Manager, Cell Therapy Manufacturing in Devens, MA
Core
Managing commercial operations for a 24/7 cell therapy manufacturing unit, overseeing unit operations like media preparation, cell selection, processing, and fill in compliance with cGMPs.
Role type
Manager, Cell Therapy Manufacturing
Builds
Clinical and commercial cell therapy products
Domain
Biopharmaceuticals / Cell Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP bioprocessing, cell therapy manufacturing techniques, aseptic processing, ISO 5 biosafety cabinet operations, BSL-2 containment, team leadership, deviation management, SOP development, equipment commissioning and validation
Preferred skills
Cell washing, cell separation, cryopreservation, cell expansion, automated equipment operation, bioreactor/incubator management
Technologies
Bioreactors, incubators, automated equipment, ISO 5 biosafety cabinets
Responsibilities
Support development and compliance of manufacturing documentation and policies; oversee daily operational activities and unit operations; maintain compliant and safe operating/storage areas; identify strategic/operational issues and lead corrective actions; coordinate operations project information with Planning, QA, and Supply functions; oversee operators performing unit operations and documentation; assist in setup, commissioning, qualification, and validation of equipment; hire, mentor, and develop manufacturing associates; conduct performance reviews.
Seniority
Manager, hands-on IC with people management