Lean Six Sigma Master Black Belt, working since 2005 for lean deployment in pharmaceutical industry. Successfully closed more than 25 projects in manufacturing, quality and outsourcing. Strong experience in root cause analysis and CAPA application. Trainer for Lean Six Sigma management awareness training, Yellow Belt training and Green Belt training. In 2009 responsable for starting Lean Six Sigma deployment at Lonza China. Strong background in analytical chemistry (HPLC, GC, CE etc.) and QC laboratory management.
Expert Committee Member General Chapters Biological Analysis @ Serving USP to develop and approve standards in the field of Biologics and Biotechnology. From March 2015 to Present (10 months) United StatesHead Quality Excellence Biopharmaceuticals, global QA @ Improving business processes and assuring quality and compliance in development and commercial operation of biosimilers by using Lean SixSigma principles. Focus on efficacy and efficiency of deliverables required by GMP regulations. This includes quality control strategies, deviation and CAPA handling process, management of changes, risk management by integrating quality oversight and deliverables to the biosimilar program strategy. From September 2013 to Present (2 years 4 months) Expert Group Member @ Membership in the Expert Committee "Chemistry" of the Swissmedic Pharmacopoeia, working for the Pharmacopoeia Helvetica and European Pharmacopoeia From January 1997 to September 2013 (16 years 9 months) Bern Area, SwitzerlandDirector Quality Excellence @ Designing and implementing a quality improvement program in the scope of an inspection readiness program. From February 2013 to August 2013 (7 months) Expert in Group 11 (natural and semi synthetic products) @ Swiss Delegate for the Group of Experts 11 (natural and semi synthetic products) European Pharmacopoeia From June 2011 to July 2013 (2 years 2 months) Strasbourg Area, Franceglobal Project Manager @ Leading a global project to improve "first time right" within Lonza Biopharmaceuticals...
Root cause investigation and classification in global track wise, human error investigation and classification guidelines, human error prevention. Error proving and redesign of batch records, forms and SOPs, review and update of training systems with a shift of the focus to learning instead of training, process improvement cycle by periodical process reviews using process capabilities and SPC for CQA and CPP to identify gaps and update the control strategy accordingly. Implementing a "living Pareto" in daily operation to collect, trend and act on issues on the shop floor...
Resulting in a reduction in deviations across the biopharma sites by 40% within 20 month. From May 2011 to January 2013 (1 year 9 months) Project Manager LCMB Visp @ Project Leader for a business improvement project for small scale & early stage microbial biopharmaceutical operation, throughput improvement by building a plant extension, SMED activities to reduce change over time. From March 2010 to April 2011 (1 year 2 months) Operational Excellence Director China @ Responsable for the startup of operational excellence in Lonza China in 2009 From January 2009 to December 2009 (1 year) Lean Six Sigma Black Belt @ Black Belt for Lonza Exclusive Synthesis in Visp Switzerland From July 2005 to December 2008 (3 years 6 months) Head QC Pharma LES @ Department Leader for Quality Control in Lonza Exclusive Synthesis,
including responsibilities for GMP compliance, LIMS, Stability programs, reference material management. From January 2000 to July 2005 (5 years 7 months) Analytical Development R&D @ Head of Laboratory; Responsable for method development and validation for gas chromatography and thin layer chromatography, project management for overall analytical aspects during technology transfers and production in mid scale launch plant. From February 1994 to January 2000 (6 years)
Ph D, Chemie @ Universität des Saarlandes From 1984 to 1993 Abitur, Biology, Mathematics and Geography @ Max Planck Gymnasium Saarlouis From 1974 to 1983 Wolfgang D) is skilled in: Six Sigma, GMP, Lean Manufacturing, CAPA, Operational Excellence, Root Cause Analysis, Quality Control, Pharmaceutical Industry, Manufacturing, Black Belt, Supply Chain, Outsourcing, Analytical Chemistry, HPLC, Training