Manager, Manufacturing Operations
Core
Manage day-to-day operations of a Drug Product Facility (DPF) in a cGMP environment, overseeing staff, processes, and regulatory compliance for pharmaceutical manufacturing.
Role type
Senior IC manufacturing operations manager
Builds
Solid oral dosage forms and drug products
Domain
Pharmaceutical manufacturing / cGMP
Required skills
cGMP compliance, process validation, statistical process control (SPC), technology transfer, scale-up, cleaning validation, batch documentation, CAPA, change controls, team management
Preferred skills
Quality by Design (QbD), Design of Experiments (DoE), complex data analysis, late phase clinical development
Technologies
QDoCCS
Responsibilities
Direct group activities and assign tasks, align with site leadership for technical direction, facilitate process improvements and best practices, perform event investigations and change controls, coordinate maintenance and equipment upgrades, mentor and evaluate team performance
Seniority
Manager, direct oversight and management
