MSAT Lead 80-100%

The actual location of this job is in Stein, AG, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. Lead a high-impact MSAT team through a demanding CAPEX growth project ramp-up—driving Performance Qualifications (PPQs), aseptic process simulations (media fills), and equipment/process qualifications (PQs) for sterile fill & finish lines, supporting technology transfers, and ensuring successful operational readiness. Build accountability, manage performance, deliver under pressure, and shape a resilient, future-ready culture. This is a fully site-based role. Working together in person supports close, real-time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

• Lead and develop a high-performing MSAT organization responsible for facility ramp-up, process implementation, technology transfers, aseptic process simulations (media fills), process performance qualifications (PPQs), and lifecycle process support.
• Provide full people leadership responsibility, including talent development, performance management, succession planning, and organizational design.
• Foster a culture of accountability, empowerment, innovation, resilience, and continuous improvement while ensuring effective utilization of personnel, equipment, materials, and facility resources.
• Own the technical implementation and qualification strategy for manufacturing processes within the facility, ensuring compliance with Lonza standards, customer requirements, GMP regulations, and industry best practices.
• Drive successful execution of process qualifications, validation activities, and operational readiness milestones to support commercial manufacturing.
• Ensure inspection readiness at all times and serve as a key representative during regulatory inspections, customer audits, and due diligence visits.
• Present technical strategies, validation approaches, process performance, and investigation outcomes to customers and health authorities with confidence and credibility.
• Partner with Operation and Engineering teams to define and deliver strategic priorities, operational objectives, and long-term capability development plans aligned with site, business unit, and corporate goals.
• Contribute actively to the overall leadership and performance of the site.
• Collaborate across functions and sites including Operations, Quality, Engineering, Validation, Process Development, Analytical Development, Regulatory Affairs, and Global MSAT to ensure seamless technology transfers, robust process control strategies, and successful commercialization of new products.
• Act as deputy to the Head of Drug Product Operations Stein as required.
• Establish and continuously improve MSAT standards, systems, and processes, including qualification and validation strategies, single-use technologies, process monitoring, continued process verification, and lifecycle management.
• Ensure application of scientific and risk-based approaches to process design, qualification, and optimization.
• Lead complex product and process investigations, deviations, CAPAs, complaints, and troubleshooting activities.
• Apply strong scientific, engineering, and statistical expertise to analyze data, identify root causes, assess process capability, and implement sustainable corrective and preventive actions.
• Serve as technical authority for manufacturing science and technology, providing expert support and coaching to scientific, technical, and production teams.
• Drive knowledge sharing, innovation, and continuous improvement to enhance process robustness, operational excellence, and product quality.