James Yi Email & Phone Number

Bothell, Washington, United States

• Tech Transfer Team:
• Perform sample testing for stability and release testing, then analyze/compile data with reports.
• Review assays/data for compliance to specifications and report abnormalities.
• Author, review, approve, and participate in qualification/validation protocols and analytical methods for testing group.
• Identify and lead continuous improvement projects, including special projects for analytical problem solving.
• Author and own deviations, CAPAs, and Change Controls.

Bothell, Washington

• Quality Control Representative on projects for clinical and commercial client products to manage GMP Drug Substance disposition.
• Track and plan analytical method validation via method transfer from Development team to QC for routine testing
• Author, review, and approve validation protocols and analytical methods for release assays
• Manage internal (QC Chemistry and Bioassay testing) and external (vendor) testing for lot release
• Generate CoAs after review of stability/release data for USP compendial, chemistry, and bioassay testing
• Work cooperatively with internal QA lot disposition team to ensure deliverables are met for lot release

Seattle, Washington, United States

• Collaborate in a Quality Control cGMP laboratory performing and analyzing complex laboratory analysis for early to late phase drug development
• Perform routine chemical and biochemical analyses of various stage drug products, bulk drug substance, and stability samples
• Review and approve testing data to ensure that all reported results met accuracy, compliance, and specification.
• Train and assign weekly assignments for QC Associates and upkeep of QC laboratory to ensure GMP compliance.
• Author SOP’s, analytical test methods, validation study protocols and reports
• Conduct/Review/Approve laboratory investigations.

Seattle, Washington, United States

• Same descriptions above with QC Scientist plus;
• Supervise/Train QC Associates and upkeep of QC laboratory to ensure GMP compliance.

Seattle, Washington, United States

• Collaborate in Quality Control cGMP laboratory in providing analyses with High Performance Liquid Chromatography (HPLC) and compendial methods for In-process, Release and Stability Samples or early to late phase drug.
• Authoring protocols (SOPs), executing validation process, and writing validation report.
• Upkeep, scheduling and execution of equipment maintenance.
• Water Testing of Facilities (pH, Conductivity, Endotoxin, TOC, and Microbial).
• Environmental Monitoring (Surface and Air Viable Testing)

Seattle, Washington, United States

• Support Research & Development of projects, pre-projects and various research efforts in providing proteins, antibodies, assays execution, and analyses.Laboratory experience include;
• Electrophoresis (SDS/native-PAGE, Western Blot)
• Comprehensive Assay Development (ORIGEN, ELISA)
• Cell Culture Sterile Techniques (Fusion, Cloning)
• Data Collection and Analyses (Softmax Pro, Excel)

Seattle, Washington, United States

• Support Research & Development of projects, pre-projects and various research efforts in providing proteins with large scale fermentation, recovery and purification.Laboratory experience include;
• Large Scale Fermentation (up to 1500L fermentation, inoculation, feeds, sample collection, SATT control system), Recovery (Dynomill, Centrifugation), and Purification (up to 100L Fast Flow chromatography matrices for.
• Clean Room maintenance (clean and maintain purification suite according to GMP regulation specifications))
• Sterile Techniques (Product sterilization, lyophilization, aliquotting)
• Inventory Control (Chemical, Supplies)