Effective in identifying and communicating operations risks and means to mitigate these risks. Experience in production planning and management.
Project Management: Extensive project management skills, including planning, scenario and contingency mapping. Promotes best practice in relation to capturing, analysis and communication of data to feed into technical decision-making across the company. Problem Solving: Supports a culture of data-driven problem solving that ensure development of efficient processes for manufacturing and testing. 
Provides and implements practical and innovative solutions to difficult technical issues associated with manufacturing.
Technical: Strong technical capability with detailed understanding of technical principles, materials and processes used in the manufacture of medical devices and sub-system. Support audits of SCM and support supplier as required when auditing their supply chain. Technical support to SCM for issue resolutions with component level suppliers. Support implementation of development and commercial supply agreements with SCM. Responsible for the capture of product and project risks and maintenance of risk register. Support and consult on all process validation activities as required. Ğnsure voice of suppliers/SCM is integrated into new design iterations. Implementation of robust supplier performance and monitoring processes. Support key decisions, impacting costs and timelines, with scenario planning to ensure favourable outcomes. Support SCM in set-up of manufacturing and in identifying resource needs. Generation of demand forecast to support clinical studies working closely with suppliers and SCM to ensure demand can be met reliably. Ğnsure sufficient transfer of supply chain and manufacturing documentation to SCM as required as part of scale up activity. ĝevelop project plans, risks, budgets, timelines and resource requirements to facilitate scale up of activity to support increase production for clinical studies. Subsequently in support of technical design transfer Provide project updates to senior management. General project management of all manufacturing activities at sub-contract manufacturer, including communication of instructions to SCM operations. Identify and work with SCM and suppliers to source equipment appropriate to facilitate the robust manufacture of catheter systems, with verifiable processes both for manufacture and inspection. Project manage manufacturing activity at SCM in support of FIH and subsequently scale up for larger clinical studies. Supply Chain management, including qualification and generation of development and commercial agreements. Dmr programming flowchart update#
Update and manage system for stock at both client and SCM site. Execute Change Control for process updates, as required, through DV for FIH. ğreeze manufacturing documentation prior to DV builds. Review and manage updates to all manufacturing documentation: MPIs, DHRs, in-process / manufacturing specs, BOM, Flowchart, DMR throughout DV for FIH, in-line with Change Control. Provide PM and technical leadership for the manufacture of the support catheter system for First-In-Human Clinical studies. Initial responsibilities to support FIH studies Program Manager – R&D New Product Introduction Temporary & Contract Staffing Solutions.
0 kommentar(er)
