Jörg KUBACH

Contractor for COVID-19 Vaccine Project

Responsible for Quality Control and biological Reagents Manufacturing

Responsable for the manufacturing operations of the Cressier/FR Switzerland facility.

LEAN Six Sigma Black Belt & LEAN Instructor; Responsabilities for the deloyment of continuous improvement culture and Operational Excellence; Drive Six Sigma & LEAN Manufacturing initiatives and associated trainings; Manage cross functional improvement projects; Strategic planning process and business metrics for IH Division

Responsible for the Product Life Cycle Management and Quality Projects at the Neuchâtel facility including professional, technical, organizational responsibility and development of technical expertise. Drive applications of quality management and continuous support in product lifecycles and development projects in consideration of compliance with regulatory/company requirements from early product development stages through commercialisation.

Responsible for the Release and the Quality Operations of two API manufacturing lines and one aseptic filling operation. The deployment/application of the Quality Systems in the entire facility including Documentation-, Exception Management and Change Control Systems. ISO 9001:2000 certified

Responsible for all validation strategies and activities including master validation plans, Manufacturing process validation (e.g. mammalian cell culture, purification and aseptic filling), Manufacturing equipment qualification (IQ, OQ, PQ), Cleaning/sterilization validations (COP & CIP/SIP), Critical system qualifications, Computerized system validations, Laboratory assay/method validations. Technology transfers and successful preparation of several submission files.

Responsable for the small/large scale manufacturing of antibody containing cell culture supernatants for the use in invitro diagostic products. Design and technology transfers from the R&D stage and product transfers from other manufacturing sites to the local routine operations. Execution of pilot batches for up- and downstream processes including the preparation of appropriate documentation e.g. batch records/SOPs. Responsible for Safety, Health and Environment of a manufacturing site with 150 employees.