Bensheim, Hesse, Germany
Scientifically trained GMP and validation professional with interdisciplinary experience in pharmaceutical manufacturing, technical process understanding and industrial problem solving. Background in organic chemistry, material science and industrial product development with focus on translating complex scientific and technical challenges into practical, risk-based and sustainable solutions within regulated environments. Experienced in process and cleaning validation, GMP compliance, continued process verification, process optimization and cross-functional collaboration across manufacturing, quality, engineering and regulatory functions. Additional expertise includes ISO 50001 energy management, system-oriented process evaluation and data-driven approaches for continuous improvement in pharmaceutical operations.
• Establishment of energy-related processes, including energy planning and evaluation of energy projects • Cross-functional collaboration with Engineering, Production, Quality and Management for implementation of energy performance initiatives Milestones • Development and implementation of an ISO 50001-based energy management system within a pharmaceutical manufacturing environment
• Lead coordination and support of validation activities and projects within GMP-regulated manufacturing environments • Handling of GMP-/GCP-related activities, including manufacturing documentation updates, deviation assessment and process-related evaluations • Continuous optimization of GMP-relevant manufacturing and validation processes
Department FEC, R&D group of Dr. Heinz Stadtmüller, Medicinal Chemistry
• Responsible for process and cleaning validation activities for parenteral medicinal products and medical devices within GMP-regulated manufacturing environments • Validation and lifecycle management of manufacturing, cleaning, CIP and sterilization processes • Development and optimization of Continued Process Verification (CPV/OPV) and revalidation strategies using risk-based and statistical approaches • Execution and coordination of validation projects in close collaboration with QA, Production, QC, Engineering and Regulatory Affairs Milestones • Introduction of statistical process verification methodologies and data-driven validation concepts within manufacturing environments • Scientific and regulatory reassessment of registered process parameters leading to a significant reduction of unnecessary regulatory commitments • Initiation and execution of risk-based cleaning validation strategies enabling optimization of SIP frequencies while maintaining GMP-compliant process control • Conducted strategic screening and technical pre-evaluation of potential pharmaceutical product opportunities aligned with manufacturing capabilities, regulatory feasibility and portfolio diversification objectives
• Development of innovative film- and paper-based packaging solutions from laboratory to pilot and production scale • Responsibility for customer-driven development projects in technical and regulated environments • Development of sustainable packaging concepts using recyclable and biodegradable materials • Technical focus on polymer processing, blown film extrusion, coextrusion, printing and lamination technologies • Cross-functional collaboration with production, quality, sales, customers and suppliers Milestones None
Faculty of Organic Chemistry, Materials Chemistry • Research in the field of supramolecular and hydrogen-bonded liquid crystals with focus on structure–property relationships • Synthesis and characterization of functional organic soft materials using spectroscopic, thermal and crystallographic methods • Project responsibility within interdisciplinary scientific collaborations • Supervision and mentoring of students during laboratory courses, Bachelor and Master projects Milestones • Independent implementation of DFT-based computational approaches for structure-property investigations in supramolecular liquid crystals • Author and co-author of multiple peer-reviewed scientific publications in chemistry and materials science journals • Scientific collaboration with the Max Planck Institute for Polymer Research (Prof. Dr. Markus Mezger)
Faculty of Organic Chemistry, working group of Bringmann, Chemistry of Natural Products