Sam Hyde Email & Phone Number

Brisbane, Queensland, Australia

Brisbane, Queensland, Australia

Brisbane, Australia

As the Downstream Manager I have enjoyed the challenges of leading my team and building on the foundations that I have created as the Downstream Supervisor. In this role I have achieved the following:• Developed a high performing team and maintained an excellent track record in cGMP clinical manufacture.• Developed and implemented strong management tools for production planning and KPI monitoring. This includes an electronic production KPI dashboard with live data feeds pulling from… Show more As the Downstream Manager I have enjoyed the challenges of leading my team and building on the foundations that I have created as the Downstream Supervisor. In this role I have achieved the following:• Developed a high performing team and maintained an excellent track record in cGMP clinical manufacture.• Developed and implemented strong management tools for production planning and KPI monitoring. This includes an electronic production KPI dashboard with live data feeds pulling from multiple systems.• Created and continue to optimise effective procedures and processes to support the team to excel in a cGMP environment in a TGA-licensed facility. Through the development of these procedures and processes, the team has had no major audit or regulatory inspection observations.• Created robust head count models to determine staffing requirements for current operations level through to future capacity models.• Experienced large Capex project proposals and execution, plus supported global projects.• Experienced in all areas of validation and managing the team to support the validation of large complex manufacturing systems.• Strong leadership skills managing conflict resolution and maintaining team alignment.• Knowledge of Thermo Fishers practical process improvement (PPI) system and I am an accredited process manager (PM). I have facilitated 1 Kaizen and been part of over 6 Kiazens.• Created a system to identify and record waste to help prioritise process improvement projects for the Operations group.• Managed and supported cross-functional teams at both site and global levels. Show less

Brisbane Area, Australia

As the Downstream Supervisor I was involved in improving and transitioning the team from start-up to routine manufacturing. In this role I achieved the following: • Attracted and developed key talent in the team to create future leaders within the team.• Developed and implemented strong management tools for production planning. This included the DSP huddle board, and the Operations-level visual production schedule, and cascading production planning schedule.• Established a… Show more As the Downstream Supervisor I was involved in improving and transitioning the team from start-up to routine manufacturing. In this role I achieved the following: • Attracted and developed key talent in the team to create future leaders within the team.• Developed and implemented strong management tools for production planning. This included the DSP huddle board, and the Operations-level visual production schedule, and cascading production planning schedule.• Established a ‘can-do’ culture within the team to allow them to excel with complicated projects.• Successfully managed the team and changed processes through transitioning from a Monday-Friday roster to a seven-day week roster. In this transition I managed multiple challenges in growing and training the team from 7 to 18 staff members in under 12 months.• I developed and implemented effective procedures and processes to support the team to excel in a TGA-licensed facility. • As the subject matter expert (SME) for DSP, I took on the responsibility for Quality investigation. Through this process I identified and implemented necessary CAPA’s and improvement to DSP SOP’s.• Worked with a cross functional team to maintain the compliance of the following processes: cleaning verification and control for multi-use equipment, control of resin, and viral segregation.• Optimised the DSP process through the use of Kanban, standardised room layouts, standard work and shadow boards. Show less

Brisbane, Queensland, Australia

In this role I was involved in the start-up of the biologics facility for DSM. I was involved in the following areas during start-up.• Equipment selection, procurement and validation of multiple systems. • Setup the Media and Buffer Preparation (MBP) department.• Developed the following site systems and procedures: Routing, Segregation, Gowning, and the GMP Facility Cleaning.• Was instrumental in the planning and implementation of the transition of the manufacturing suites… Show more In this role I was involved in the start-up of the biologics facility for DSM. I was involved in the following areas during start-up.• Equipment selection, procurement and validation of multiple systems. • Setup the Media and Buffer Preparation (MBP) department.• Developed the following site systems and procedures: Routing, Segregation, Gowning, and the GMP Facility Cleaning.• Was instrumental in the planning and implementation of the transition of the manufacturing suites from a construction phase to qualified cleanrooms ready for manufacturing. This included the selection cleaning equipment, gowning supplies and a contract cleaning service provider.• Worked with the Supply chain team to create work flows and procedures for the control of material from procurement through to consumption and reconciliation.• Created planning and management tools to aid in production of media and buffers for customised processes.• Created the initial Media and Buffer Production Protocol templates and wrote all media and buffer preparation SOP’s.• Was the initial subject matter expert (SME) for the following: single-use mixing systems, autoclave, single-use weigh and dispense systems, single-use pumping and filter integrity testing. Show less

Brisbane, Australia

Brisbane, Australia

In this role I was managing the day to day running of the BSA production suite. My responsibilities included: • Managing staff workloads, ensuring on time completion of all manufacturing processes and documentation.• Maintaining a high level of GMP compliance and quality record reviews.• Created and managed the production schedule based on sales.• Monitored the production process to ensure yield and quality was maintained.• Liaising with the purchasing team to ensure all… Show more In this role I was managing the day to day running of the BSA production suite. My responsibilities included: • Managing staff workloads, ensuring on time completion of all manufacturing processes and documentation.• Maintaining a high level of GMP compliance and quality record reviews.• Created and managed the production schedule based on sales.• Monitored the production process to ensure yield and quality was maintained.• Liaising with the purchasing team to ensure all raw materials and consumables were scheduled based on production demand.• I was the SME for all production steps including: tangential flow filtration, depth and bioburden filtration, RO water generation, pure steam generation and lyophilisation.I also assisted in other areas of the business including the production of sterile FBS and aseptic filling. This role involved the following production activities: CIP and SIP of the production vessels and filtration train, sterile filtration, manual aseptic filling of >2000 bottles / day, and the packaging and labelling of final product.Achievements:• Increased suite output by 50% without significant Opex or Capex expenditure.• Developed the process flow with a rapid thawing process to improve the product quality for New Zealand-sourced BSA product.• Redesigned the Manufacturing Batch Records to improve the document flow so it was more user friendly for operators. This significantly improved ‘right first time’ completion of records. Show less