Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Our QC PPQ lead exhibits advanced level of knowledge in CGT specific technologies and ensures the timely completion of QC deliverables in light of project PPQ and commercial readiness in accordance with regulatory/compliance requirements and Lonza standards. This function requires a good collaboration with other internal and external parties and departments like MSAT, manufacturing, QA, RA
• Leads the project from an assay and analytical point of view from clini cal phase into PPQ and commercialization.
• Drives independently analytical validations and continued analytical support as per agreed timeline in close collaboration with internal and external parties
• Ensures the compliance, the regulatory requirements and the process of PPQ and commercialization is well understood, as well as analytical control strategy, risk assessments and ensures PPQ and analytical validation protocols and reports are in place.
• Ensures transparent and timely communication to manager on the risks, challenges, issues and actively participates in resolving the issues
• Actively participates in troubleshooting and serves as investigation lead in analytical deviations and investigations related with analytical validations and PPQs.
• Keeps current with advances in cell and gene therapy field, as well as with regulatory guidelines related with CGT PPQ and commercialization.
• Ensures full adherence to the in-house procedures for all activities performed by him/her
• As analytical lead strongly collaborates with process -counter parts on driving the project through PPQ into commercialization
• Pro-actively provides guidance and mentorship to junior members of the team • Manage technical training programs to improve knowledge of QC department on cell and gene therapy and applicable technologies
• Pro-actively establish new ideas, required procedures and tools within QC
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.