Role Summary
Manager, Value Stream CAR-T Manufacturing. Responsible for managing and overseeing a Work Centered Team (WCT) executing CAR-T cell therapy manufacturing processes, ensuring safety, compliance, and continuous improvement within Manufacturing Operations. Reports to Senior Manager, Manufacturing.
Responsibilities
- Values: Lead by example and drive the team to adhere to the BMS values of Inclusion, Accountability, Innovation, Urgency and Passion.
- GMP: Ensure the WCT members manufacture Cell Therapy products according to cGMPs, SOPs, and WIs.
- Safety: Promote safe work practices, conduct safety Gemba walks, maintain equipment, and ensure production records are accurate and complete.
- Process Expertise: Maintain hands-on knowledge of Unit Operations, backfill as needed, and develop CAR-T manufacturing expertise.
- Resource Management: Provide Production Scheduling with information on resource availability and track attendance/absences; hire personnel as needed within budget.
- Priorities: Set WCT priorities, monitor performance, and report progress in site and functional meetings.
- Training: Ensure appropriate CAR-T GMP training, maintain 100% on-time training completion, and confirm proficiency before tasks.
- Team Building And Development: Build high-performing WCTs, recruit, manage performance reviews, mentor, and develop cross-functional relationships.
- Deviations: Proactively reduce deviations, manage No Impact deviation records, and close out deviations on time.
- CAPAs, Change Controls & Projects: Participate as required by business needs.
- Budgets: Control expenses within influence (OT, Supplies, T&E).
- Meetings: Facilitate weekly Tier and Performance Review meetings, participate in monthly Manufacturing Performance Review, and daily production scheduling meetings.
- Behaviors: Foster teamwork, mitigate risks, coach, problem-solve, and drive continuous improvement using Go & See and Improvement/Coaching Kata.
- Knowledge & Skills: Knowledge of EHS and cGMPs, biotechnology principles, lean manufacturing, and strong communication.
Qualifications
- Basic Requirements: Bachelor's degree in a related field or equivalent experience; 5+ years GMP manufacturing experience; minimum 2 years of leadership experience with direct reports.
- Preferred Requirements: Advanced degree preferred.
Education
- Bachelor's degree in related field preferred; equivalent work experience considered.
Skills
- Extensive knowledge of EHS and cGMPs; aptitude for biotechnology principles and manufacturing systems.
- Lean manufacturing knowledge; excellent communication skills.
Additional Requirements
- Working conditions include potential exposure to contained human blood components, cleanroom environment, PPE requirements, and ability to lift up to 25 pounds.