Global MSAT Drug Product Qualification and Validation Lead

Lead global process control strategy for drug product manufacturing. Own global strategies for equipment qualification (PQ), process validation (PPQ), and continued process verification (CPV). Define and govern global SOPs, standards, templates, and tools aligned with regulations and best practice. Own qualification strategy for key unit operations: thawing, compounding, filling, lyophilization, and crimping. Guide Tech Transfer and local MSAT teams on validation strategies, scale‑up, and sampling plans. Review and approve validation documentation; analyze production data using appropriate statistical methods. Act as subject‑matter expert during health authority inspections on validation and CPV/OPV.

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.

• Ph.D. in pharmaceutical sciences, engineering, biochemistry, or related field; or equivalent experience

• Expertise in equipment qualification for aseptic drug product manufacturing

• Extensive experience in process validation for sterile biologics, including lyophilized and liquid formats

• Proven experience with regulatory submissions and pre‑approval inspections

• Strong statistical skills for qualification, validation, and CPV; Data Science certification or Lean Six Sigma Black Belt preferred

• Knowledge of risk assessment, deviation management, change control, and root cause analysis

• Excellent English communication, documentation, leadership, and cross‑functional collaboration skills