Ottignies-Louvain-la-Neuve, Walloon Region, Belgium
Current role:CMC Analytical Lead for commercial bioproducts (therapeutic monoclonal antibodies). Global role - leading analytical activities linked to initial BLA/MAA submissions and post-approval variations (EU, US, ROW). Accountable for analytical lifecycle management for bioproduct (DS, DP PFS and combination products). Coordination of activities to ensure submission and launch readiness of analytical package for product, plus strategic planning to ensure robustness of analytical package over product lifecycle. Responsible for planning of analytical budget (yearly + 10-year plan). Performing project management via Integrate (and Microsoft Project in previous roles). Responsible for analytical evaluation in due diligence exercises. Authoring and review of CMC analytical documentation including GMP quality elements (Deviations, Change controls, CAPAs). Troubleshooting support for analytical issues. Accountable for timely delivery of submission-quality protocols and reports for method fitness for purpose, method development, method validation, method transfer, stability, comparability, risk assessment. (In-process control methods, release & stability-type methods for monoclonal antibody). Previous roles: SME for physico-chemical and biological method development and validation, applied to bioproducts (cell therapy / ATMP, vaccines). Quality-focused. Team management experience. Prince2 Foundation Certified. Problem solver, troubleshooter, team player. Interests: Bioethics, Stress and burnout prevention, Regenerative Medicine
Mission at UCB Braine l'Alleud, Corporate Analytical Sciences (equivalent to Analytical Science and Technology department). Biologics: phase III -> commercial * Support to analytical development, analytical method validation, analytical aspects of process validation and transfer. * Project coordination with local internal facilities and worldwide CMO partner companies. * Lead design, authoring and coordination of stability studies on combination products (medical devices). * Lead delivery of analytical method documentation for combination products (medical devices). * Coordination of operational analytical activities. * Project Management using Integrate (Planisware). * Analytical SME review of method SOPs, method transfer and method validation documentation. * Analytical SME review of process transfer and validation documentation. * Author, reviewer and tracker of GMP quality items (change control requests, CAPA, deviations, ...). * Management of laboratory investigations and method troubleshooting.
- Project Manager, Team Manager, analytical method development, remediation and validation - cGMP Quality Manager and Writer (CAPA, deviation, change control) - cGMP Document Manager, Reviewer and Writer -Trained member of the QC 'Réseau de Vigilance contre le stress et le burn-out au travail'
Mission at GSK Biologicals - Management of QC Biochemistry - Validation of biochemical analytical methods (ELISA, HPLC, ...)
management of scientific projects, mainly bioassay development for mesenchymal stem cell-derived cell therapy products