Sr. Manager Sterility Assurance

 

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

 

Your Role: The Senior Manager, Sterility Assurance, provides leadership and oversight to the team that owns the elements of sterility assurance including Contamination Control Strategy, Aseptic Process Simulation, Aseptic Training and Core Monitor Program, Environmental Monitoring, Facility Disinfection, Gowning and Hygiene, and Sterility Assurance Risk Management programs.

 

Roles and Responsibilities:

• Assume SME leadership role for the site Contamination Control strategy, ensuring control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved.
• Ensure robust environmental monitoring programs are in place and adhered to in cleanroom environments. Conduct trend analysis of environmental monitoring data to drive continuous improvement.
• Responsible for the site’s microbiological/sterility assurance risk assessments. Collaborate with manufacturing, engineering, and validation teams to proactively identify and mitigate risks to product sterility.
• Provide technical support for significant sterility assurance investigations (examples: aseptic process simulations, drug product sterility testing, and other microbial excursions) to help identify root cause and implement appropriate corrective actions
• Support inspection readiness plans and interact with regulatory agencies during inspections on matters related to site Contamination Control and Sterility Assurance
• Owner of Aseptic Training Certification program and Aseptic Core Monitor Program
• Owner of Facility Disinfection, Gowning and Hygiene training and qualification programs
• Support new product transfers related to contamination control aspects of the manufacturing process including equipment design, materials of construction, performance qualifications, disinfectant efficacy, aseptic processes and techniques, and microbial method validations.
• Lead and manage a team of microbiology and sterility assurance professionals, providing guidance, training, and support as needed.
• Perform regular GEMBA style assessments of manufacturing operations including identification of deficiencies and opportunities for improvement.
• Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across functions and with multiple stakeholders.
• Champion a culture of quality and continuous improvement, instilling best practices and driving positive change in day-to-day operations.
• Keep abreast of industry trends, regulatory changes, and best practices related to cGMP and contamination control, incorporating updates into company practices and procedures.

 

Who You Are:

 

Minimum Qualifications:

• Bachelors degree in Engineering or a life science (Biology, Microbiology, etc.)

 

Preferred Qualifications:

• At least 10 years of experience in microbiology, sterility assurance, aseptic processing, or related fields in pharmaceutical or biotech manufacturing.
• Strong knowledge of regulatory requirements and industry standards related to sterile manufacturing and aseptic processing, including environmental monitoring.
• Ability to gown and gain entry to manufacturing areas.  Comfortable working in environments that require strict adherence to gowning and personal hygiene procedures.
• Thorough understanding of cGMP requirements for API, Pharmaceuticals, and Biologics manufacturing (e.g., 21 CFR 210 & 211, EU EudraLex, ICH Q7A).
• Strong leadership and interpersonal skills, with a proven ability to influence and motivate teams to achieve goals
• Excellent written and verbal communication skills, capable of effectively conveying complex information and providing guidance to teams.
• Advanced problem-solving abilities, capable of proposing and implementing effective solutions.
• Experience with regulatory inspections and audits is preferred.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science