PROFILE EXPERIENCE HEAD QUALITY CONTROL LEGACY PHARMACEUTICALS SWITZERLAND GMBH | MAR 2013 - CURRENT • Official duties acc. to EU-GMP as ‘Leiter Qualitätskontrolle’. • Reorganisation of QC to team leader structure. • Introduction of current GMP standards in QC. • Driving an Operational Excellence initiative throughout QC. • Implementation of 5S as common work practise. • Substitution of old databases/work procedures/DMS. • Implementation of new Quality Systems (paper based or electronic). • Leading a long term project team (new API manufacturing route). • Auditing function: Internal/external audits as lead auditor (dept./suppliers), representative in case of audits/inspections by customers/authorities • Direct contact of world-wide authority requests. • Experienced in chemical API/biologics/finished products/steriles. • Responsible for equipment acquisition and qualification status. HEAD OF METHOD VALIDATION QA DOTTIKON EXCLUSIVE SYNTHESIS AG | JAN 2011 - FEB 2013 • Coordination and accomplishment of analytical method validation projects (cGMP). • Transfers of methods into routine use for regular production. • Customer support and project management of various projects (up to CHF5M). • Expertise on stability studies (ICH). • Various autonomous projects with major pharmaceutical players. • Replacement of LIMS and time recording system in various functions. HEAD OF R&D CHROMATOGRAPHIC COLUMNS METROHM AG | FEB 2006 - FEB 2008 • Development of stationary phases for IC including market release. • Development of auxiliary equipment for LC. • Implementation of new division into Metrohm AG. • Management of development projects. • Upscaling of newly introduced production processes (ISO 9001). • Contact for world-wide key account manager. • Single point of contact for projects run at universities/research centers. TEAM LEADER VALIDATION&STABILITY STUDIES QC DOTTIKON EXCLUSIVE SYNTHESIS AG | MAR 2008 - DEC 2010 • Coordination and accomplishment of stability studies (ICH). • Supervision of analytical method validation activities (cGMP). • Troubleshooting support for production campaigns. • Customer service for all technical questions. • Implementation of new department. EXPERTISE Compliance GMP Leadership Project Management CMO (API/FP) DR. MICHAEL THEIS Head Quality Control CONTACT A: Stirnrütistrasse 56, 6048 Horw (LU), Switzerland E: [email protected] P: +41 79 171 8275 As chemist phd Michael Theis brings a strong chemical background along as well as an extraordinary intention in leadership, change management and creative ways of solving challenging situations within a regulated environment. He does have the ambition to keep a superior overview of complex procedures and is capable of keeping focus in challenging situations. PROFILE DETAILS Born 4th April 1977 (Wiesbaden) Married, one son