Kate S. Lee, Pmp Email & Phone Number

Provide quality oversight for the technical transfer, process qualification, operation and lifecycle management of cGMP manufacturing and testing at CDMOs to meet timely delivery to clinics and regulatory submission

Global

Responsible for developing the strategy for Process Validation and Controls and manage execution of validation/qualification activities throughout the PV lifecycle to support regulatory filings, product launches, market expansions and implementation of post-marketing and regulatory commitments. Lead cross-functional teams for technical transfers and/or.

Greater Los Angeles Area

• Led a new team of data scientists to execute enhanced process monitoring program according to the FDA's guidance on the Continued Process Verification (CPV). Accomplishments include:
• Developing CPV strategy and successfully implementing Statistical Process Controls using BIOVIA Discoverant for improved data aggregation and automatic trend notification, reducing 70% of manual work and preventing.
• Facilitating cross-functional/site trend review meetings, reporting out predicted failure rates to management and driving investigations to mitigate adverse trends
• Driving global harmonization of CPV strategy and operating mechanism and helping draft global procedure
• Performing MultiVariate Data Analysis (MVDA) to solve complex issues and aide predictive process modeling
• Implementing risk management policies according to FDA, EMA and ICH requirements and training teams on appropriate use of risk management tools such as Stature and process FMEA (PFMEA)

Los Angeles

• CAPA Investigation: Using six sigma DMAIC tools, successfully closed Bioburden CAPA with 100% effectiveness, resulting in hard savings of $1.8M and a new stable, predictable manufacturing process with sustained > 90%.
• Strategy and Leadership: In lieu of the Director, responsible for tactical development and implementation of key initiatives for the 2014 LA Compliance Excellence Playbook and assuring alignment with Division and.
• Project Management and Facilitation: Coordinated cross-functional teams to manage complex projects and successful closure of various CAPAs (Aseptic Filling, Drug Product Bioburden, Downstream Atypical Filtration)
• Change Agent: Demonstrated effectiveness in cultural change management through hands-on collaboration with manufacturing floor on CAPA investigations, document changes, Bioburden and GMP training, and implementation of.

Greater Los Angeles Area

• Managed six direct report Quality Associates on five shifts for uninterrupted Drug Substance manufacturing
• Ensured complete Quality review of batch records and Critical Systems to facilitate > 95% on-time product release
• Through the development of Quality & Manufacturing Value Stream Map (VSM) and effective execution via visual management on the floor and for management, improved the cycle time of immunoglobulin products to customers.

• Managed six employees and operation of QM Lab Logistics & Support department. Assisted in managing the department budget by prioritizing non-routine tests
• Drove Lean culture in QM Labs through various Continuous Improvement activities using Lean and six sigma tools. Proven track record of producing sustained improvements directly linked to VSM
• Collaborated with multiple business units in creating the current and future LA/Van Nuys Plant VSMs. Aligned QM Lab’s VSM and reported progress to management
• Represented QM Labs and received Division award for exemplary work for two consecutive years (2009 & 2010)
• Planned, executed and directed cross-functional and cross-facility top project to develop a robust Preventive Maintenance system and SOP for lab instruments

Greater Los Angeles Area

• Led team of 10 analysts s to ensure continuous Environmental Monitoring (EM) of Aseptic Fill activities
• Reviewed lab-generated test results. Created and revised SOPs and provided training to all employees
• Wrote investigation reports and implemented corrective actions for exceptions
• Streamlined the Media Fill Inspection process through cross-functional Kaizen
• Managed annual ISO 5/7 Gown Qualification for all employees at Los Angeles plant

Greater Los Angeles Area

• Supported manufacturing for the conformance runs and approval of the new plasma fractionation facility (Building 5). Trained and supervised the new grave shift
• Conducted biochemical analyses of in-process samples and performed EM
• Maintained calibrations of all B5 laboratory equipment
• Reviewed lab data to ensure accuracy and investigated deviations

Berkeley, CA

• Analyzed structure of AQP0 aquaporin in erythrocyte membrane to determine its function, using affinity chromatography and X-ray diffraction crystallography
• Collaborated in summarizing results and writing report for publicationPUBLICATION(2006) Water transport in AQP0 aquaporin: molecular dynamics studies. Journal of molecular biology, 360(2):285-96.