Manager, Cell Therapy Manufacturing in Summit, NJ
Core
Manage and provide oversight of a Work Centered Team (WCT) executing Cell Therapy manufacturing processes to ensure safety, compliance, and continuous improvement.
Role type
Manufacturing Manager (Cell Therapy)
Builds
Cell Therapy products (e.g., CAR T)
Domain
Biopharmaceuticals / Cell Therapy Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, cGMP SOP execution, batch record review, resource management, team building, training compliance, deviation management, CAPA participation, budget control, cross-functional collaboration
Preferred skills
Hands-on Cell Therapy manufacturing expertise, CAR T manufacturing knowledge, leadership in multi-product commercial facilities
Technologies
Workday, Electronic Batch Record systems
Responsibilities
Ensure WCT members execute manufacturing according to cGMPs and SOPs; perform batch record reviews; manage production scheduling and resource availability; hire personnel and conduct performance reviews; ensure 100% training compliance; manage deviations and CAPAs; control expenses within influence; lead weekly Tier and performance review meetings.
Seniority
Manager, hands-on IC with team leadership