George Bu

Background

About George Bu

Accomplished R&D leader with a diverse background and extensive experience in the Pharmaceutical (Johnson & Johnson), CRO (Frontage lab), Biotechnology/CDMO (Thermo Fisher Scientific) companies. Proven track record of success in drug discovery and development. Demonstrated abilities in leading productive R&D teams and managing cross-functional projects in multi-disciplinary setting. Accomplishments in Drug Discovery and Development: • Contributed to the discovery of samidorphan, a drug approved by FDA in 2021 for use in combination with olanzapine as a monotherapy (brand name: Lybalvi) for adults with schizophrenia and bipolar I disorder. • Provided analytical development of Invokana™ (Canagliflozin), the first-in-its-class type 2 diabetes drug approved by FDA in 2013. • Provided analytical development for CMC regulatory submission of VALCHLOR™, a drug approved in 2013 as the first FDA-approved topical formulation for the treatment of early stage skin cancer. Key strengths: • Analytical, Organic and Biochemistry • GMP Regulations and CMC Activities • Pharmaceutical Analytical Development • Method Development and Validation • API and Drug Product Characterization • FDA Regulations and ICH Guidelines • Regulatory Submissions • Cell Culture Media Development • BioAnalytical and Molecular Biology Techniques • Small Molecule Analysis • Large Molecule Characterization • People and Project Management • Technology Integration and Transfer Technical skills: • HPLC/UPLC, HPLC/UPLC-MS, GC, GC-MS, ICP-MS, CE, NMR, IR/NIR/Raman, UV, KF, XRF, TGA, DSC. • Extensive experience with LC-MS: Thermo Orbitrap, Waters Acquity TQD, AB QTRAP, Agilent Q-TOF. • HPLC/HPLC-MS softwares: Empower, ChemStation/MassHunter, Xcalibur, Masslynx, Analyst, Drylab. • HPLC method development, validation, implementation, experimental design and problem solving. • Drug substance and drug product characterization, GMP release and stability assessment. • Structural elucidation of process impurities and drug degradation products by HPLC-MS/MS. • GMP regulations, ICH guidelines and Standard Operating Procedures (SOPs) in drug development. • Technology integration, method transfer, data review and documentation, regulatory submission. • Small molecule analysis of cell culture media or biological matrix by UPLC, UPLC-MS, GC-MS, IC, ICP-MS. • Large molecule characterization by LC (reverse phase, Hilic, ion exchange, size exclusion, affinity), LC-MS. • Gene subcloning, cell culture, protein expression and purification, qPCR, SDS-PAGE, ELISA, CE, cIEF, etc.