• Goal driven pragmatic leader
• Creates and innovative and supporting environment
• 10 years experience in biopharmaceutical process development and production
• 20+ different IMPs brought into preclinical and clinical studies
• Development of commercial process for lead product candidate (industrial scale)
• Lead multidisciplinary international project teams incl. CMOs of intermediates, drug substance, drug product, contract labs, etc.
Core competences:
• Biopharmaceutical process development and manufacture
• Project leadership
• Team leadership
• Quality management (GMP)
• Regulatory – CMC (reg. requirements, IMPD/IND filings, HA meetings, etc.)
• CMO Management
Project Manager New Products and CMC @ Main achievements
• Project costing, timing and revenue analysis for portfolio review and project selection process
• Evaluation of technology transfer for licensed vaccine to newly acquired site From November 2014 to Present (1 year 2 months) Technical Project Leader @ Main achievements:
• Strategic project planning across the departments.
• Leading the transition of the CMC unit to be run as a virtual biotech company.
• Transfer of process to CMO as redesign for phase 3 clinical production and in-market supply.
• Leading an international project team in a matrix organisation.
• Development of product towards a 4 year shelf life in prefillable syringes.
• Design of a product comparability study and assurance of regulatory acceptance thereof.
• Design and control of unit budget and spending’s. From May 2013 to November 2014 (1 year 7 months) SwitzerlandHead Life Science Technologies @ Main achievements:
• Member of the executive board.
• Establishment of the Life Science Technology department as a key unit for Advens.
• Transition of the unit to new management (by Alpiq).
• Establishment of new business development source for project acquisition in China. From April 2012 to April 2013 (1 year 1 month) Winterthur Area, SwitzerlandProjektleiter Pharma/Biotech, Business Development Pharma/Biotech @ Main achievements:
• Market analysis with focus on business expansion in the emerging markets
• Definition of business strategy of unit with support of the mother house
• New projects acquired in China and Switzerland. From October 2011 to April 2012 (7 months) Winterthur Area, SwitzerlandHead Process Development and Production @ Main achievements:
• Successful delivery of material for proof of concept study for external research collaboration partners.
• Process design and manufacturing of complex conjugate vaccines.
• Market analysis and preparation of unit for management buy-out.
• CMC responsible during due diligence From December 2010 to September 2011 (10 months) Manager Process Development @ Main achievements:
• Structuring and education of the members of the unit after company reorganization. From September 2010 to December 2010 (4 months) Technical Project Leader @ Main achievements:
• Project planning across all departments
• Company representation during scientific advice with regulatory authorities
• Technology Transfer to licensee From September 2005 to June 2009 (3 years 10 months) Group Leader @ Main achievements:
• Bringing > 10 product candidates (VLP based products) into clinical and clinical trials (process development and production)
• GMP production of > 20 batches
• Creation of an excellent working environment for the group, leading to an outstanding group performance
• Co-authoring of > 20 clinical trial applications
• Reliable and high quality sourcing of critical raw materials (haptens, peptides, oligonucleotides) From June 2003 to June 2009 (6 years 1 month) Engineer @ Main achievements:
• Hands-on production of the first clinical GMP batches of Cytos ImmunodrugsTM. From June 2002 to June 2003 (1 year 1 month)
CAS, General Management @ Universität Zürich From 2008 to 2008 Chemiker FH, Chemie @ Zürcher Hochschule Winterthur From 1997 to 2001 Berufsmatura, Technisch @ Berufsmaturitätsschule Zürich From 1996 to 1997 Laborant, Organische Chemie @ Eidgenössische Technische Hochschule Zürich From 1993 to 1996 Matthias Kinzler is skilled in: Biotechnology, Technology Transfer, GMP, Biopharmaceuticals, Leadership, Pharmaceutical Industry, CMC, Process Engineering, Lifesciences, R&D, Drug Development, FDA, Comparability, Biotechnologie, Technologietransfer