CE Roy

• Transversal position : R&D, Quality Control, Quality Assurance, Digitalisation • Expertise: analytical chemistry, method transfer, regulatory strategy (CTD), QMS audits, global compliance (ICH, FDA readiness), project management • Management: multidisciplinary teams, OPEX/CAPEX budgets, Lean KPIs, and HSE engineering (lab renewal/creation). • Operations: strategic procurement, vendor management, OOS/CAPA investigations, and serving as a Scientific Liaison for CDMOs to drive end-to-end project success.

At Unither : • Coordination, engineering, and commissioning projects for major industrial stakeholders • Consultative approach and close client relationship management • Requirement gathering, needs analysis, and technical troubleshooting • Organizational change management

At Pierre Fabre • Analytical development, compliance, robustness, quality trail, marketing authorisation application dossier, CDMO, GMP, European Pharmacopoeia, USP

At Pierre Fabre: • R&D in Analytical and Industrialization at the Institute for the Developement of Active Ingredients • Projects involving extraction/synthesis/biosynthesis of active ingredients • Project management, CDMO follow-up, scope brief, project quote

Analytical Development, Compliance-Robustness, Dossier Q&A at the Pierre Fabre Institute of Research

Process introduction for USP TOC control in QC Laboratory

with Unither, ITEC, Phycher, Innothera Pharmaceutical drug and drug-delivery development Development and validation of analytical method in pharmaceutical and green chemistry Pharmaceutical service for major industries • Pharmaceutical / Chemical Development : synthesis, formulation, physical chemistry • Control : purification, characterization, identification • Quality : qualification, validation, lean, control • Frameworks : European Pharmacopoeia, ICH, SFSTP, GLP • Management : laboratories, security,

with GSK, AstraZeneca Pharmaceutical development and analyses of new catalysts Pharmaceutical drug and drug-delivery development Research and development for major pharmaceutical imdustries • Chemistry : strategy design, synthesis, catalysis • Control : purification, characterization, identification • Quality : validation, control • Frameworks : GLP, COSHH, HSE • IT : computer, network, molecular modeling • Management : laboratories, security, stocks, projects, teams • Mentoring : researchers and students

Sanofi, Evonik, CNRS, INRA Technical Expertise & R&D Organic Synthesis: Design and optimization of multi-step strategies (APIs, xenobiotics, therapeutic agents). Analysis & Control: Advanced purification, characterization, and structural identification. Specialized Testing: Physico-chemical and organoleptic analysis; biological assays. Regulatory & Quality Assurance Compliance: Strict adherence to GMP, GLP, COSHH-HSE, and Afssaps standards. Quality Control: Ensuring product conformity and process safety.