Manager, Value Stream CAR-T Manufacturing

Role Summary

Manager, Value Stream CAR-T Manufacturing. Responsible for managing and overseeing a Work Centered Team (WCT) executing Cell Therapy manufacturing processes, ensuring safety, compliance, innovation, and continuous improvement within Manufacturing Operations. Reports to Senior Manager, Manufacturing. Shift available: Sunday - Wednesday onsite day shift, 5 a.m. – 5:30 p.m.

Responsibilities

• Leads by example and drives their team to adhere to the BMS values of Inclusion, Accountability, Innovation, Urgency and Passion
• Is accountable to ensure their WCT members execute the manufacturing of Cell Therapy products according to cGMPs, SOPs, and WIs
• Takes personal responsibility to work safely and to ensure their WCT members do the same
• Performs regular safety Gemba walks and demonstrates safe behavior
• Operates and maintains equipment to prevent injuries or incidents; accountable for Production Records
• Performs batch record reviews (BRR) or Electronic Batch Record review by exception
• Ensures documentation produced by their WCT members follows ALCOA+ principles and is right first time
• Resolves documentation errors to enforce manufacturing turnaround times
• Maintains hands-on expert knowledge of CAR-T manufacturing; back-fills as needed to meet production schedule
• Provides Production Scheduling information about resource availability and tracks absence
• Hires personnel who meet job criteria and BMS values within budget requirements
• Sets WCT priorities, monitors performance, and reports progress in site/functional meetings
• Ensures appropriate training levels for CAR-T GMP manufacturing and maintains 100% on-time training completion
• Ensures WCT members are proficient and qualified to perform manufacturing tasks
• Maintains training due dates and allocates time for training activities
• Disqualifies personnel from GMP tasks if non-compliant with SOPs or safety trainings
• Builds high-performing WCTs; recruits, interviews, and provides feedback to Talent Acquisition and HR
• Maintains Workday profiles for new hires; administers annual performance reviews
• Mentors and develops team; communicates company information for professional development
• Fosters a culture of learning through deviations, safety incidents, and coaching
• Develops cross-functional relationships with Quality, Warehouse, Supply Chain, and MST to sustain compliant processes
• Works to reduce deviations and drive continuous improvement; prepares No Impact deviation records as needed
• Participates in CAPAs, Change Controls and Projects as required
• Controls expenses within their influence (OT, Supplies, T&E)
• Facilitates and leads weekly Tier meetings and weekly Performance Review meetings for their WCT
• Participates in Monthly Manufacturing Performance Review and Daily Production Scheduling meetings
• Attends daily cross-functional manufacturing meetings to summarize activities or communicate issues
• Supports Go & See activities and Improvement/Coaching Kata; leads Leader Standard Work development
• Communicates expectations for Improvement/Coaching Kata and Go & See; recognizes team efforts
• Maintains a culture of accountability, problem solving, and cross-functional collaboration

Qualifications

• Basic Requirements: Bachelor's degree preferred or equivalent experience; 5+ years of manufacturing experience; minimum 2 years of leadership experience managing direct reports
• Knowledge of EHS and cGMPs; aptitude for biotechnology principles and manufacturing systems; lean manufacturing knowledge
• Excellent communication skills

Skills

• Strong leadership and people management
• Project management and prioritization
• Process improvement and lean principles
• Excellent communication and collaboration across functions
• GMP documentation and batch record management

Education

• Bachelor's degree in related field preferred; advanced degree preferred

Additional Requirements

• Working conditions include potential exposure to human blood components; cleanroom PPE; ability to lift 25 pounds; ability to work in controlled environments