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

Role Summary

The Manufacturing Manager is 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 the Senior Manager, Manufacturing. Shift: Wednesday–Saturday, onsite night shift, 5 p.m.–5:30 a.m.

Responsibilities

• Lead and develop a high-performing WCT, including Operators, Team Leads, and Supervisors.
• Ensure manufacturing of Cell Therapy products complies with cGMPs, SOPs, and WIs; manage Production Records and BRR/Electronic Batch Records.
• Promote a culture of safety, quality, and continuous improvement; perform safety walks and address hazards.
• Manage unit operations hands-on when needed to meet production schedules and backfill as required.
• Provide production scheduling input and track resource availability and attendance; hire personnel per job criteria and budget.
• Set WCT priorities, monitor performance metrics, and communicate progress in site-level meetings.
• Ensure appropriate training for CAR-T GMP manufacturing and maintain 100% on-time training completion; ensure competency before tasks.
• Lead talent development, performance reviews, coaching, and cross-functional collaboration with Quality, Warehouse, Supply Chain, and Manufacturing Science & Technology.
• Drive deviations, CAPAs, change controls, and continuous improvement activities; lead Go & See and Improvement/Coaching Kata practices.
• Maintain Leader Standard Work and safety culture; resolve issues with tiered management escalation.

Qualifications

• Basic Requirements:
  • Bachelor's degree in a related field preferred or equivalent experience; strategic leadership ability.
  • 5+ years manufacturing experience in a GMP facility.
  • Minimum 2 years of leadership/people-management experience.
• Preferred Requirements:
  • Advanced degree preferred.

Skills

• Strong knowledge of cGMP, SOPs, WIs, batch records, and ALCOA+ documentation principles.
• Leadership, team building, coaching, and performance management.
• Project management, scheduling, and resource planning in a multi-product CAR-T environment.
• Problem-solving, root cause analysis, and continuous improvement mindset.
• Communication across cross-functional teams and senior management.

Education

• Bachelor's degree in a related field preferred; advanced degree optional.

Additional Requirements

• Working conditions include cleanroom environment, PPE, potential exposure to human blood components, and lifting up to 25 pounds.
• On-site requirement with specific shift; flexibility for schedule as needed.