Sr. Manager/ Associate Director Sterility Assurance, Cell Therapy

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Position Summary

The Senior Manager, Sterility Assurance plays a critical role in safeguarding the integrity of Cell Therapy manufacturing by ensuring robust contamination control strategies and aseptic practices across the global network. This position drives compliance with international regulations and internal standards to enable the safe delivery of CAR-T therapies—products that cannot undergo terminal sterilization.

Serving as a key liaison among manufacturing sites, Quality, Cell Therapy leadership, CMO partners, and broader BMS teams, this role provides strategic oversight and technical expertise.

Duties/Responsibilities

• Designing aseptic training and qualification programs grounded in sound microbiological principles.
• Developing and publishing global sterility assurance standards.
• Managing change records and leading sterility assurance risk assessments.
• Ensuring operator aseptic technique across the network is consistently robust to mitigate contamination risks associated with manual processing steps.
• Rapid Response & Triage: Lead immediate containment and triage efforts for sterility breaches, including leaks, mold recoveries, and contamination events across a broad network of stakeholders.

Reporting Relationship

• This position reports to the Director, Global Sterility Assurance in CTTO

Qualifications

• Aseptic Training & Qualification
  • Design and deploy microbiology-based training programs for the Cell Therapy network, ensuring alignment with current regulatory expectations and best practices.
  • Develop and continuously improve the network aseptic qualification program (APQ) for CAR-T manufacturing operators, including periodic reviews.

• Compliance & Regulatory Expertise
  • Ensure adherence to GMP, global health authority requirements, and internal quality standards.
  • Provide technical guidance and act as SME during audits, inspections, and regulatory submissions.

• Risk Management & Data Analysis
  • Conduct sterility assurance risk assessments for aseptic processes and implement mitigation strategies.
  • Analyze trends and report internal/external 483 observations to governance forums to drive CAPAs.
  • Strong background in statistics and trend analysis for contamination control performance monitoring.

• Innovation & Digital Enablement
  • Champion innovative solutions and digital tools to enhance contamination control, aseptic oversight, and operator qualification.

• Collaboration & Leadership
  • Partner with Manufacturing, Quality, and Technical Operations to harmonize aseptic practices across global sites.
  • Excellent communication and influencing skills across a diverse, global stakeholder network.

• Technical Depth
  • Sound scientific understanding of the relationship between operator technique and contamination control.
  • Skilled in root cause analysis and investigational tools for microbiological issues in pharmaceutical manufacturing.
  • Proven experience defending sterility assurance programs during regulatory inspections.

Education/Experience/ Licenses/Certifications:

• MSc or BSc in Microbiology, Biology, or equivalent with 8+ years of relevant experience in aseptic processing environments.
• Demonstrated success with aseptic technique training in the biotech industry
• Proven leadership in designing training programs and implementing