Description
Summary Research scientist with an excellent track record of productivity in R&D and regulatory (GLP/GMP) industry R&D experience (immuno-oncology) * Contributed to project completion for FDA IND filing by creating 8-10 stable antigen presenting cell lines, and 3 target lines to expand and test chimeric antigen receptor-modified T cells. * Optimized/Validated cell-based assays (proliferation, cytotoxicity, cytokine production), and tissue culture conditions (growth, expansion, cryopreservation) leading to process or downstream assay improvement. * Expertise in handling cell lines and primary cells: single-cell cloning, PBMC isolation, cell enrichment/depletion. Experience with human biological samples and infectious agents (BSL2/3 lab). * Expertise in flow cytometry (FACS) to analyze target or receptor expression, activation, proliferation or cytotoxicity, and assays such as SDS-PAGE, ELISA, DNA/RNA isolation and analysis, qPCR, gene cloning, siRNA/shRNA. * Proficiency with data acquisition and analysis softwares: FACSDiva, FlowJo, LIMS, SDS, SoftMax, GraphPad, Geneious. Participated in Electronic Lab Notebook to improve lab recordkeeping and regulatory compliance. Regulatory (GLP/GMP) * Achieved >95% on-time, accurate data delivery in performing GLP/GMP assays. Increased revenue by 45% and testing efficiency by 15% by validating new 2 qPCR assays * Excellent leadership and staff management: Trained 5 new lab operators (rate of <5% error in performing GLP/GMP assays). Managed team of 8-10 lab operators (BioReliance), 2 lab technicians and 3 students (UCI and NIH). * Acted as Subject Matter Expert (SME): 1) Authored multiple (8-10) SOPs, 2) Resolved protocol deviations, 3) Effectively liaised with clients to resolve data issues, 4) Created crucial databases (primers, probes, standards) to ensure testing compliance. * Detail-oriented, excellent time management and effective communication skills to complete simultaneous projects in cross-functional teams
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