Luke Coxon Email & Phone Number

Liverpool, England, United Kingdom

Aubagne, France

Northern Europe

Fluid management technologies application specialist.

A technical project management role within the primary and secondary areas of a high-volume GMP manufacturing environment. Managing small teams of experts (5-6 FTEs) and their activities through all phases of the project life-cycle, including:Development of the Work Breakdown Structure and project schedule using MS Project.Generation and management of a risk register.Coordination of project documentation. Stakeholder management.Project finance and budget control up to a… Show more A technical project management role within the primary and secondary areas of a high-volume GMP manufacturing environment. Managing small teams of experts (5-6 FTEs) and their activities through all phases of the project life-cycle, including:Development of the Work Breakdown Structure and project schedule using MS Project.Generation and management of a risk register.Coordination of project documentation. Stakeholder management.Project finance and budget control up to a working budget of £60k.Utilising SAP to control MRPCoordination of Clinical Manufacture/Release:Project Managed the manufacture, transportation and release of H1N1sw clinical material, delivering on time, in full. This allowed clinical trials to commence in 2 separate geographical locations and supported Novartis in achieving first to market for the pandemic vaccine. In addition, managed multiple strain changes to ensure the highest yield possible.Working to extremely aggressive timelines in a rapidly changing environment.Planning and expediting the regulatory pathway.Coordination of Fill/Finish and sample transportation activities at overseas facility.Implementation of single-use solutions:Project management and technical transfer of sterile disposable process consumables (transfer sets/BioProcess Containers/filters/process fluids) required to support an industrial scale manufacturing operation in a state-of-the-art facility.Process engineering.Supplier management/supply logistics.Aseptic operations.Process validation (gamma sterilisation).Scale Up/Optimisation of Manufacturing ProcessWorked closely with other project managers to manufacture clinical material according to an optimised manufacturing process that was demonstrated to deliver >40% yield increases. Introduction and validation of new technology. Change management.Coordination of activities in a cleanroom manufacturing environment. Show less

Vocational Qualifications: VQSET Laboratory and Associated Technical Activities (LATA) NVQ Lvl 2Supervisor in a QC laboratory coordinating the activity of 2 analysts to test, document and release primary and secondary packaging materials to support aseptic filling and fast-moving packaging lines.Responsibilities include:Liaising with site Packaging Technologist to develop novel packaging solutions.Maintenance and control of procedures/protocols/worksheets used in the… Show more Vocational Qualifications: VQSET Laboratory and Associated Technical Activities (LATA) NVQ Lvl 2Supervisor in a QC laboratory coordinating the activity of 2 analysts to test, document and release primary and secondary packaging materials to support aseptic filling and fast-moving packaging lines.Responsibilities include:Liaising with site Packaging Technologist to develop novel packaging solutions.Maintenance and control of procedures/protocols/worksheets used in the testing and release of material.Use of SAP to control the release of suitable packaging material.The validation/calibration/use/maintenance of analytical measuring equipment used in the Component Testing and Analytical Chemistry laboratories.Application of GLP and GMP.Coordination and collation of results from samples sent to other departments for supplementary testing.Internal/external auditing of other departments/suppliers to ensure compliance with regulatory authorities.Compiling reports and performing thorough investigations into out of specification and atypical results using appropriate analysis tools.Generating and monitoring of KPIs to challenge and improve departmental performance.Excellent housekeeping coupled with 5S.Thorough understanding of statistical process control.Additional responsibilities:Qualified risk assessor (COSHH/DSE/manual handling).Sterilisation expert (autoclaves). Show less

Sciences Bsc

Biology Chemistry Mathematics; General Studies

Foundation, Chemistry And Biology