Hui-I Tom

WORK HISTORY

EDUCATION

SKILLS

ABOUT HUI-I TOM

Oversee and lead a group of scientists and managers for method development, method qualification, method validation, robustness, method optimization, method transfer, investigation, change control, and non-conformance event projects in GLP and GMP environments. Specialized in cell-based potency assay, plate-based potency assay, HCP ELISA method, cell-based neutralizing antibody method, HPLC, binding ELISA, residual ELISA, and residual DNA by qPCR for large molecules and biologics development. Equipped with extensive background in protein biochemistry, nucleic acid biochemistry, and mechanistic protein/DNA metabolic pathways. Possess excellent teamwork, communication skills, computer expertise, and ability to interpret wide-variety of data​: write SOPs/protocols/reports/research grants/peer-reviewed research publications, compile complex data, make poster/slide presentation, draft/verify sections of BLA and analytical control strategy (ACS) documents. Conduct document/assay reviews and data verification. Employ good time management, prioritized project management skills, high work ethics, and efficiency. Hold extensive knowledge and experience in method development/optimization, compliance, protein biochemistry, nucleic acid chemistry, DNA/RNA enzymology, antibody engineering, cancer biology/oncology. Serve as CMC analytical leads and understand drug and method developments. Lead process improvement initiatives and make strategic decisions.