Katherine Kim
Los Angeles,CA
Summary
Results-driven Quality Professional with proven expertise leading cross-functional teams and maturing global programs at Kite Pharma. Demonstrated success in risk management, operational excellence, high productivity, and efficient workstream completion.
Overview
11
11
years of professional experience
Work History
Sr QC Specialist, Global QC Analytical Life Cycle Management
Kite Pharma
Santa Monica, CA
01.2022 - Current
- Analytical Method Validation & Transfer Program Owner - Ensure global procedures align with regulatory standards (ICH, USP, Eudralex) and industry best practices. Established framework for document standardization across the program including validation project plans, test protocol and report templates, and standardized documentation for training and exceptional conditions
- Facilitated the introduction of analytical technologies across commercial QC and manufacturing networks, partnering with Strategic Sourcing, Supply Chain, External Quality, QA, and Supplier Quality to enable in-line testing capabilities.
- Global Risk Lead - Facilitated global risk assessments & root cause investigations
- SME advisor for analytical method optimization to support commercial production enhancements.
- Drive global global quality records change control, deviation, & CAPA to ensure compliance and complete continuous improvement initiatives across the QC network; partnered with the global Head of Laboratory Controls & Quality Systems to establish a templated approach for analytical method and technology change controls.
- Author technical documents (Global Control Trend Report, Annual Product Review, & Global Proficiency Assessment Report).
- Global Impact Assessor - evaluate the global changes for impact to the global sample plans and validated state of analytical release methods to ensure seamless implementation and maintain product quality across the manufacturing network.
Quality Control Associate, Product Analytical & Bioassay Testing
Genentech
Vacaville, CA
01.2019 - 01.2022
- Potency Analytical Method Transfer Lead - Provided cell culture and bioassay technical leadership to internal and external partners, supporting method validation, transfer, and troubleshooting initiatives to ensure reliable method execution
- Championed continuous improvement initiatives through Root Cause Analysis, achieving 70-minute efficiency gain per analyst per test session in Make-Assess-Release operations.
- Ad Interim Supervisor – Led team of 14 QC analysts
- Spearheaded redesign of new hire training program, delivering 80% reduction in time-to-contribution (6 months to 4 weeks) and achieving ~$60K cost savings per hire.
- Analytical Testing Portfolio Manager - Drove resource optimization and capacity planning while negotiating cross-functional commitments with global counterparts to deliver on time organizational priorities and operational alignment.
- Functional area SME for regulatory inspection
Quality Control Analyst (Contractor), Laboratory Systems
Genentech
Vacaville, CA
01.2018 - 01.2019
- Partnered with cross-functional teams to drive successful implementation of enterprise Learning Management Systems across QC and site operations.
- Led transformation of QC training management model, streamlining administrative processes to enhance operational efficiency.
- Directed new hire onboarding operations and executed compliance audits to ensure regulatory adherence and seamless personnel integration.
Staff Research Associate
Vium Inc.
Milpitas, CA
01.2018 - 12.2018
- Executed in-vivo scientific studies with husbandry support, authored technical reports to communicate experimental findings, and conducted literature reviews to identify therapeutic candidate failures related to inadequate preclinical data.
Junior Specialist, Bauman Laboratory
UC Davis Center for Neuroscience
Davis, CA
01.2015 - 12.2017
- Conducted studies on the effects of maternal immune activation on brain and behavioral development.
Education
Certificate - Project Management
University of California, Davis
03.2024
BS - Animal Science
University of California, Davis
06.2015
Skills
- Analytical Method Validation & Transfer
- Veeva QMS
- Project Management
- Change Management
- Risk Management
- Global Document Standardization
- Technical Writing
Timeline
Sr QC Specialist, Global QC Analytical Life Cycle Management
Kite Pharma
01.2022 - Current
Quality Control Associate, Product Analytical & Bioassay Testing
Genentech
01.2019 - 01.2022
Quality Control Analyst (Contractor), Laboratory Systems
Genentech
01.2018 - 01.2019
Staff Research Associate
Vium Inc.
01.2018 - 12.2018
Junior Specialist, Bauman Laboratory
UC Davis Center for Neuroscience
01.2015 - 12.2017
Certificate - Project Management
University of California, Davis
BS - Animal Science
University of California, Davis