Zhihai Si
Director of Quality Control @Ultragenyx
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WORK HISTORY
Director of Quality Control @Ultragenyx
Woburn, MA, US
EDUCATION
University of Iowa College of Medicine
Ph.D., Microbiology, Virology
SKILLS
ABOUT ZHIHAI SI
Expertise in assay development/qualification/validation in the gene and cell therapy space. Hands-on experience with the development of biochemical /enzymatic assays, cell-based assays, molecular biology assays, immunoassays, and virus-based assays under QC/AD environment. 12 years of industry experiences in biopharmaceutical companies and 10+ years of academic research experience. Highly experienced in QC functions in mammalian cell bank, virus bank, plasmid, and AAV-based drug product manufacturing. Expertise in test method qualification/ validation, internal/ external test result reviewing, specification establishment and revision, certificate of analysis preparation and product lot release. Established and managed specifications and stability programs. Prepared budgets for product release test, stability and virology lab. Acted as QC representative in CMC team. Participated in regulatory activities for pre-IND, IND and late stage clinical trials, and NDA. Strong managerial and inter-personal skills; exceptional leadership in project management and team building. Molecular biology skills: qPCR/ siRNA/ DNA manipulation/ cDNA library/ plasmid/ restriction enzyme digestion and cloning /in vitro transcription/RNA manipulation/gel electrophoresis/mRNA expression by RT-qPCR.Cell biology skills: Primary human and mammalian cell culture/ stem cells/cell line culture/3-D cell culture/cell-based assays/ transfection and transduction/histology/ fluorescence microscopy.Immunology skills: ELISA/MSD/Immunoassays/ flow cytometry/ PBMC isolation, T cell, B cell, and immune cell manipulation/hybridoma culture/monoclonal antibody purification and labeling/Western blot.Virology skills: AAV TCID50 assay/ residual infectious Adenovirus 5 assay/ replication-competent AAV vector detection assay/Adenovirus vector transduction/ lentiviral and retroviral vector construction and transduction/ genome copy-based quantitation for influenza virus, hepatitis C virus, and HIV/retrovirus.Biochemical /enzymatic assays: Protein and enzyme expression and purification/ SDS-PAGE/assay development and optimization /size exclusion, ion exchange, and affinity chromatography.Project management skills: Project management with CROs/CMOs/CTLs to meet timeline/internal project lead/cross functional team work.
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