Dynamic professional with extensive experience in product technical support and project management. Proven ability to manage product issues and troubleshooting, and enhance product features and documentation, contributing to improved operational efficiency and customer satisfaction.
● Supported library prep activities for nanopore sequencer
● Supported high throughput single cell protein and RNA sequencing assay and contributed to a paper publication
● One of the major contributors to the T-cell receptor sequencing assay development
● Led the immune-sequencing assay transfer to other groups and collaborators, including San Jose CLIA lab, CRO company, and UK research institute for assay feasibility assessment
● Provided technical trainings and timely support
Participated in AVENIO Tumor Tissue Analysis assay development; planned
and executed sequencing experiments for TPV performance study
● Provided troubleshooting on issues that arise related to assay performance
● Key contributors in HCV drug resistance SMRT sequencing assay
development; led the primer design and screening for the remarkable
heterogeneous HCV virus
● Participated in RNA extraction method evaluation, and RT-PCR optimization;
improve the amplicon yield significantly to achieve LOD requirement
● Collaborated with bioinformatics group and facilitated pipeline
development with synthetic HCV variants model
● Provided sound and detailed presentation in technology review meeting,
regular cross team group meetings
● Supported screening new primers and probes with synthetic HCV RNA transcript to optimize its inclusivity and specificity for HCV Genotyping assay
● Constructed phage lambda armored HBV DNA used as positive control for Cobas® HBV DNA test
Research & Process Development
Responsible for several key reagents MFG process development, IQC and QC, scale-up, validation and implementation for the point-of-care CD4 T cell enumeration HIV test
● Improved streptavidin polymerization reaction yield and binding capacity
● Optimized protein purification process with custom assembled tangential flow filtration system
● Designed and executed native and biotinylated antibodies stability study
GMP Manufacturing and Quality Compliance
Served as a liaison between PD, MFG, QC and QA groups ensuring timely reagents delivery and quality compliance
● Led the production and quality control testing of polymerized streptavidin
● Validated the scaled-up streptavidin polymerization and purification process
● Authored and executed the IOQ and method validation for tangential flow filtration system and Biacore 3000
● Led the validation for excels spreadsheet templates used in many reagents quality control testing.
● Experienced with deviation and NCR report writing, pFMEA estimation-
● Transferred co-polymer synthesis manufacturing process to MFG group
● Trained two technicians on reagent manufacturing processes
● Provided direct support to materials department for COGS, BOM, materials forecasting, and its transitioning to ERP system
Particpated in developing and manufacturing HPV Quantivirus kits and Cytokine assay kits