Ghent, Flemish Region, Belgium
Leading a team of Project Engineers responsible for clinical manufacture of novel pharmaceuticals in the pilot plant. Focus on biological (mAb's, proteins,...), parenteral compounds for Oncological and Inflammatory use. Translating the needs of R&D into a production environment.
Project Lead of a multidisciplinary team for the implementation of a novel anti-viral pharmaceutical in the commercial plant. The project was executed at "Lightspeed" due to global interest. Responsible for coordination of the Core Team, supporting the Launch Team and budgetcontrol.
Project lead of a multidisciplinary team for the introduction of a new parenteral monoclonal antibody for commercial production. I bridge between R&D and the production department. The main tasks are coordination of the equipment-adjustments, defining critical quality attributes and critical process parameters, performing process qualification and validation, and writing the registration files for different authorities. Furthermore as a product specialist, I provide technical scientific guidance for the product and its manufacturing process through the combined challenges of supply, quality/compliance and cost.
Project engineer consultant in the life sciences industry. Projects: - Project Lead Launch Excellence - Pfizer - Project Engineer Product Support - Pfizer - Cleaning validation Engineer - Clinical Supply Unit, Janssen Pharmaceutica - Process and cleaning validation Engineer - Commercial Supply Unit, Janssen Pharmaceutica
- Cleaning validation for pharmaceutical manufacturing plant at Beerse site - Single Point of Contact for everything related to cleaning for the liquid and sterile departments. - Project lead for the implementation of a cleaning (validation) strategy of a continuous manufacturing line for solids production. - Support for new product introductions - Front Office Audit support for Cleaning Validation topics - Event / Change control / CAPA
Lived and worked in Brisbane + travelled all across Australia
- Project engineer for both process and cleaning validation - Validation of product manufacturing and cleaning processes - Improvement of existing manufacturing and cleaning processes - Impact assessment and deviation handling - Event / Change control / CAPA