Ceo
CurrentCONSULTING and INTERIM-MANAGEMENT for BIOPHARMA and MEDTECH:COVID-19 VACCINE PROJECT:• Tech Transfer Lead for sterile Fill & Finish operations with Key Accountability (FPOC) for CMO • Cross functional multinational Project Management within large teams• Close collaborations with big European pharma companies • Tech Transfer documentation, Risk analysis, identification of gaps, scientific studies, Root Cause Investigation (RCI), Process Performance Qualification (PPQ), Comparability Planning, Change Management, Equipment Qualification, Transport study (-80 °C cold supply chain)• Support for Analytical Method Transfer, Quality Agreement, Release Process, Labelling and Packaging activities• Support for Regulatory Affairs: Data and information collection, preparation of packages for dossier• GMP Compliance for DS productionPrevious BIOPHARMA PROJECTS with focus on QUALITY ASPECTS, FDA REMEDIATION:• CELL CULTURE UPSTREAM & DOWNSTREAM PROCESSING following Quality by Design (QbD), A-Mab-Case Study from CMC Biotech Working Group• MONOCLONAL ANTIBODIES – Manufacturing Science and Technology (MS&T): Validation for USP, DSP, Cleaning, Risk Assessments• STERILE FILL & FINISH OPERATIONS - Multi-factory/site FDA Data Integrity project: Risk-Assessment, GAP-Analysis, CAPA Management, Quality supporting processesMEDICAL TECHNOLOGY PROJECTS:• CANCER DIAGNOSTICS – HERCEP TEST: IMPROVEMENT and VALIDATION OF PRODUCTION PROCESSES (Mixing, Dilution, Filtration)• CARDIOVASCULAR DEVICES / HEART-LUNG-MACHINES - QUALITY CONTROL for Oxygenators, Arterial Filters, Cardioplegic Devices, Centrifugal Pumps, Catheders: Development and implementation of NEW TEST METHOD FOR MICROPARTICULATE CONTAMINATION according to requirements of UNITED STATES PHARMACOPEIA and INTERNATIONAL STANDARDS SELECTED CUSTOMERS: Novartis Pharma (Basel), Boehringer-Ingelheim (Ulm area), AbbVie (Ludwigshafen), Dako-Agilent (Copenhagen), Getinge Group: Maquet Cardiopulmonary (Stuttgart area)
