Director, Sterility Assurance
Core
Provide global leadership for sterility assurance and contamination control across Lonza's sterile manufacturing network to ensure world-class biological contamination control and compliance.
Role type
Director, Sterility Assurance (Global Strategy & Governance)
Builds
Sterile drug substance and drug product operations
Domain
Life Sciences / Biologics / Sterile Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Sterility assurance strategy, Contamination control, Microbiology, Aseptic manufacturing practices, Quality risk management, Root cause investigation, CAPA implementation, Regulatory compliance (GMP), Cross-site collaboration, Continuous improvement
Preferred skills
Advanced scientific qualifications, Certifications in relevant fields
Technologies
Environmental monitoring, Microbiological testing, Facility design, Process design
Responsibilities
Develop and improve biological contamination control strategies for viral, bacterial, fungal, and mycoplasma risks; Lead global sterility assurance risk assessments and support contamination event responses; Drive harmonization of sterility assurance standards across global sites; Act as global expert for product development and new product introductions; Coach employees on biological risks and aseptic behaviors; Support regulatory inspections and audits as a subject matter expert.
Seniority
Director, Global Leadership