Senior Manager, External Manufacturing
Core
Drive day-to-day execution, operational readiness, and performance across a Contract Manufacturing Organization (CMO) network to ensure compliant product manufacture.
Role type
Senior Manager, External Manufacturing (Operations Lead)
Builds
External manufacturing activities at CMO/partner sites
Domain
Biopharmaceutical manufacturing / Contract Manufacturing Organization (CMO)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP manufacturing operations, supplier management, batch scheduling, technical transfer activities, validation plans, continuous improvement, site inspections, shipping/packaging compliance, investigations, team management, metrics analysis
Preferred skills
MBA
Technologies
None stated
Responsibilities
Ensure product manufacture occurs in compliance with cGMP and applicable regulations; Facilitate all External Manufacturing activities at CMO/partner sites; Ensure timely routing/review of technical transfer activities, validation plans, MRs, SOPs; Implement site initiatives in production operation; Lead continuous improvements, system implementations and/or strategy development; Ensure off-site inspections, testing and shipping/packaging is done according to guidelines; Support investigations which concern External Manufacturing or associated shipping operations; Manage direct reports and/or lead a sub-team in continuous process improvements; Assist in developing metrics to analyze department activities, workload and performance
Seniority
Senior Manager, hands-on IC with team leadership