Boston Scientific Gruppe
Fellow, Scientist - Global Sterility Assurance
Boston Scientific Gruppe, Osseo, Minnesota, United States, 55369
Fellow, Scientist - Global Sterility Assurance
Onsite Location(s): Maple Grove, MN, US, 55311 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:
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. Note: 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. 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. Requisition ID:
612216 Salary Range:
Minimum $122,100 – Maximum $232,000 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. Boston Scientific is an equal opportunity employer. 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. Certain US-based positions may require acceptable proof of COVID-19 vaccination status. Candidates will be advised during the interview and selection process if vaccination is a condition of employment. Boston Scientific continues to evaluate its policies regarding the COVID-19 vaccine and will comply with applicable law and healthcare credentialing requirements. You will be expected to meet ongoing requirements for your role, including any new requirements, should company policies change regarding COVID-19 vaccination. Nearest Major Market:
Minneapolis Job Segment:
Compliance, Pharmaceutical, Regulatory Affairs, Law, Biomedical Engineering, Legal, Science, Engineering
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Onsite Location(s): Maple Grove, MN, US, 55311 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:
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. Note: 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. 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. Requisition ID:
612216 Salary Range:
Minimum $122,100 – Maximum $232,000 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. Boston Scientific is an equal opportunity employer. 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. Certain US-based positions may require acceptable proof of COVID-19 vaccination status. Candidates will be advised during the interview and selection process if vaccination is a condition of employment. Boston Scientific continues to evaluate its policies regarding the COVID-19 vaccine and will comply with applicable law and healthcare credentialing requirements. You will be expected to meet ongoing requirements for your role, including any new requirements, should company policies change regarding COVID-19 vaccination. Nearest Major Market:
Minneapolis Job Segment:
Compliance, Pharmaceutical, Regulatory Affairs, Law, Biomedical Engineering, Legal, Science, Engineering
#J-18808-Ljbffr