rui han

QC Director in charge of the compendia and raw material team in cGMP manufacturing facility(CMO) 1. Developed raw material testing and sampling strategy in clinical and commercial phase in compliance with regulatory requirements for the domestic and international clients to meet their needs in filling IND and BLA in different country. 2.standarized compendialtesting precedure in compliance with multiple pharmacopiea 3. review and approval of SOPs ,methodl protocols, qualification protocols and reports 4.. Designed and developed the technical approach and testing methods for culture medium and resins. 5. Lead the OOS/OOT/atypical investigations related to raw material and compendial testing. 6. project sponsor in CMC team in support of IND and BLA filing. 7.Recruit, train, and retain a high performance team to ensure best quality services

QC /QA for reagents, instrument,and all real-time PCR based products lines and lot release. SOP writing/SOP modification •Quality Control(QC)/Quality Assurance (QA) for the instruments,reagents,used in QC and production of real-time PCR (q_PCR) based products in compliance of GMP and ISO standard. • Quality control and lot release of all real-time PCR based catalog and custom arrays including epigenetic analysis arrays, Epitect Methyl qPCR arrays, Epitect CHIP PCR arrays, RT2 profiler PCR arrays, miscript miRNA PCR arrays, and qBiomarker copy number arrays. a) setup q-PCR experiments, data analysis, lot release, QC report documentation. b) Trouble-shooting in designed experiment, problem-solving suggestion to the supervisors. c) validated the tech transfered from R&D,set up QC standard, SOP writing/modification.

Assay development in compliance of GLP standard.. Developed Antibody based platform of biotin-labeled protein microarray on different solid phase. • Developed and formulated buffer system based on the surface chemistry for the protein array platform,fixed background and S/N ratio problem • Designed / Optimized /Validated the protocol of protein array platform, maximized the system performance.

Method development under the guideline of GLP. • Developed /validated method for intact and functional mitochondria and other organelles extraction /purification by taking advantage of the PCT technology . • Developed automation methods for nucleic acids (DNA / RNA)/protein extraction and purification from biological tissues for research and forensic purpose by taking advantage of PCT technology • protocol/SOP writing and documentation. • prepared the data for Grant application

Research Fellow, with Dr. Terry Smith, Division of Molecular Medicine, Harbor-UCLA Medical Center Studied pathogenesis of autoimmune inflammatory eye disease called thyroid associated ophthalmopathy (TAO), focus on the mechanism of autoimmune initiated inflamation and tissue remodeling. research on inflammation reaction. • studied the cytokine profiling initiated by Tcell-fibroblast interaction(CD40-CD40 ligand) and pro-inflammatory cytokine IL-1, identified IL-1 is the key player in inflammation reaction and tissue remodeling in TAO • Identified and characterized the inflammatory prostaglandin E2 biosynthesis pathway of sPLA2-PGHS2--mPGES and house-keeping PGE2 biosynthesis pathway of cPLA@-PGHS-1-cPGES in orbital fibroblasts and dermal fibroblasts, and a different PGE2 biosynthesis pathway in thyroid cells. • Identified the signaling pathway of of ERK/1/2 and P38 and JAK2 in inflammatory prostaglandin E2 (PGE2) production, elucidated the mechanism of signaling ,pre- and post-transcription regulation ,and protein expression of the enzymes in inflammatory PGE2 production. • Studieded and elucidated the different effect of Th1 and Th2 cytokines on inflammatory PGE2 production . elucidated the pathogenesis of inflammation in TAO • Studied the induction, expression, regulation, and function of IL-1 receptor antagonist (IL-1ra) in modulation of inflammation reaction. studies on tissue remodeling • Studied inflammatory cytokines IL-1 induced expression, and regulation of collagens, metalloproteinase/tissue inhibitor of Metalloproteinase (TIMP), and hyaluronate in orbital fibroblasts. •studied the regulatory effect of the other TH1 and Th2 cytokines on IL-1 induced Tissue remodeling.in orbital fibroblasts. • elucidated the mechanism of tissue remodeling process in different stage of TAO

Research Associate, with Dr. Terry Smith, Division of Molecular Medicine Studied biosynthesis of collagen and collagenase in orbital fibroblasts and role of interleukin-1 receptor antagonist (IL-1ra) in modulating inflammation reaction.

with Dr. Leslie Louise in Molecular Genetic lab. Studied the mechanism of antibiotic-resistance bacteria, focus on the mechanism of transposon of insertion sequence 2 (IS2) in E. Coli • cloning IS2 elements into plasmid and phage ,transformation the constructs into E.Coli;screening and harvest the plasmid/phage;sequenceing. • analysis the sequencing data,

Management;Teaching; Clinical research •Management the budget,instruments,personnel of the Clinical Immunology Lab and the Department. • Teaching/mentoring the student intern of Laboratory Medicine major •handling the complaints from patients ,inter-Department and the other department in the Hospital • coordinated and participated in the clinical trial and research projects in the cancer immune therapy (LAK ) ,and transplantation clinical research. • supervised the rutine work of Clinical Immunology Lab, developed and apply new methods for clinical diagnostic purpose. • Established and setup the Clinical Molecular Biology Diagnostic Lab, Developed the diagnostic methods based on the PCR technique for TB, HBV,and pathogens for STDs.