Manufacturing Senior Manager, Drug Product Aseptic Filling Operation
Core
Leading the startup of a state-of-the-art aseptic manufacturing facility, overseeing production lines, equipment, and utilities to ensure compliant execution of critical aseptic processes.
Role type
Senior Manufacturing Manager (Drug Product Aseptic Filling)
Builds
Aseptic manufacturing operations for new drug products
Domain
Pharmaceutical manufacturing (CDMO)
Required skills
Aseptic process execution, SOP development, team leadership, NPI management, regulatory compliance (cGMP), equipment qualification, QMS management, client interface
Preferred skills
CDMO environment experience, audit experience, multicultural environment experience, Master's degree or MBA
Technologies
SAP, isolators, lyophilizers, stoppers, capping machines
Responsibilities
Develop and own standard operating procedures (SOPs), lead high-performing teams for efficient day-to-day operations, oversee New Product Introduction (NPI) and technology transfer, support installation and qualification of new manufacturing equipment, ensure adherence to quality standards and client requirements, collaborate with Engineering and Maintenance for equipment calibration and validation, interface with clients for technology transfer and process validation
Seniority
Senior, hands-on IC with people management
