Lalit Saxena, Jihyun Lee, Gwangsik Kim and Soomin Yim

Lalit Saxena is a bioprocess engineer with more than 21 years of experience in the biologics process development, tech transfer, and GMP manufacturing (clinical/ commercial) of drug substance spanning monoclonal antibodies and complex biologics. He currently serves as a senior director of MSAT for technology transfer in clinical and commercial manufacturing at Samsung Biologics. He leads a team of bioprocess scientists dedicated to advancing DS manufacturing control strategies aligned with evolving biotherapeutics technologies. He plays an instrumental role in accelerating technology transfer, PPQ, and commercialization through the standardized implementation of process analytical tools as well as by applying statistical and modeling approaches to drive efficient innovation. He also serves as a member of the Parenteral Drug Association Biopharmaceutical Advisory Board (BioAB) and an author for multiple peer-reviewed publications.

Jihyun Lee serves as a director of MSAT, where she is responsible for drug substance scale-up/down technology transfer. With over 14 years of specialized experience, she provides strategic technical insights to ensure the seamless integration of tech transfer models and alignment of cross-functional activities. Her expertise encompasses process development, scalability, and risk-based facility fit assessments. Notably, she has demonstrated hands-on leadership in establishing integrated, standardized tech transfer platforms that optimize for manufacturing excellence.

Gwangsik Kim serves as an associate director of MSAT for upstream tech transfer at Samsung Biologics with 9+ years of expertise in cell culture. He hold a bachelor's degree in food bioscience and technology from Korea University.

As a senior scientist at Samsung Biologics responsible for upstream process transfer, Soomin Yim has been involved in more than 10 projects as both a subject matter expert and main project lead for over 8 years. With expertise in biotechnology, she advances successful tech transfer through comprehensive risk assessments and clear communication. She holds a bachelor’s degree in chemical engineering from the Georgia Institute of Technology.