and advancing sterility assurance strategies across its global manufacturing network, focusing on innovation in sterilization methods and contamination control processes.
Requirements
- 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).
- 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).
Responsibilities
- 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.
Other
- Bachelor’s degree in Microbiology, Pharmaceutical Sciences, Biomedical Engineering, or a related field (or equivalent experience).
- Strong communication and influencing skills across all levels of the organization.
- Strategic mindset with the ability to translate complex technical concepts into actionable business outcomes.
- This role follows a hybrid work model requiring employees to be in our local office at least three days per week.
- Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
