Neuchâtel, Switzerland
Biopharma leader with 14+ years of experience making complex processes simpler, safer, and more reliable. I’ve helped bring life-saving therapies to patients by leading technology transfers, boosting yields, and driving regulatory approvals. I bridge the gap between science, quality, and business: managing global partners, solving tough problems, and ensuring every process runs smoothly from lab to large-scale production. Curious by nature and driven by impact, I thrive on turning challenges into opportunities and making sure patients get the treatments they need.
- Lead the Virtual Plant Team and be the interface with external manufacturing functional area (MS&T, Quality, Supply chain, Procurement, Finance) - Manage interactions and negotiations with Contract Manufacturing Organizations (US, Singapore) - Responsible for CMO Operation performance monitoring & reporting, Tier escalation and reporting for high impact events - Ensure compliance with contractual terms, (Master Service agreement, Scope of Work, Quality Agreement) - Support on forecasting, production planning and supply chain business process activities to ensure continuity of supply and avoidance of back-orders - Primary point of contact for communications and resolution of supply chain and technical issues that may impact timely supply of product and/or contractual obligations - Establish spend budgets for assigned manufacturing site and the associated variances - Define and execute risk management strategies and contingency. Keep the External manufacturing risk register up to date
- As the Validation subject matter expert (SME), oversight of both systems and execution of process validation as well as ancillary validation studies for a recombinant Drug substance manufacture including Upstream, Downstream and Media &Buffer processes - Established and continued updating the quality management system elements (SOPs, Forms, others) governing process and cleaning validation and ancillary validation studies, such as mixing validation, process hold times and resin lifetime validation. - Accountable of the validation strategy with an emphasis in risk-based, science- based approaches to Process Validation and responsible of the timely preparation of supporting risk analysis (FMEAs), process validation study protocols, sampling plans and validation reports - Contributed to the writing of briefing book for FDA Type C meeting preparation describing process validation approach as part of the foreseen regulatory submission. - Supported the generation of study plans from MSAT (Manufacturing Science and Technology) governing the start-up phase of the facility project - Building of a project schedule - including associated validation resource and material estimates and addressing the time point and the duration of process and cleaning validation activities during the start-up and Engineering Run phases - Acted as a Subject Matter Expert for process validation as well as a primary point of contact for customers' requests on process and cleaning validation and represented validation in cross functional Tech Transfer Teams - Interacted with other sites validation teams through the global team, participated to global validation strategy definition and implementation, ensuring aligned approaches and knowledge exchange management
- Responsible for the validation concept in regard to process validation, cleaning validation, ancillary validation studies and continued process verification - Developing process validation master plan, Process Risk Assessments using Quality By design concept - Responsible creation of process validation protocols - Supporting the cleaning validation grouping approach and acceptance criteria definition - Works collaboratively with all our stakeholders like Production, Qualification, Engineering, MSAT, Quality Control in order to drive the creation of the validation schedule and sampling plan, ensuring that cleaning validation and process validation activities are planned, coordinating and executed in an efficient time frame - Providing support to other departments like coaching on deviation investigation or providing inputs to commissioning and qualification documents - Acting as QM Validation counterpart for the Laboratory Management System implementation - Performing review and approval of process development protocols - Management of junior engineers and contractors inside QM Validation team