Project Lead QC

Lead and coordinate QC related project activities for release and stability testing of late-phase (PPQ) and commercial drug products, with a focus on large molecules and Antibody Drug Conjugates (ADCs). Serve as the primary QC representative and project champion, driving project execution through effective coordination of timelines, deliverables, customer engagements, and stakeholder communication in close partnership with Program Managers. Assess laboratory capacity and manage analytical method transfers, ensuring timely implementation of testing to meet customer and project requirements. Implement analytical testing strategies, including method suitability assessments, performance evaluation, control strategies, and specification setting. Author for quality records and cGMP documents e.g. procedures (SOPs) or source documents, reports, deviations, change requests etc. Act as QC subject matter expert during audits, inspections, and customer meetings while ensuring GMP-compliant documentation and regulatory readiness.

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.

• Work experience in a GMP-regulated pharmaceutical Quality Control environment with a sound understanding of analytical testing of biologics (large molecules) is a must.

• You enjoy working with many different people: strong collaboration and stakeholder management skills, with the confidence to coordinate activities, provide constructive challenge, and interact effectively with customers and internal teams.

• Experience in project coordination, analytical method validation and/or method transfer is a strong advantage.

• Fluency in English is a must, fluency in German is a plus.

• Degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related life sciences discipline.