Basel, Basel, Switzerland
+ 25 years experience in cGMP large scale biotech production processes + Innovative leadership and development of diverse strong performing teams + Passionate about Lean and Agile principles, Right First Time and Continuous Improvement to increase productivity, speed and cut costs + Reputation for entrepreneurial mindset, can-do attitude, creative problem solving and result orientation + Known as a reliable, courageous, motivating, balanced and flexible team member + Unique combination of production level understanding and strategic attitude with focus on servant leadership +
Responsibility: + Setup of end-2-end MSAT (organization, processes, documentation) across 4 European CDMO sites (DS fermentation and DP solids) for manufacturing of Life Biotherapeutic Products for Clinical Phase 1 – III and Commercial + Responsible for process transfers and comparability/validation activities from customers into sites + Set up of Visp Commercial Manufacturing Site (DS and DP), process scale up and improvement, equipment design and CQV support + Acting as user representative in upper 2 digit mCHF CAPEX facility fitout Achievements: + Setup of an agile MSAT team to serve the network and site needs + Process simplifications and cost savings for customers + Visp CAPEX project: In time process equipment selection, cost-adherence and on time risk assessments and validation documents + Establishment of a network technology roadmap and start of a platform standardization for equipment and single use material
Responsibility: + Lead of 12k scale highly automated (MES, PLS) commercial monoclonal antibody drug substance manufacturing facility for two Roche blockbusters + Accountability for critical metrics of the value stream in line with strategic network ambitions + Guidance, motivation and development of about 160 employees + 2 digit million budget and CAPEX responsibility for entire organization Achievements: + Run rate increase of 50% through Lean Production System with only few temporarly additional headcount + Improvement of shift models and line manning to reduce silos and cut workload peaks + Transformation of a team into self-directed mode covering end to end discrepancy handling resulting in 30% efficiency increase + Production lead time reduction through segregation of batch record review and deviation handling responsibilities + CAPEX upgrade of a purification line by inline dilution and separate column packing room
Responsibility: + Leading of CHO cell culture department in 12k scale + Organization, motivation and development of 40 employees + Production of harvested cell culture fluid in accordance with cGMP requirements Achievements: + Implementation and sustainment of LPS in Upstream organization, behavioural change management, efficiency gain, continuous improvement and error-avoidance + Leading change of co-location of QA into all production areas + Lead of Network Unit Operation Team Harvest 2013 - 2016 (with deputies from all sites) + Lead of Site Technology Council (cross functional team responsible for E2E technology strategy, CAPEX planning, and continuous improvement) + Implementation of global Quality- and Manufacturing-alignment program as site-lead
Responsibility: + Management of the Quality Validation and Environmental Monitoring Group (11 FTEs) Achievements: + Hiring and development of the new group at facility startup + Establishment of validation strategy and setup of all validation documentation for new facility + Setup and coordination of Quality Risk Management at Basel Biotech Manufacturing + Driver for cost savings by simplification and merging of multiple Environmental Monitoring Groups in Roche + Establishment of new inspection management (Backoffice, request tracking, communication) + Ad interim Quality Site Head Basel Biotech Manufacturing for 3 months in 2010
+ Realization of a lifetime dream of a journey through the african continent by an old, modified Toyota 4x4 from Basel, Switzerland to Cape Town, South Africa + Trip through 17 countries, different cultures, different environments, 45'000 km and a lifetime experience
Responsibility: + Commercial manufacturing of live bacterial oral vaccines (Typhoid Fever and Cholera) + Responsible for end to end production facility with 15 employees (fermentation, harvest, lyophilization, formulation, capsule- and sachet-filling and capsule-coating) Achievements: + Facility upgrade; Implementation of Cleaning In Place and upgrade of zone concept + FDA Approval of upgraded facility
Responsibility: + Commercial manufacturing of live bacterial oral vaccines (Typhoid Fever and Cholera) + Responsible for Fermentation and Harvest with 10 employees Achievements: + Implementation of new master batch record template + Refurbishement of media prep area
Responsibility: + Conjugation and downstream processing of conjugate vaccines (chromatography, linkage, UFDF, bulk freezing) + Process transfer and scale up of downstream processes