Lausanne Metropolitan Area
With a core downstream manufacturing process expertise and 10+ years of industrial experience, I led CMC programs for monoclonal antibodies, Fc-fusion molecules, vaccine conjugates, and gene therapy programs from development through Phase I–III clinical supply, and including GMP manufacturing of APIs and drug products. ## Industrial competences ## ____________________ - USP & DSP process development; DP manufacturing - GxP documentation (change controls, deviations, CAPAs) - CDMO selection, contracting, and technical oversight - End-to-end CMC program leadership; Clinical supply strategy and execution - Regulatory documentation and IND/IMPD submissions At AC Immune, I led the CMC activities across multiple biologics programs including a Phase 2 vaccine conjugate, monoclonal antibodies, and through initiation of a gene therapy program. I previously held DSP SME roles at Lonza and UCB, supporting late-stage development, GMP tech transfers, and global quality investigations and improvement programs. Scientifically grounded (PhD in Medicinal Chemistry, Structural Biology background), my focus is always to deliver robust, phase-appropriate processes that enable regulatory success and reliable clinical supply. I bring strategic CMC leadership, operational execution, and rigorous science to deliver innovative and qualitative biologics into the clinic, with a strong drive for continuous improvement. Didier [email protected]
• CMC Project Lead: Coordination of activities for AC Immune biological drugs, including a vaccine conjugate in phase 2, Monoclonal antibodies from development to phase 1; Initiation of a gene therapy program, IMPD & IND submission and clinical supply • DS, DP Process Lead: CDMO contracting and technical oversight of processes development, GMP production, including technical transfer & scale-ups for clinical stage supply. Quality documentation and preparation of regulatory submissions.
• CMC project lead: Coordination of activities for multiple biological drugs, including a conjugate vaccine in clinical phase 2, and monoclonal antibodies from development to clinical phase 1; IMPD & IND submission and clinical supply; Initiation of a gene therapy program. • Function Lead for USP, DSP and formulation activities (CDMO management): Pre-clinical and clinical development, technical transfer & GMP production (Drug Substances and Drug Products) and product quality management.
• Customer facing role in charge of DSP process development of antibody-derived molecules • Tech transfer to pilot scale, GMP batch • SME role as part of global quality investigations team • Innovation: expansion of high-throughput screening capabilities; new low endotoxin material supply strategy
As a lead scientist in the purification development department at Lonza Biologics I directed the development of mAb and non-mAb manufacturing purification processes for up to 20,000L and support customers through progress meetings, from project initiation, process design and troubleshooting, including process transfer. I also actively engage in operation excellent projects aimed at expanding the department capabilities (High throughput screening, low endotoxin offering, non-mAbs DSP screening platform).
• Scale-up of antibody production towards Phase III clinical studies and IMPD/IND submission • Process characterisation and FMEA • High-throughput screening (Tecan), DoE and scaled down model qualification • Continuous DSP manufacturing
DSP Preparation for Phase III clinical studies for a monoclonal antibody: • Downstream process development with high-throughput screening (Tecan) & DoE • Scaled down models validation, process characterisation, FMEA, and IMPD/IND submission