Manager, Operations
Core
Lead strategic and day-to-day operations of sterile formulation, filling, and packaging activities ensuring GMP compliance and operational excellence.
Role type
Senior Operations Manager (Pharmaceutical Manufacturing)
Builds
Sterile pharmaceutical products via aseptic processing and filling lines
Domain
Pharmaceutical manufacturing / Sterile processing
Required skills
GMP compliance, aseptic processing, Lean/continuous improvement, team leadership, cross-functional coordination, risk management, production scheduling
Preferred skills
Six Sigma, new product introduction, process change management, customer/regulatory interaction
Technologies
GMP systems, batch record management, Lean methodologies
Responsibilities
Lead day-to-day formulation and filling operations to achieve safety, quality, delivery, and productivity objectives; Ensure manufacturing activities are performed in compliance with GMP requirements, site procedures, and safety standards; Provide clear direction, coaching, and development to supervisors, leads, and production personnel; Maintain strong floor presence and proactively identify and resolve operational risks and barriers; Ensure appropriate staffing, training, equipment readiness, and material availability to support the production schedule; Review and approve investigations, master batch records, protocols and associated summaries, procedures, risks assessments, change controls, etc.
Seniority
Manager, hands-on leadership
