Hilden, North Rhine-Westphalia, Germany
Apotheker und Senior Manager mit mehr als 20 Jahren Erfahrung in der pharmazeutischen Industrie. Tätig in verschiedenen Bereichen - darunter als Chief Operating Officer, Leiter einer Business Unit, Director Operations, Leiter der Qualitätssicherung, Sachkundige Person, Director Project Management, Leiter der Stabilitätsanalytik, Leiter der Zulassungsabteilung und Leiter eines Forschungs- und Entwicklungslabors. ▪ Effizienter Aufbau/Umbau von Organisationseinheiten ▪ Erfolgreiches strategisches Investitionsmanagement, Organisations- und Geschäftsentwicklung. ▪ Erfolgreiche Leitung internationaler B2B-Projekte. ----------------------------------------------------- Pharmacist and Senior Manager with more than 20 years of experience in the pharmaceutical industry. Worked in several fields including functions such as Chief Operating Officer, Head of Business Unit, Director Operations, Head of Quality Unit, Qualified Person responsible for batch release, Director Project Management, Head of Stability Analytics, Head of Regulatory Affairs, leader of a research and development lab. ▪ Efficient development and restructuring of organizational units ▪ Successful strategic and financial/capex management, organizational and business development ▪ Successful leadership of international B2B projects
Als Mitglied der Geschäftsleitung verantwortlich für die Funktionsbereiche Produktion mit Lager & Versand, Produktionsplanung und -steuerung, operative Qualitätskontrolle und Betriebstechnik an beiden Standorten (Hilden und Bonn). Sachkundige Person gem. §15 AMG As a member of the Executive Board, responsible for the functional areas of production with warehousing and shipping, production planning and control, operational quality control, and industrial engineering at both sites (Hilden and Bonn). Qualified Person acc. to §15 AMG.
▪ Responsible for the overall operational business of the newly established BU Pharma & Biotech covering leadership of the departments Production, Supply Chain Management, Engineering, R&D, Project Management, Quality Control, Quality Assurance ▪ Managing a growing team of currently 50 members of which all leading personnel of above mentioned departments are direct reports ▪ Project lead of several extension projects
▪ Greenfield development of a new pharmaceutical Business Unit Pharmasolid / Pharmafluid including establishment of production and QC premises and equipment, development of the pharmaceutical quality management system, development and structuring of the organization ▪ Successful obtainment of the manufacturing authorization for Human Medicinal Products for the site ▪ Development and leadership of the Business Unit covering the functional areas Pharmaceutical Production, Quality Control, Quality Assurance, Product Development and Engineering; personnel responsibility for a team of 40 members ▪ Achievement of status as critical supplier during COVID-19 pandemic: Initiation and execution of the fast-track process development and ramp-up of production capacities to provide required amounts of essential ingredients for the manufacture of COVID-19 vaccines
Steering of all manufacturing and logistics activities of tesa Labtec GmbH at Hamburg plant. Compliance of all operational activities with current legal requirements for the manufacture, storage, and distribution of medicinal products (EU and US Guidelines) and medical products. Fullfilment of legally required duties and functions as 'Head of Production' according to AMWHV and EU GMP Guideline. Member of Board of Management.
Successful establishment, structuring and management of the Advanced Projects Department, responsible for all transfer and contract manufacturing projects of the company from scale up / transfer to market launch. Managing the functional areas of project management, product and technology transfer, scale up and process development, regulatory affairs and stability analytics of transdermal, topical, and mucoadhesive patches as well as oral dissolvable films. Responsible for strategy development, portfolio management, project controlling. Qualified Person acc. to §14 German Drug Law. Member of Board of Management.
Multidisciplinary management (project lead) of several international development projects. Supervision of formulation development team, design of manufacturing processes. Responsible for planning and evaluation of process validation, stability programs, coordination of clinical studies, and writing of CMC sections for registration dossiers. Scale up and tech transfer of products from R&D to commercial production, support of product launches.