Yann WAHL

•Project Portfolio Management : -Collect Tech Ops project proposal and insure adequate information is provided (Financial, benefits, risks) -Prioritize according benefit vs effort criteria and set retained projects for further evaluation-implementation •Lead projects in the recombinant network according to defined matrix – process manufacturing related •Lead the overall design of the process changes and monitor the execution •Report out progress to senior management within the Project Review Committee

•Preparation and follow-up of sampling protocols in collaboration with analytical laboratories and production team. Inter-site Management •Modeling on Super Pro Designer, of the production process to assess areas for improvement and perform simulations for implementation of new technologies. •Establishment of a validation strategy for the submission of a new product. •Weekly preparation of SPC to monitor process parameters and investigate the special root causes behind deviations.

•Review of FMEA parameters and criticality reassessment following investigations and new elements of knowledge. •Establishment of a " gap remediation plan" to document and formalize all solutions. •Changing interlocks in collaboration with the production staff to reduce waiting time (Hold time) of the product in the operational flow and improve its quality (including viral aspects). •Collaboration with the laboratory at pilot scale to conduct studies on the product and obtain new pieces of knowledge.

• Drafting protocols. Planning, performing validation tests on process and equipment’s • Writing of the validation reports. • Implementation of sampling and work plans in collaboration with internal departments. • Defining requirements and drafting URS for new equipment purchasing. • Validation of plans,PID’s and Isometrics • Review of functional nomenclatures of a new formulation zone. • Implementation of a stock of critical spare parts to ensure continuity of the production operations.

Design, dimensioning and implementation of a crystallization process applying supercritical anti-solvent on an active pharmaceutical substance: • Literature search on the solubility of the solvent, anti-solvent and the active substance. • Determination of the thermodynamic model to apply to the simulation (Aspen Plus). • Process modelling on Aspen Plus and establishment of process parameters according to maximum performance and environmental standards. • Evaluation of costs and ROI

Process Engineering, Production and Supply Management, Project Management, Flow simulation, Processes Modelling, Continuous improvement (Lean, 5S, VSM).

Microbiology, Analytical Chemistry, Process/Food Engineering, Quality