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 clinical 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.
• Provides technical guidance on change controls and how they might impact customer processes.
• Ensures and encourages an Operational Excellence environment
• Develops and report metrics for clients to trend project progress
• 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
• Cooperates with proposal or program manager on drafting/reviewing new proposals and change orders.
• 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
• Involved in regulatory filing