Manager, Value Stream CAR - T Manufacturing

Overview

Manager, Value Stream CAR - T Manufacturing

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• 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 Work Centered Team (WCT) members execute the manufacturing of Cell Therapy products according to Current Good Manufacturing Practices (cGMPs) following the current, approved SOPs and Work Instructions (WIs)
• Manages shift and staffing to meet production schedules; coordinates with Production Scheduling to provide information on resource availability
• Maintains a culture of safety, compliance, innovation, and Continuous Improvement within Manufacturing Operations
• Facilitates weekly Tier meetings and other site-level reviews; participates in Daily Production Scheduling meetings and cross-functional manufacturing meetings

• Executes Cell Therapy manufacturing with hands-on expertise, demonstrates what good execution looks like to WCT members, and backs up resource requirements as needed
• Ensures all documentation produced by WCT members follows ALCOA+ principles; performs batch record reviews or reviews by exception
• Maintains knowledge of each Unit Operation, supports transfer of knowledge to new members
• Provides information to the Production Scheduling team on resource availability and tracks attendance/absences
• Supports CAPAs, Change Controls, deviations, and projects as required by the business
• Drives continuous improvement to prevent deviations and ensure timely closure

• Promotes a safe working environment; performs regular safety walks and ensures hazards are understood and mitigated
• Ensures documentation integrity and compliance with safety and GMP requirements

• Builds high-performing WCTs of Operators, Team Leads and Supervisors
• Recruits, interviews, and mentors; maintains Workday profiles for new hires
• Conducts performance reviews and provides feedback aligned with BMS values
• Helps employees with professional development and cross-functional collaboration
• Fosters a culture of learning and continuous improvement; develops cross-functional relationships with Quality, Warehouse, Supply Chain, and Manufacturing Science & Technology

• Ensures WCTs have appropriate CAR-T GMP manufacturing training in a multi-product facility
• Maintains 100% on-time training completion; ensures proficiency before task performance
• Monitors training due dates and allocates time for training activities
• Disqualifies personnel from GMP tasks if non-compliant with SOPs, WIs, or batch records

• Extensive knowledge of EHS and cGMPs in a regulated environment
• Biotechnology principles and manufacturing systems aptitude
• Experience in team selection and personnel management
• Lean manufacturing knowledge; adaptable to fast-paced environments
• Excellent communication skills

• Bachelor’s degree in related field or equivalent work experience
• 5+ years of GMP manufacturing experience
• Minimum of 2 years leadership including direct reports
• Green Belt in Operations Excellence preferred

• Advanced degree preferred

• Intermittent walking and sitting; ability to sit/stand for extended periods
• Comfort working with contained human blood components
• Ability to lift 25 pounds; capable of working around laboratories and restricted areas
• Cleanroom garments and PPE required in designated areas
• Compliance with cleanroom protocols and restrictions on outside materials

This job description describes the general nature and level of work performed by the person assigned to this position and does not state that they are the only duties and responsibilities.