Dr. Martin Bertsch

Manage, develop and lead a Team responsible for: GMP Support (Quality Risk Management, Inspection Management, Docu-Center) Business Support (Strategy deployment, Project Management, Change Management, Business Planning, Operational Excellence) Training and Learning Lean Manufacturing Process Implementation and Optimization

Lead Basel site team overseeing European and Asian DP CMO management engaged in the production of liquid and lyophilized sterile drug products (antibody drug conjugates, cytotoxic, highly potent, biologics and small molecules)

Lead team of site managers overseeing process technology transfer, business activities and commercial operations for European contract manufacturing network engaged in the production of liquid and lyophilized sterile drug products (antibody drug conjugates, cytotoxic, highly potent, biologics and small molecules)

Site manager overseeing process technology transfer, business actvities and commercial operations for European CMOs engaged in the production lyophilized sterile drug products (antibody drug conjugates, cytotoxic, highly potent, biologics).

Head of manufacturing department for liquid sterile products (vials and ampoules). Responsible for pharmaceutical product supply, incl manufacturing of generics . Responsible for a team of > 230 FTE operating in a lean, process oriented organisation with all functions to support manufacturing (planning & supply, purchasing, quality, engineering, HR, finance, MES) embedded

Leading of several technical development and supply teams in a matrix organization and representing technical development in global project teams. Responsible for all technical development aspects of product's global life cycle from clinical candidate selection until launch for biotech and small molecule projects. From 2008 on also responsible for all license-in projects from Chugai (Japanese member of the Roche group)

Directed the sterile filling and optical inspection of 120 million glass ampoules per year. Managed, developed and coached 5 exempt professionals and 60 pharmaceutical operators. Implemented continuous improvement initiatives and refined product flow concepts. Managed an annual expense budget of 18 million CHF. • Startup and establishment of Roche’s first high speed filling line with isolator technology. • Increased productivity of the filling lines by >25% in one year. • Accomplished the transfer of s

Managed the galenical technical registration department. Responsible for 5 pharmacists and 1 assistant. Established quality assurance and strategic consistency within the team and gave specific guidance and information to production and international project teams about regulatory guidelines and their interpretation with regard to galenical aspects. • Developed and implemented a global change control commission in order to assess planned process changes for bulk specialities

Stabilization of solutions