Basel Metropolitan Area
Senior Leader in Technical Development and Technical Operations for Biologics and Advanced Therapies. With nearly 25 years of experience (15 years in leadership roles) in developing and commercialising biologics and advanced therapies, I have successfully built teams, processes, and systems that enable on time, at quality, and agile biopharmaceutical development and operations. Previously overseen the CMC development of multiple biologic CTD/BLA submissions, with extensive experience in outsourced development and manufacturing, having both worked for, and been a client of, CDMOs.
• Leadership of all technical development and technical operations activities for Beacon's portfolio of ophthalmologic AAV gene therapies (one late stage, one early stage product) • Budget management • E2E owner of supply chain, and management of a network of supply partners • Management of team of TechOps/Dev Functional Leads • Member of company Executive Lead Team, reporting to CEO • Quarterly in person updates/progress reports on CMC and Supply chain function to Board of Directors
Consulting support in Technical Development / Operations for Biologics and Advanced Therapies, from clinical phase through validation, launch and commercial supply, and due diligence advice. Working in different modes to support client needs: • Lead specific initiatives or fill strategic or operational roles ad interim • Functional role as team member or task/output focus • Grow and develop team and/or organisational capability • Evaluation, due diligence, advice, support Working individually, or as part of teams with consulting houses, depending on needs. Areas of expertise: • Due diligence evaluations (technology, products, suppliers) for investment decisions • CMC Development and Process Validation, Tech Transfer and Operational start-up • Troubleshooting major manufacturing issues • CMC and Regulatory strategies (biologics, steriles, gene therapies) • Evaluation, operationalization, and business development of new technologies • Strategic and organizational evaluation and support Multiple projects supported and successfully delivered since Feb 2024.
• Leadership of site Technical Development Unit (~team of 45; scope included Analytical and Process development, transfers and validation, Virology SME, CMC strategy and programme design); member of company Executive Committee (ExCom); • Delivered DS/DP batches, testing and associated activities on time and in full for numerous client and innovation projects in parallel for rAAV and rLVV projects; • Implemented operation and resource management tools and approaches, reorganised teams (optimisation, budget challenges); • Business Development: led/supported proposal writing (competitive selection processes) and client discussions; directly responsible for numerous contract wins; SME support at global conferences; Led Q&A sessions, audits with clients.
• Leadership of site MS&T Unit (team of ~50; scope included Process Development labs, Product and Biosafety Stewardship, Tech Transfer and Process Validation); member of manufacturing site leadership team (SLT); • Ensure production support, process optimisation, and continued validated state for four commercial products (~130 DS batches / 300mUSD COGS p.a.); • Established data-driven yield improvement initiatives leading to ~12% gains in final batch yields; • Oversight of a complex manufacturing process improvement programme for multiple products (>100 markets, regulatory relevant changes), with alignment across manufacturing sites.
• Overall Global CMC Lead for one biologics product (all manufacturing activities [DS, DP]); member of Global Brand Team; organised and led all CMC submission activities for on-time (met stretch target) product launch in China, including full regulatory dossier remediation (old dossier). Support/CMC Lead for follow-on regulatory submissions on LATAM, India, Australia; • Global CMC Lead for all drug substance programme activities for second biologics product (on-time first global CTD submission, Health Authority interactions; DS site lead for FDA PAI preparation (no 483); • Global Lead for network scaling / expansion: parallel DS process transfers to new manufacturing sites (EU, Asia); transfer organisation and planning, budget definition (CapEx, OpEx), approval and management; team and stakeholder management, resourcing; • Led resolution of major manufacturing issues (global supply impact, high political visibility) and DS/DP life cycle management initiatives (e.g., DP PFS shelf-life extension enabling additional country approvals).
• Leadership of process tech transfer for first biologics drug substance manufacturing process to site (fully single-use process, co-developed with alliance partner); • Design and implemented an approach for integrated process control strategies subsequently used for all biologics products within network; • Managed Tech Transfer team, maintained ongoing communications with stakeholders and senior management; • Co-led Late Stage process development (involving 15+ scientists across two locations); • Execution of manufacturing for clinical batches, development of GMP manufacturing systems.