Independent CMC Consultant in Technical Development and Technical Operations for Biologics and Advanced Therapies. Areas of expertise: • CMC Development and Process Validation, Tech Transfer and Operational start-up• Troubleshooting major manufacturing issues • CMC and Regulatory strategies • Evaluation, operationalization, and business development of new technologies • Due diligence evaluations (technology, products) for potential investors • Ad interim management / senior roles.Projects supported since Feb 2024:• Evaluation and troubleshooting of manufacturing issues (Advanced therapy);• Due diligence: supply and CMC evaluation for product licensing (Multiple projects - Biosimilars, Steriles, Biologics);• Preparation and programme design for process validation (advanced therapy);• Technology evaluation and further development for licensing/sale (Advanced therapy);• CDMO search and selection (Advanced therapy).

• 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 all batches, testing and associated activities on time and in full for numerous client and innovation projects in parallel;• 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.

• Manufacturing scale process development at new manufacturing site• Leadership of Process tech transfer activities (cell culture steps)• Active role in multiple cross-functional teams linked to site start-up (e.g., process mapping, materials management)

• Responsibility for a Neuroscience drug discovery and development team• Advanced on-going drug development projects and initiated new discovery projects

• Development of a novel genomics-based technology for drug candidate identification and optimisation• Initiation and formation of collaboration with an international multi-disciplinary project team