Csaba Megyeri

Through the past 3 years Soneas tripled production output generating huge volume of waste which dramatically increased waste handling cost and generated business continuity risk due to lack of effective waste treatment processes. In this burning situation the owner and top management charged me to manage this area and establish effective procedure for waste materials.

• In this role I was responsible to take over technology transfers from internal or external R&D department/companies and scale up, optimize the process typically in 10-100 kg batch size for future big scale production facilities internal or external. The plant operates according to GMP conditions. I had full responsibility for manufacturing operations, maintenance, waste management within the approved operation and investment budget. People management was also my part with support of HR department. I had daily contact with internal, external R&D experts, project managers, client representatives to track operations and project progress discussing deliverables quantity and quality aspects as well.

• As Production leader I was responsible for production of 25 different antigen production and 11 vaccines from the very beginning of the process through fermentation process till final sterile formulation and filling process. The products are manufactured in three manufacturing units: bioreactor, fermentation and formulation/filling unit following the technology. I was leading 89 people including operators, technicians, group leaders, unit leaders, experts, support and development manager, trainer, assistant, maintenance team, quality team. Beside delivering actual year production plan and managing routine operation in GMP environment I was also responsible for long term strategic planning and supporting investment projects and new product transfers. Paralely I took part in several investment projects representing my manufacturing area delivering user's requirement, process knowledge, experience, technical needs, giving inputs for best practice. There were two investments to install new plants for new products (Mycoplasma antigene based on fermentation technology, PCV2, PRRS, FLU antigenes based on bioreactor technology), and also reconstruction of existing one to prepare it to be capable to process new products transferred from other plants (Erysipella antigene) or developed by R&D. I took part regular project meetings to control the progress of the projects and reported to the top management. These products were developed to final product forms, sterile vaccines. The focus factory has an individual complete budget which is made by the input of the focus factory manager and prepared by the central financial department. Long term (10 years) capex planning and 5 years head count / recruitment planning were also part of my tasks. I represented my area on the following major regular forums/meetings: Tier meetings, Monthly Performance Meeting (following KPIs), Task Force Meeting (managing on hot topics), Project Meeting, Transfer Meeting, Supply Meeting, Quality Meeting. My major support functions were the following: central quality (standard instructions), central technical department (financing process, small capexes, central energy supply), Global Industrial Department (new product transfers, operational support), Research&Development Department (internal developed new products), HR and Purchasing.

• Leading 103 people in 5 production areas operating in various pharma technologies, warehouse and operation support team. Full responsibility for manufacturing processes of multiple APIs. Major KPI is to deliver annual released production volume on time following batch to batch allocation to customers. I managed operation of manufacturing units, maintain good technical condition of the process areas. I had to ensure the required human resource for the operation and also managed development, training of the staff. Financial budget responsibility. Capex (investment) activities and OPEX control. Responsible for GMP and EHS compliance in production. Regular organizational review and development activities. Working in global environment with cross site functions. Regular reporting to headquarter and representing production function via global calls. Regular negotiations with customers typically about delivery challenges or contract, product quality challenges and major change control clarifications. Intensive development and improvement (CI/Lean) activities to support operation effectiveness. During this period I managed two major investments (based HPLC chromatography technologies) which ensured to implement two new products successfully. These investments cost several Euro millions, installing new technologies and equipment to the site. These new technologies are complete ones starting fermentation, then purification steps finally final handling steps including for example Liofilization. Implementing these new technologies were a big challenge as we had to implement new processes which were unknown for us, but cooperating with R&D team based on their lab experiences we could successfully implemented them.