VP, Manufacturing Science and Technology (MS&T)

Tim Largen

Tim has over 20 years of experience in CGMP manufacturing, process engineering, and CMC development experience in clinical and commercial operations in cell therapies and other complex and time-sensitive biopharmaceuticals. He has extensive experience with technology transfer, manufacturing start-up and scale-up, quality systems, and a successful track record of FDA and other regulatory inspections and responses.

Prior to his role at Lykan Bioscience, Tim held leadership roles in Technology Transfer, Technical Services, Process Engineering, and Quality Assurance at Dendreon over an 8 year-tenure. He was responsible for ensuring technical issues were promptly investigated, evaluated, and resolved to support cell therapy disposition. He had identified and led the implementation and validation of many process improvements in manufacturing, continuously improving production success rates and product quality and consistency, resulting in millions of dollars in cost savings. Tim drove the implementation of a detailed process description based on Quality-by-Design principles and historical process development and validation studies, which standardized disposition decisions for highly time-sensitive autologous cell therapies delivered to over 25,000 cancer patients.

Additionally, Tim has worked for several clinical and commercial stage cell therapy and radiopharmaceutical companies, where he held leadership and hands-on roles in manufacturing and quality system start-up, process validation, CMC development, and internal and contract manufacturing management and has hosted or served as a key contributor to multiple FDA surveillance and successful pre-approval inspections.

Tim received his BS in Biology with honors and his MBA in Operations Management Science.

What inspires Tim is solving manufacturing and technical challenges to bring innovative and life-saving products to patients, reliably, efficiently, and safely. He is thrilled to work at the intersection of Science, Engineering, Operations, and Quality to help develop new therapies and continuously improve processes for market readiness and beyond.