Sr. Manager/ Associate Director Sterility Assurance, Cell Therapy

Bristol Myers Squibb • Madison, WI

2d • $143,180 - $190,849

About The Position

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.

Requirements

• 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 contamination control strategies.
• Strong knowledge of global regulatory requirements for aseptic processing and cell therapy manufacturing.
• 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.

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.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees