NIGHT SHIFT: Senior Manager, Cell Therapy Manufacturing in Devens, MA
Core
Senior Manager leading 24/7 cell therapy manufacturing unit operations (media prep, cell selection, processing, fill) for clinical and commercial CAR-T products in a cGMP facility.
Role type
Senior Manager, Cell Therapy Manufacturing
Builds
Licensed CAR-T products for clinical and commercial use
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
Manage commercial and clinical manufacturing teams and areas; Establish department goals, track KPIs, and drive continuous improvement; Author and approve manufacturing documents (SOPs, batch records, validation protocols); Implement and operate manufacturing systems compliant with cGMP; Ensure schedules for people, facility, equipment, and materials support expected capacity; Identify and mitigate manufacturing risks; Champion inspection readiness and Right First Time manufacturing; Establish team policies, organizational structure, and career ladders.
Seniority
Senior, hands-on IC