Taein Eom

Principal Scientist, Late-Stage Process Downstream Late-stage downstream process development, characterization, and validation studies.

Manager, Manufacturing Science and Technology • Designed the downstream process (DSP) laboratory layout and identified required equipment; authored URS and RFQs, and conducted technical bid evaluations to support procurement • Coordinated activities to ensure manufacturing readiness and prepared processes for technology transfer. • Directed hydrophilic linker platform development for antibody-drug conjugates (ADC) • Led yield improvement initiatives on client processes, identifying key improvement items and driving solutions.

Part Leader, Process Development Cross Funtional Team Leader, Rolvedon® Project • Led downstream process development for Rolvedon® (fc-fusion protein), from early design to commercial manufacturing. • Directed process characterization and validation studies, including resin/membrane lifetime, hold-time, and impurity clearance studies. • Authored key CMC documents (PCS, PMP, BLA Module 3.2 sections) and contributed to successful FDA BLA approval in 2022. •Acted as table host during FDA Pre-License Inspection, supporting regulatory discussions and inspections. • Led continued process verification (CPV) activities and investigations of deviations and out-of-specification (OOS) results to ensure process consistency and compliance. • Developed a second-generation API manufacturing process with a 5-fold yield increase.