Écaussinnes, Walloon Region, Belgium
Mechanical engineer by education, I have 15 years of experience in the biotech industry on the development of disposable bioreactors and process controllers (hardware and software) for cell therapy, vaccines and gene therapy applications. Areas of expertise: - New product development - Project management - Industrialization of new product - Validation/Qualification
Lead of R&D team, 9 engineers - Design and development of disposable bioreactors and related cell culture process controllers (hardware and software) for Vaccines and Gene Therapy applications - Process controller conformity: CE marking, CE conformity assessment, UL certification - Continuous improvement of disposable devices and related process controllers - Technical support to manufacturing team - Creation of process controller documentation (URS/FDS/HDS/SDS/FAT/SAT/IQ/OQ) - Close collaboration with cell culture development team - Transfer of ownership of technical support to field service team - Transfer of ownership of procurement, test and release of process controllers to Pall hardware manufacturing group in UK - Support to Sales and Marketing - Team development, recruitment of employees and consultants
Lead of Product Development team, 2 engineers and 1 technician - Design and development of disposable bioreactors - Establish low volume production line - Test and validation of product performances and quality - Transfer production to manufacturing team for large volume - Validation of manufacturing processes through IQ/OQ/PQ - Continuous design and process improvements - Technical support to Sales and Marketing - Use and promote six-sigma methodology
Design of disposable bioreactor and cell culture process for cell therapy application - Manage cross-functional team (engineering, supply chain, QA, cell culture lab) - Improvement and scale-up of customer cell culture process - Lead customer relationship - Define product specifications - Build and test prototypes - Develop bioreactor manufacturing process and select subcontractors