Luan Nguyen
Associate Director, Manufacturing Science and Analytical Technology, Cell Therapies @Takeda
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WORK HISTORY
Associate Director, Manufacturing Science and Analytical Technology, Cell Therapies @Takeda
Cambridge, MA, US
Led cross-functional team for successful execution of four technology transfers of cell therapy processes to GMP sites• Led a high-performing team to successfully complete multiple comparability studies for critical material and manufacturing site changes, enabling smooth IND amendments• Drive late-stage manufacturing strategies in collaboration with Quality, Regulatory, and Analytical Development groups.• Oversee process optimization, lifecycle management, identify risk and mitigation strategy, deviation investigations, and process characterization.• Led major investigations (e.g. cell growth, transduction, aggregate, etc.), identified root causes, implemented CAPA and change controls• Authored and successful submitted IND and amendments, providing critical CMC contributions and ensuring regulatory compliance.
EDUCATION
Kyoto University
phD, Bioconjugation Chemistry, Microencapsulation, Islet transplantation, Immunotolerance
Universiti Sains Malaysia
Master, Material Engineering (Biopolymer)
Ho Chi Minh University of Technology (HCMUT)
Bachelor, Materials Engineering (polymer engineering)
ABOUT LUAN NGUYEN
Strategic and result-driven scientific leader with 14+ years of progressive experience across Process Development, MSAT, and GMP manufacturing supporting biologics and cell/gene therapies. Dedicated expert in technology transfer, CMC, process characterization, validation, PPQ, scale-up/scale-out, risk assessment (ICH Q9), aseptic processing, and lifecycle management. Proven expertise in directing complex technology transfers across global CDMOs and internal GMP facilities, with a strong CMC, GMP and regulatory foundation, supporting IND submissions and lifecycle management. Fostering collaboration and innovation through streamlined processes, data-driven decision-making, cross-functional alignment, and continuous improvement initiatives.
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