Douglas Smith

Mr. Smith has over 35 years of biologics and cell therapy development, validation, and commercialization experience, including foundational career tenure at Amgen. Since transitioning into senior advisory roles, he has guided numerous small biotech and startup companies through the critical evolution from clinical-stage operations to full system maturity. A Chemical Engineer by training, Mr. Smith brings a rigorous, data-driven approach to CMC strategy, technology transfer, and process optimization, holding professional certifications in Lean Six Sigma, GMP Auditing, and Artificial Intelligence. He specializes in bridging foundational engineering principles with modern advancements in eQMS digital transformation to implement fit-for-purpose infrastructure that ensures data integrity and operational readiness. His hands-on expertise spans the entire product lifecycle for MABs and advanced Cell Therapies (CAR-T), from Master Cell Bank (MCB) establishment through Process Performance Qualification (PPQ) runs, Fill/Finish operations, and global Shipping Qualification. As a specialist, he has presided over the successful validation and tech transfer of numerous products while authoring CMC sections for global regulatory submissions. He holds a Bachelor of Science in Chemical Engineering from the University of Iowa.