NIGHT SHIFT: Senior Manager, Cell Therapy Manufacturing in Devens, MA
Core
Senior Manager responsible for overseeing 24/7 cell therapy manufacturing unit operations, managing teams, and ensuring compliance with cGMPs for clinical and commercial CAR-T products.
Role type
Senior Manager, Cell Therapy Manufacturing
Builds
Clinical and commercial CAR-T cell therapy products
Domain
Biopharmaceuticals / Cell Therapy Manufacturing
Required skills
Lean Manufacturing, cGMP compliance, team leadership, shift management, risk mitigation, SOP authoring, cross-functional collaboration
Preferred skills
None stated
Technologies
None stated
Responsibilities
Hire, mentor, and develop manufacturing staff; conduct performance reviews; ensure staff training on CAR-T GMP manufacturing; build cross-functional relationships with Quality, Supply Chain, MS&T, EHS, and F&E; plan and execute commercial and clinical operations; establish department goals and track KPIs; author and approve manufacturing documents; implement manufacturing systems; manage schedules for people, facility, equipment, and materials; identify and mitigate manufacturing risks; champion inspection readiness; establish team policies and organizational structure.
Seniority
Senior, hands-on IC