Cologne, North Rhine-Westphalia, Germany
I am Dr. Michael Komenda, an entrepreneurial and long-term manager with extensive experience in the pharmaceutical industry. My focus is on research & development, technology transfer and the successful management of complex projects. I understand how to drive compliance and digitalization as well as ensure efficiency and business continuity in the long term. I am known for my straightforward, value-oriented management style and the ability to form and continuously develop high-performance teams. My strength lies in the structured analysis and implementation of processes, always with a clear view of the overarching corporate goals. Focus areas • Strategic management and organizational development • Research & development (R&D) and technology transfer • Complex project management and process optimization • Customer-oriented project acquisition and implementation (CDMO area) • Digitalization and implementation of IT systems (LIMS, GMP-compliant documentation systems) • Appreciative, goal-oriented team leadership and change management
Management & Budget • Disciplinary management of 60 employees, budget and personnel responsibility in Analytical Development Project acquisition & customer support • Successful acquisition of new customer projects and scientific representation of the company with development partners Process and structural improvements • Introduction of optimized interfaces between R&D, business development and project management • Harmonization of workflows and reduction of CAPEX and OPEX • Streamlining of the GMP system Digitization initiatives • Phase I: Implementation of a template-based, GMP-compliant documentation system • Phase II: Introduction of an R&D-wide LIMS, software selection, design and implementation • Preparation for Phase III (paperless data flow) through early LIMS integration of new devices Global site management • Integration of the new development site in the USA into the global R&D organization, establishment of a central, customer-oriented acquisition process Mission Critical Projects • Management of PFAS project incl. business continuity strategy, material stocking and customer communication
Management & Budget • Disciplinary management of > 30 employees in analytical and formulation development • Harmonization of procedures and interdiscuplinary collaboration with company locations worldwide Product focus • Focus on the transdermal patch Neupro® Site management • Independent management of the development satellite site in Monheim with reporting line to the headquarters in Belgium Achievements: • Successful reformulation and relaunch of Neupro® on the US market and conversion from cold chain to room temperature stable product in Europe
Integration projects • Introduction of new structures after the merger with UCB, staff reduction while ensuring operative capability Management & Budget • Disciplinary management of > 40 employees in analytical development Quality management • Introduction of quality and performance-oriented KPIs, transfer of project activities to other sites, head of quality control (§14 AMG)
Team building & management • Disciplinary management of 6 employees in substance analysis Project responsibility & achievements • Drug subtance analytics in the NCE project Fesoterodine/Toviaz® up to global approval • Co-inventor of relevant patents (EP2029134B1, US20130296423A1) Quality systems • Optimization of validation of computer-aided systems, audit preparation (FDA, other authorities)
Research projects • Measurement of biogenic volatile organic compounds as part of the third-party funded project “ECHO” Permanent representation of the project coordinator • Logistical and experimental planning, data interpretation Teaching • Supervision of internships, diploma theses and one dissertation