Tessenderlo, Flemish Region, Belgium
Head of a manufacturing facility for production of recombinant therapeutic proteins, which is organized as an autonomous production unit (APU), i.e. a cross-functional team including manufacturing, quality, technical services… The facility is comprised of two suites for fed-batch processes with a total capacity of 9x 10 000L cell culture production bioreactors and associated downstream purification suites for drug substance manufacturing. One suite is equipped for ongoing commercial production of monoclonal antibodies (mAbs), the other for the planned introduction of a complex therapeutic fusion protein. Responsibilities include leading a cross-functional operational team of about 200 employees; compliance to internal and external safety, quality and regulatory standards for approved medicines by health authorities across the world (e.g. FDA and EMA), including associated audits; development and introduction of robust and efficient manufacturing processes; ensuring consistent product output at the highest quality standard; driving continuous improvement projects for increased productivity and plant capacity, cost efficiency and process robustness.
Leading the facility retrofit and introduction of a manufacturing process for a medicinal fusion protein into a running commercial manufacturing facility at Sanofi Geel. Responsibilities include leading a cross-functional project team of about 50 people and a Tier 1 engineering project to retrofit an existing suite (+120 M€ CapEx), including design, procurement and construction; technology transfer of drug substance manufacturing from external partner to Sanofi; setting up manufacturing operational readiness; new material introduction; quality readiness, including compliance, QC assay transfer and regulatory.
Head of the MSAT (Manufacturing Science and Technology) Purification team in Sanofi Geel (about 20 employees), which is part of the Global Sanofi MSAT organization and responsible for technology transfer, new product introduction, process validation, continuous process verification strategy, process control strategy, process life-cycle management, development of process improvements and second generation processes, complex product/process investigations, lab-scale studies related to issues, process robustness, initial process characterization, viral clearance validation, ... Support of manufacturing processes in Sanofi Geel, but also supporting transfer and development work in other sites in the Sanofi manufacturing network.
Post-doctoral research fellow in the Laboratory of Food Chemistry and Biochemistry (KU Leuven)