Basel Metropolitan Area
“Opportunities multiply as they are seized” [Sun Tzu; 544 - 496 BC] Industrial Pharmacist with over two decades of experience in the bio/pharmaceutical value chain. Hands-on project manager accelerating and de-risking development assets via technical partnerships. Specialties: Manufacturing analysis and optimization, Project and change management, GMP/GCP regulatory compliance, Operational strategy consulting, Benchmarking, Outsourcing management. Business analyst with experience in strategic market research, business development and venture management. Specialties: Technology search, Opportunity evaluation, Business case assessment, Alliance development. Entrepreneurial personality: Curious, Diligent, Creative, Convincing. Excellent cross-functional matrix leader: International, Multilingual (en, de, fr, nl).
Enabling innovation use cases in technical development: 1) drug product manufacture at the site of clinical use; 2) individual made to order just-in-time supply of shortlived radiotracers; 3) point-of-care manufacture. Identifying, qualifying, contracting and managing the networks of CRO & CMO services to successfully deliver.
Leading outsourcing of drug product development for Roche/Genentech. (Small molecules / Biologics / Radiotracers). Managing assigned CMO's, technical transfers and external development projects.
CMC leader responsible for drug product development, clinical & commercial supply. Formulation development for NCE’s and supply of phase I, II & III studies with clinical trial materials (drugs / comparators / devices). CMO management for outsourced projects.
Strategic market research, business plan development and competitor profiling.