Manufacturing Manager, Liso-cel CAR-T, Manufacturing Operations at Bristol Myers Squibb in Summit West - NJ - US

Job description

• The Manager, CAR-T Manufacturing Operations is responsible for leading compliant, safe, and reliable execution of commercial CAR-T manufacturing activities in an aseptic cGMP environment. This role provides direct leadership to manufacturing personnel, ensures adherence to approved procedures and quality standards, supports operational readiness, and drives continuous improvement across people, process, safety, quality, and performance outcomes.

Responsibilities

• Ensure compliant execution of commercial CAR-T manufacturing operations in accordance with cGMP requirements, approved SOPs, work instructions, batch records, and quality standards.
• Maintain hands-on manufacturing expertise and provide technical guidance, training, coaching, and real-time operational support to ensure successful product execution and schedule adherence.
• Gain and maintain full process qualification, supporting manufacturing activities as needed to ensure operational flexibility, team capability, and production continuity.
• Drive a strong safety culture through leadership presence, shopfloor engagement, Gemba activities, risk identification, hazard mitigation, and adherence to workplace safety practices.
• Oversee batch record review, manufacturing documentation, and data integrity compliance, ensuring adherence to ALCOA+ principles and right-first-time performance.
• Manage workforce planning, staffing, scheduling, hiring, onboarding, performance management, training compliance, and employee development to ensure operational readiness.
• Monitor and communicate operational performance through KPIs, production metrics, tier meetings, performance reviews, and resource planning activities.
• Ensure completion of all site-required standards and expectations, including required training, safety activities, quality culture expectations, walkthroughs, operational readiness activities, and applicable compliance requirements.
• Partner cross-functionally with Quality, Supply Chain, Warehouse, Manufacturing Science & Technology, and other stakeholders to maintain compliant and efficient manufacturing processes.
• Lead deviation management, root cause analysis, CAPAs, change controls, and continuous improvement initiatives to reduce risk, improve performance, and prevent recurrence.
• Champion Lean manufacturing principles, visual management, problem-solving methodologies, and coaching practices to drive operational excellence and employee engagement.
• Manage departmental resources and expenses, ensuring effective utilization of personnel, equipment, materials, and budget.
• Identify, escalate, and mitigate operational risks that could impact product quality, compliance, patient safety, or production continuity.

Requirements

• Patient-focused decision making with a strong commitment to quality and compliance.
• Visible shopfloor leadership and ability to coach teams in real time.
• Strong ownership, accountability, and sense of urgency in resolving operational issues.
• Ability to balance people leadership, technical execution, documentation quality, and business priorities.
• Clear, professional communication with strong cross-functional partnership and escalation judgment.
• Demonstrated understanding of manufacturing documentation, batch record execution, deviation management, change control, CAPA processes, and data integrity expectations.
• Ability to lead in a fast-paced, patient-focused manufacturing environment while maintaining strong attention to quality, safety, compliance, and schedule adherence.
• Strong people management skills, including coaching, performance management, conflict resolution, accountability, team engagement, and employee development.
• Effective communication and collaboration skills with the ability to partner across functions, escalate risks appropriately, and influence without direct authority.
• Bachelor’s degree in life sciences, engineering, biotechnology, or a related discipline, or an equivalent combination of education and relevant manufacturing experience.
• Experience working in a regulated cGMP manufacturing environment, preferably within biologics, cell therapy, aseptic processing, or pharmaceutical manufacturing.
• Prior managerial leadership experience in CAR-T, cell therapy, biologics, or aseptic manufacturing operations.
• Experience supporting commercial manufacturing operations, operational readiness, training qualification, and inspection readiness activities.
• Knowledge of Lean manufacturing, visual management, tiered communication, Gemba, root cause analysis, and continuous improvement tools.
• Experience managing shift-based teams, schedules, staffing plans, training plans, and resource allocation in a manufacturing environment.

Skills

Required

• Leadership
• Coaching
• Communication
• Collaboration
• Problem-solving
• Accountability
• Conflict resolution
• Team engagement
• Employee development
• cGMP
• SOPs
• Batch records

Benefits

• Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
• U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
• Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
• U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
• Summit West - NJ - US: $103,560 - $125,495
• The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.