Sr. Manager/ Associate Director Sterility Assurance, Cell Therapy
Bristol-Myers Squibb, Madison, New Jersey, us, 07940
Senior Manager, Sterility Assurance
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. 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 therapiesproducts 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 contamination control strategies. Strong knowledge of global regulatory requirements for aseptic processing and cell therapy manufacturing. Travel:
This position requires 15-25% of travel (domestic and international) If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Devens - MA - US: $153,200 - $185,647 Madison - Giralda - NJ - US: $143,180 - $173,504 Seattle - WA: $157,500 - $190,849 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: 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. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your
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. 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 therapiesproducts 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 contamination control strategies. Strong knowledge of global regulatory requirements for aseptic processing and cell therapy manufacturing. Travel:
This position requires 15-25% of travel (domestic and international) If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Devens - MA - US: $153,200 - $185,647 Madison - Giralda - NJ - US: $143,180 - $173,504 Seattle - WA: $157,500 - $190,849 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: 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. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your