Hyojin Lee Email & Phone Number

California, United States

• Performed routine analysis of GxP samples across 10 testing methods for release and stability, ensuring compliance with GDP standards for documentation.• Played a pivotal role in multiple analytical method projects involving the ALLO-501A and ALLO-715 programs: - Cytokine release method’s validation and comparability. - Aberrant proliferation method qualification and Bridging study. - Method transfer of Cell count and viability, Cytokine release, and Aberrant proliferation.• Helped to ensure optimal laboratory operations by supporting logistical activities, including document archiving, sample and reagent receiving, lab equipment maintenance, instrument calibration, and reagent inventory management.• Successfully conducted and led multiple cross-training sessions with analysts in the QC Cell and Molecular Biology team and the QC Raw Material team of Allogene.• Maintain and cultivated four different cell lines used for Cytokine release and Cytotoxicity assay.• Helped to prepare a brand new QC laboratory for in-house testing in a CGMP environment.• Contributed to the ownership of deviation, change control, and method update processes.

• Part of a large-scale, multidisciplinary team that processes and manufactures reagents to formulateTaqPath COVID-19 Multiplex Diagnostic Solution.• Responsible for starting the manufacturing cycle of custom Oligonucleotides for use in the biotechindustry and TaqPath COVID-19 Multiplex Diagnostic Solution.• Manage the next production cycle process by evaluating and assessing ongoing product results.• Identify the cause of unwanted test results by troubleshooting equipment, methods, and processes.• Manage batch records, inventory, and hazardous rooms