Manufacturing Operations Manager - Lyophilisation
Core
Lead lyophilisation operations to ensure reliable supply of lyophilised vial products for rare disease patients globally.
Role type
Manufacturing Operations Manager (Lyophilisation)
Builds
Lyophilised vial products for rare disease patients
Domain
Biopharmaceutical manufacturing (sterile filling and lyophilisation)
Required skills
Operations management, cGMP compliance, sterile filling and lyophilisation technology, continuous improvement, audit and deviation management, training development, KPI management, health and safety compliance
Preferred skills
Sterile operations management experience
Technologies
Lyophilisation equipment, sterile filling systems
Responsibilities
Lead assigned operations activities including batch filling, loading/unloading, batch turnaround time, and batch release cycle time; Ensure compliance with cGMP regulations (FDA 21 CFR Part 211, EU GMP Annex 1) and safety standards; Monitor GMP compliance through audits, deviations, and document reviews; Develop and lead a continuous improvement program to reduce COGs; Ensure employee training against SOPs and GMP requirements.
Seniority
Manager, hands-on leadership