Halle, Flemish Region, Belgium
I hold a PhD and postdoctoral experience at USA, working in pharmaceutical development of bioactive molecules and engineering, respectively. As Scientist, I have a strong knowledge of GMP manufacturing, chemistry development from small (APIs) to large (peptides, proteins and monoclonal antibodies) biological and active molecules, scale-up, CMC, QbD, designing and executing experiments in laboratory and/or manufacturing scale. Additionally, I have a strong background in engineering working in MSAT departments, qualifying equipment's, installations, auditing suppliers and selecting new CMO's. As a Project Manager, I have successfully managed projects in different pharmaceutical companies in France and Belgium, overseeing all aspects from inception to completion. My ability to communicate effectively with stakeholders, manage project budgets, and resolve issues quickly has consistently resulted in the successful delivery of projects. I am highly skilled in various project management methodologies, including Agile, Waterfall, and Lean. My leadership style focuses on fostering collaboration and motivating teams, ensuring that each member is empowered to deliver their best work. Additionally, I have a deep understanding of risk management, stakeholder engagement, and quality control, which are critical to delivering projects successfully in dynamic environments.
Responsible for developing the manufacturing scale-up and control of medical devices pipeline. This includes raw materials control, formulation, scale-up from laboratory scale to pilot plant and analytical developments for R&D, pre-clinical and clinical batches.
Manage key company projects life cycle, including budget, risk management plan and commercial production.
Upstream and downstream specialist for DP manufacturing in sterile/aseptic filling lines (syringes and vials powders). Strong experience in lyophilization processes for solid powders. Responsible for planning and managing all aspects of the project budget, costs, quality, and timelines.
Responsible of decommissioning, technological transfer, VMP and process improvement at selected new CMO. Manager new DP development and geo-expansion. Ensured MDR compliance as per ISO 13485. People management of experts and technicians (15 people). Member of steering committee
Manage DP from technological transfer to harmonized QbD implementation. Led quality risk assessments and improved global CMC robustness. Lead and support project evaluations to create a new company portfolio: accountable for pharmaceutical projects in development, clinical phases 1 to 3 and commercial (budget ranging from 0.5M€ to +30M€).