Michael Hudson Email & Phone Number

Responsible for manufacturing DosePro (Needleless Injection device), assembly, aseptic fill and finish/combination product, injection moulding, drug container and machined components.Duties:• Manage cross-functional teams to meet company bottom-line and quality objectives• Technical lead providing internal and external customers with technical, product testing, verification and validation support• Manage product design and risk from design input and post market… Show more Responsible for manufacturing DosePro (Needleless Injection device), assembly, aseptic fill and finish/combination product, injection moulding, drug container and machined components.Duties:• Manage cross-functional teams to meet company bottom-line and quality objectives• Technical lead providing internal and external customers with technical, product testing, verification and validation support• Manage product design and risk from design input and post market information• Lead and support product failure investigations arising from customer complaints and product returns• Validation management of equipment, tooling, inspection and process performance• Budget responsibility for engineering costs, design studies and CAPEX expenditure• Management of deviations, CAPA’s, OOS and 8D reports• Drive process performance using lean concepts and techniques and through automation • Building quality into products and processes through robust testing and process monitoring, audits, quality metrics, continuous improvement, and statistical sampling and process control• Vendor management both in the UK and Germany ensuring robust contract execution to maintain secure sustainable, predictable performance, while strengthening customer relationships Show less

Responsible for technical leadership in design, development, design quality, analysis and risk and troubleshooting.Duties:• Manage process, manufacturing development and continuous improvement projects • Manage design and risk documentation, process descriptions, technical specifications and process models• Define processes for review, analysis and reporting of manufacturing data• Provide technical expertise and support for technology transfer of combination… Show more Responsible for technical leadership in design, development, design quality, analysis and risk and troubleshooting.Duties:• Manage process, manufacturing development and continuous improvement projects • Manage design and risk documentation, process descriptions, technical specifications and process models• Define processes for review, analysis and reporting of manufacturing data• Provide technical expertise and support for technology transfer of combination product• Provide leadership, to ensure delivery of project objectives on time and within budget• Identify project risks and mitigation and capitalisation plans• Manage capacity plans for aseptic manufacturing and component manufacturers Show less

Wrexham

Responsible for facilities, manufacturing, aseptic fill and finish, liquids, ointments, solid dose and validation. Drug product delivery system development and design and installation of manufacturing solutions for combination products.• Manage engineering and validation department• Drive process performance using lean concepts and techniques and through automation • Project management of new build, upgrades, new processes, equipment and validation• Developing team skills… Show more Responsible for facilities, manufacturing, aseptic fill and finish, liquids, ointments, solid dose and validation. Drug product delivery system development and design and installation of manufacturing solutions for combination products.• Manage engineering and validation department• Drive process performance using lean concepts and techniques and through automation • Project management of new build, upgrades, new processes, equipment and validation• Developing team skills and knowledge through training and mentoring• Managing engineering and validation risk and continuous improvement• GxP, risk management, deviations, CAPA and OOS management.• Ensuring control of spend, cost centre budgets and CAPEX expenditure• Component supply development and management in the UK and Europe.• New equipment design from development to commercial scale• Creating project specifications and outlining the scope and resources required to meet company objectives Show less