Manufacturing Associate III
Core
Execute cGMP-compliant production activities for clinical and commercial autologous and allogeneic cell therapies, including cell culture, aseptic processing, expansion, separation, counting, and cryopreservation.
Role type
Senior Manufacturing Associate (Cell Therapy)
Builds
Clinical and commercial cell therapy products
Domain
Biopharma / Cell & Gene Therapy
Required skills
cGMP manufacturing, aseptic processing, cell culture, cell expansion, cell separation, cryopreservation, cleanroom operations (Grade A-D), deviation investigations, CAPA implementation, equipment troubleshooting, SOP maintenance, batch record review
Preferred skills
CDMO experience
Technologies
Bioreactors, incubators, centrifuges, electroporation systems, controlled-rate freezers, cell selection platforms, single-use technologies, cell counters, liquid nitrogen storage systems
Responsibilities
Support manufacturing operations for clinical and commercial cell therapy programs; Coordinate daily production scheduling and resource planning; Execute and oversee key manufacturing processes; Assist with development and maintenance of manufacturing documentation; Train and mentor Manufacturing Associates; Lead deviation investigations and CAPA implementation; Drive continuous improvement initiatives; Support validation and qualification activities; Maintain inspection readiness for cGxP and FDA compliance
Seniority
Senior, hands-on IC