Consulting and Interim-Management for Biopharma and MedTech companies (since 2013)Recent 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 dossierPrevious Biopharma Projects with focus on FDA Remediation and Quality aspects:Process Validation for Upstream and Downstream Processing (USP/DSP), sterile Fill&Finish operations, Quality supporting processes, Data Integrity, Risk-/Gap-Analysis, CAPA management, Technology Transfer, Projects following Quality by Design (QbD), A-Mab-Case Study from CMC Biotech Working GroupMedTech Projects: Cardiopulmonary Devices (Heart-Lung-Machines), QC method development for single use components, Qualification and Validation activities, Root Cause InvestigationCancer Diagnostics: Validation of Manufacturing Processes (Mixing, Dilution, Thawing), P-FMEA, technical consulting with respect to selection of new equipment
Listed skills include Biotechnology, Biopharmaceuticals, Protein Chemistry, Validation, and 20 others.
