MSAT Lead

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.

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

• Proven team leadership experience, including conducting performance discussions and managing performance effectively (experience from MSAT, QA, or Manufacturing environments)

• Strong resilience, with the ability to stay composed and lead under pressure in a demanding and evolving environment

• Demonstrated expertise in sterile fill & finish manufacturing (essential)

• Ability to lead with authenticity and positivity, providing clear direction, perspective, and fostering accountability within the team

• Solid background in MSAT operations, with experience in technology transfer and process implementation (highly preferred)

• Scientific degree (natural sciences) preferred; additional expertise in lyophilization and/or ADC (antibody-drug conjugates) is a strong advantage