Francois Pfaff

• French and English spoken position; local and international projects; subcontractants coordination • Project management: formulation step, scale-up, development & clinico-regulatory batches, packaging, stability studies and industrial transfer / validation • Coordination / work in collaboration with the different development dept (technicians, analytical devpt, QA, RA...) to the transfer / validation (production, QC, system & operational QA, supply, methods ...) • Presentation of progress/milestones to the Steering Committee • Evaluation of the resources needs: people, equipments and budgets • Redaction of the associated documentation: development / validation plan, protocols, reports, technical parts of the MA file ("Quality by Design" type) • Change management, especially through risk analysis • Theoretical and practical evaluations of processes as part of continuous improvement processes • Liquid forms: nano-milling, oro-dispersible films; solid forms: multi-particulate forms, fluidized air bed, wet granulation with high shear granulator, dry granulation, compression

• International projects, English and French spoken position • Change management at the interface between the global project team and the operational team • Change management at the interface between the global project team and the operational team • Implementation of a second source of active ingredient via product / process risks mapping and tests in pilot laboratory as well as in production • Inter-sites products transfers • Recommendations redaction in the frame of risk management • Solid (tablets, sachets, capsules) and liquids (dry syrups) dose forms

• Coordination of steps of formulation and of industrial transposition, semi-solid forms • Coordination, constitution et finalization of 2 MA files

• Formulation life cycle and process selection of a solid dose form; laboratory and pilot scales • Prototypes analyzes by HPLC

• Implementation of a design of experiments plan for a formulation optimization of oro-dispersible tablets