Manager, Manufacturing Technical Operations
Core
Lead Manufacturing Technical Operations to support CGMP manufacturing of gene therapies, viral vectors, and vaccines, ensuring operational success, quality results, and compliance.
Role type
Manager, Manufacturing Technical Operations (IC)
Builds
Advanced therapeutic products (AAV, viral vectors, vaccines) and manufacturing operations support
Domain
Biopharma / Gene Therapy / CGMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CGMP operations, FDA regulations, deviation investigations, Corrective and Preventive Actions (CAPA), Change Controls, operational excellence, technology transfer coordination, document management, bill of materials management, data analytics, finite scheduling, team leadership, performance management
Preferred skills
Equipment operation (incubators, bioreactors, filtration skids, chromatography, mixers, testing equipment), Catalent internal leadership program experience
Technologies
CGMP systems, manufacturing execution systems, data analytics tools
Responsibilities
Build and manage the Manufacturing Technical Operations group; oversee daily activities including investigations, deviations, and CAPA; coordinate continuous improvement and operational excellence initiatives; support technology transfer teams; manage document generation, BOM, scheduling, and suite readiness; coach team members on client interactions and performance.
Seniority
Manager, hands-on IC with team leadership