Manufacturing Manager, Liso-cel CAR-T, Manufacturing Operations

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.The purpose of the Manufacturing Manger role is to manage and provide oversight of a Work Centered Team (WCT) whose primary responsibility is the execution of Cell Therapy manufacturing processes. The Manufacturing Manager is responsible to ensure their WCT members maintain a culture of safety, compliance, innovation, and Continuous Improvement within the Manufacturing Operations function. This position reports Senior Manager, Manufacturing.Shift Available:Wednesday through Saturday, 5:00 p.m. to 5:30 a.m., with alternating Wednesdays off Key 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. Knowledge & Skills: Strong people-management skills supported by two years of experience. Extensive knowledge of EHS and cGMPs and the know–how to work and manage within a regulated environment. Demonstrates aptitude for biotechnology principles and manufacturing systems. Demonstrated proficiency in selection of team and effectively managing personnel issues. Adaptable to a fast paced, complex, and ever-changing business environment. Knowledge of lean manufacturing principles required. Excellent communication skills Minimum Requirements: 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. 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. Preferred QualificationsPrior 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. Key CompetenciesPatient-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. Working Conditions: Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary. Must be comfortable working with contained human blood components. Physical dexterity sufficient to use computers and documentation. Sufficient vision and hearing capability to work in job environment. Ability to lift 25 pounds. Must have the ability to work around laboratories and controlled, enclosed, restricted areas. Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet. Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas. Flexibility to don clean room garments and personal protective equipment (PPE). Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected. Routine exposure to human blood components. Exposure to strong magnets is likely. Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum. We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway. Compensation Overview: Summit West - NJ - US: $103,560 - $125,495 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 accou