Sr. Manager, Automation – GTx Lead
Core
Lead automation strategy and operations for next-generation gene therapy manufacturing, ensuring reliable, compliant, and efficient production of drug substances and products.
Role type
Senior Manager, Automation (Manufacturing)
Builds
Automated manufacturing systems and processes for gene therapies
Domain
Biopharmaceuticals / Gene Therapy / GMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
DCS, PLC, SCADA, MES, Historian systems, computerized system validation, change control, CAPA management, root cause analysis, team leadership, regulatory compliance (FDA/cGMP)
Preferred skills
Building Management Systems, CMMS, Microsoft Office, project management, vendor management
Technologies
DCS, PLC, SCADA, MES, Historian, Building Management Systems, CMMS
Responsibilities
Lead design, implementation, maintenance, and support of manufacturing automation systems; drive continuous improvement initiatives; oversee computerized systems for critical processes; lead and mentor automation engineers; establish KPIs for system reliability; manage change controls and CAPAs; lead deviation investigations; serve as SME during regulatory inspections; partner with cross-functional teams for new product introductions.
Seniority
Senior Manager, hands-on IC with team leadership
