Louis Tse

About Louis Tse

Supply Chain and Packaging Engineering Leader in Cell and Gene Cell Therapy, Biotech, and Pharmaceuticals. Proven track record delivering results from clinical to commercialization.Package Design, Development & QualificationShipping Validation Cryogenic & Cold Chain Temperature ControlLane Mapping Real Time Shipping Condition Monitoring Process OptimizationMaterial InnovationSustainabilityASTM ISTA CFR

Experience

1. Sr Packaging Engineer Ii

   Kite Pharma

   Feb 2020 — Present · Boston, MA, US

   Single point of contact on launch teams that managed and led cross-functional engagement with Quality, Regulatory, Supply Chain, and Commercials teams for end-to-end packaging development for apheresis, vector, starting materials, and final product ensuring manufacturing performance and regulatory compliance-Spearheaded initiative across global manufacturing sites in North America and Europe to implement new printing technologies and led capital project analysis with Finance teams for executive leadership approval-Set up project plans in Smartsheets and coordinated activities with global stakeholders to introduce new labeling and printing equipment from feasibility, procurement, qualification, and phased production deployment-Identified opportunities to innovate secondary packaging for cell therapies using sustainable materials such as paper pulp, recyclable foams, injection molded plastics and implemented new packaging that differentiated branding and resulted in over $1M cost savings-Qualified new insulated shipping containers to support domestic and international shipping requirements and led DQ/OQ/PQ qualification testing of -20°C, 2-8°C, and -150°C LN2 cold chain shipping systems following ASTM, ISTA, 49CFR standards to ensure global GMP compliance-Owned global change controls and collaborated with other regional stakeholders to ensure seamless execution and implementation-Authored SOPs, WIs, and technical reports supporting global regulatory submissions (including BLA/MAA)-Conducted vendor assessments and onboarded new vendors for labeling and secondary packaging-Owned and managed deviations, investigations, SCAR, RCA, and CAPA-Led process improvements across manufacturing sites and implemented risk mitigation to eliminate faulty label application.

Education

• University of Washington

  Master of Science (M.S.), Supply Chain Transportation and Logistics

  2015 — 2017

• University of Washington

  Certificate, Project Management

  2012

• Michigan State University

  Bachelor of Science (B.S.), Packaging

  2003 — 2007