Eric Ka-Wai Hui
R & d Manager @Thermo Fisher Scientific
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WORK HISTORY
R & d Manager @Thermo Fisher Scientific
Lead the Cell Group in the development, production, optimization & improvement of IVD products for human leukocyte antigen (HLA) antibody detection.1. People leadership & performance management: • Lead and mentor up to 11 scientists, ensuring all activities adherence to 4i policy and operational excellence frameworks PPI & 5S.• Drive talent development through PMD approach, including goal setting, mid-year & year-end evaluations.2. R&D management:• Oversee research studies supporting new products development & enhancement of existing IVD products. • Participate in DOE & edit SOP. • Lead initiatives to optimize the media for culturing cell lines to enhance product performance.• Advance HLA biology research, including bioreactor scale-up/scale-down, B cell, T cell & hybrid platforms, memory B cells isolation, HLA epitope/eplet mapping, immunopeptidomic profiling.3. Manufacturing & PD tasks management:• Lead new cell line development & characterization.• Lead cell culture scale-up using WAVE 25 bioreactors and oversee PV and tech transfer for NPIs. • Author and release internal documents for product processing to Manufacturing.• Collaborate with GMP manufacturing to implement improvement and CAPA plans. • Review Validation Plans, Validation Reports & NC Reports. • Directed cross-functional efforts with R&D Cell Group & Manufacturing teams to generate 36 new cell lines within 1.5 years to improve product reliability and market performance.4. Cross-department functional collaboration: • Work with Manufacturing, QC & RA teams to ensure PV for culture scale-up plan using WAVE 25 bioreactor.5. COVID-19 response leadership:• Directed a cross-functional COVID-19 task force to produce >500 mg/year of recombinant coronavirus SARS-CoV-2 spike (S) glycoproteins for supporting development across Thermo Fisher Scientific sites.6. Scientific communication:• Deliver presentations on research progress & advances in cell biology & immunology.
EDUCATION
National Yang Ming University
Doctor of Philosophy (Ph.D.), Microbiology and Immunology
Fu Jen Catholic University
Bachelor of Science (B.Sc.), Biology
Fu Jen Catholic University
Master of Science (M.Sc.), Biology
ABOUT ERIC KA-WAI HUI
More than 14 years of cell line development, process development (PD), upstream processing (USP), downstream processing (DSP), tech transfer, validation, and manufacturing support experience. Team leading and management experience in Fortune 500 company and startup company.
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