Value Stream Manager – Cartridge Filling
Core
Lead manufacturing activities for the development, scale-up, validation, and commercial launch of a sterile cartridge filling line.
Role type
Senior manufacturing operations manager (sterile/aseptic)
Builds
Sterile cartridge filling line for new product commercialization
Domain
Healthcare / Pharmaceutical manufacturing
Required skills
sterile manufacturing operations, aseptic processing, GMP compliance, team leadership, process validation, equipment commissioning, risk management (FMEA), regulatory inspection support
Preferred skills
Annex 1 knowledge, new product introduction experience, technology transfer experience
Responsibilities
Lead manufacturing activities for development, scale-up, and commercial launch; Ensure manufacturing readiness for PPQ and commercial production; Support equipment FAT, SAT, and qualification; Contribute to risk assessments and quality risk management; Build and develop a manufacturing team; Ensure compliance with GMP and aseptic standards; Review manufacturing documentation for accuracy.
Seniority
Senior, hands-on IC with team leadership
