Chunggeun Lee

Experienced Lead Scientist skilled in Biologics Drug Substance manufacturing, Technology Transfer, Scale-up, Facility fit, Process Validation and Continous Process Verification for various stages including clinical & commercial product.

Research experience for Cell Line Development / Purification / Analaysis focusing on engineering glycosylation of target protein.

Working as an upstream tech transfer SME,

• Successfully completed upstream technology transfer of ten (10) products.
• Authoring tens of manufacturing , technical and process validation documents; Process Control Strategy (PCS), Process Validation Master Plan (PVMP), Process Performance Qualification (PPQ) protocol, Facility fit study protocols and etc.
• Cross functional communication with relevant parties to come up with efficient and cGMP complying changes.
• Scientific and Statistical analysis to trouble shoot for unexpected manufacturing / process deviations.

Special experiences

• Large scale (3,000L) application of N-1 perfusion cell culture system. New product introduction from clinical to commercial manufacturing.
• White paper authoring; Large-Scale Continuous Biomanufacturing: Utilizing N-1 Technology For Higher Productivity And Quality (2022), Samsung Biologics.