A resourceful, quick-thinking, and multi-talented Manufacturing Operations Manager, with a keen interest in the manufacture of in vitro diagnostic devices (IVDs), including instruments and disposable cartridges. A proficient analytical problem-solver with proven experience in manufacturing line C&Q, CMO management, and production challenge troubleshooting. Highly creative, confident, and professional when working under pressure, independently or within a team, across complex multi-disciple projects.IVD Device Manufacturing Significant experience in new product pilot assembly development as well as set-up of fully validated CE-IVD marked product manufacturing line, including assembly station/process requirements, pFMEA, and comprehensive validation activities (I/O/PQ), remotely amidst the CoVID-19 pandemic, against a challenging timeline. These activities also include auditing / reviewing CMOs (across Europe, US, and Asia), leading comprehensive quotation/timeline assessments and engaging in new supplier arrangements (including associated legal / IP ownership considerations and budgetary/ costing negotiations). Experienced in co-ordinating multi-tiered supply chain into on-going production scheduling, tracking production costs and resources, as well as establishing, reviewing, and reporting on manufacturing OKRs and KPIs, and value stream mapping (VSM). Significant exposure to diagnosing production challenges across disposable cartridge assembly and instrument assemblies non-conformances, including implementation and monitoring of corrective actions (CAPA), under ISO 13485. Manufacturing know-how encompassing review of injection moulding tool design and measurement data (FAI/ISIR), laser welding equipment / practices, disposable product integrity testing and inline QC inspection processes, formulation dispensing and lyophilisation, PCB/electronics sub-assemblies, machined components, convergent instrument build, as well as batch manufacturing record (BMR) review and optimisation. A keen eye for OEE review and cycle time reduction strategies to support continual improvement practices.Programme ManagementSubstantial experience in co-ordinating multi-faceted internal R&D teams, alongside management of external CROs, CMOs, & analytical support partners working on complex / heavily integrated projects. Meticulous Gantt/resource planning, expert communication, and diligent activity tracking have proven to be a superb strategy for effective programme management. First-hand experience of building and implementing project/manufacturing management structures.