Basel, Basel, Switzerland
Associate Director global MSAT at Lonza Drug Product Services (DPS). • Lead the technology transfer, setup, scale-up and implementation of the technical drug product manufacturing process at the GMP manufacturing site • Responsible for the technical transfer documentation (e.g. gap analysis, risk assessments, manufacturing process description, sampling plan, PPQ protocol/report, etc.) • Alignment within cross-functional teams of SMEs • Project lead for assigned projects (being the customer’s SPOC), organization of project teams with customers and internal and external drug substance sites • Support the generation of regulatory documents • Initiation and managing of change requests. Lead and support critical GMP product / process deviations and corresponding implementation of identified CAPAs • Support inspections and audits of health authorities and customers • Ensure all activities are performed according to current quality, regulatory and health and safety standards • Managing one external CMO (fill and finish and QC activities), including new product introductions, implementation of new processes, process validation, analytical method transfer, timely execution of manufacturing, sample distribution, batch release and shipment to labeling site • Initiation of SOWs, execution of POs, contribution to MSAs in close collaboration with Proposal Management and Commercial Development • Group lead of a team of 4 Technology Transfer Leads
• Responsibility for the production of insulin injection preparations • Build-up of a state-of-the-art aseptic isolator filling unit • Equipment installation qualification and operational qualification • Technology transfer • Validation of compounding and filling processes (including development products) • Ensuring GMP compliance • Staff training • Authoring of SOPs, MBMRs, validation and regulatory documents • Manufacture of clinical drug supplies • Process management and continuous improvement • Subject matter expert in internal and external audits (e.g., FDA, Health Canada and EMA) • Lean management
Technical R&D department • Solid-liquid separation of colloidal particles