Summary
Overview
Work History
Education
Skills
Timeline
Generic

Ching Lee

Carlsbad

Summary

Position as Senior Leader or Executive in Manufacturing, Operations, or CMC where my leadership skills and experience can contribute to achieve company goals.

Experienced with strategic planning, team leadership, and operational excellence. Utilizes proven methodologies to drive business growth and enhance organizational performance. Track record of successfully leading diverse teams and managing complex projects.

Overview

32
32
years of professional experience

Work History

Sr Director MSAT

Kite Pharma
01.2020 - Current
  • Managing a team of 25 direct reports that includes group roles in MSAT Lab, Data Analytics, Tech Transfer/Lifecycle Management, Operation support and Automation
  • Manage staff by setting clear objectives and goals for the year ensuring alignment with company goals. Coach, mentor, and develop employees based on their development plan objectives.
  • Align with cross functional teams like Process Development, Supply Chain, Tech Transfer and Manufacturing to meet our yearly goals.
  • Plan and design site MSAT Lab in alignment with Technology Roadmap to seek new technical opportunities for process improvements and efficiencies.
  • My team looked for opportunities to improve current commercial process that includes aseptic operations through single use technology that will reduce process contamination during viral vector manufacturing.
  • Aligned tech transfer team on vector transfer to our site on various technical topics that includes product freezing strategy, media warming requirements, media mixing and expiry approach, and process validation.
  • Successfully executed our Process Qualification runs in Q3 2021 for one of our commercial vector products. Received FDA approval in Q4 2022.
  • Lead and implemented capability/capital project that enabled Oceanside to internalize and manufacture Lentiviral Vector
  • Standing member in Oceanside Site Leadership Team
  • Aligned tech transfer team on vector transfer to our site on various technical topics that includes product freezing strategy, media warming requirements, media mixing and expiry approach, and process validation.
  • Successfully executed our Process Qualification runs in Q3 2021 for one of our commercial vector products. Received FDA approval in Q4 2022.
  • Developed and implemented innovative strategies to optimize product development processes.

Principal Process Engineer Process Development

Kite Pharma
08.2018 - 02.2020
  • Technology Implementation Lead responsible for leading technology implementation to manufacturing sites.
  • Lead cross functional team on version 1 of a formulation fill unit with the objective to automate and close operations in manufacturing
  • Equipment was successfully implemented in Q1 2019 and used for process qualification
  • Lead cross functional team on version 2 of formulation fill unit with the objective to automate and close operations in CAR-T manufacturing
  • Successfully implemented to clinical manufacturing on September 2019. Collaborated with cross functional team members ensuring aligned user requirements, qualification and implementation strategies, and timelines
  • Prepared and presented to VP level governance team for milestone and gate reviews
  • Lead cross functional team for media scale up project with the objective to increase aseptic media preparation batch size to improve operating efficiency
  • Successfully presented to VP Governance to transition project to implementation phase in commercial manufacturing site
  • Performed detailed cost analysis on project. Managed one direct report for this project.
  • Lead internal cross functional team to develop technology implementation business process within our company to establish best practices. This includes SIPOC, RACI, and seeking alignment with cross functional management
  • Lead cross functional team in September 2018 to develop PD evaluation on Vector development in-house vs. continuing with contracting out work
  • Lead and facilitated workshop within Process Development to evaluate process improvement opportunities to reduce testing backlog within PD. Used OE principles (DMAIC) for our evaluation and this was completed in May 2019. Improvements include establishing Service Level agreement between Analytical Testing group and customers, Improved study planning, platform assays, and routing equipment maintenance schedules


Sr Project Manager, Technology/MSAT Group

Genentech
12.2008 - 08.2018
  • Responsible for managing our company's contract with external partner for a commercial Rheumatoid Arthritis drug ($2 Billion annual sales).
  • Entails leading cross functional team to align and resolve manufacturing, quality, shipping, and supply topics with our external partner
  • Negotiate with our external partners, when needed, on delivery of our contractual obligations
  • Prepare and present milestone updates to senior management
  • Lead drug substance commercial tech transfers consisting of aligning team members on transfer strategy, developing and tracking timelines/deliverables, managing project budget and resources, and escalating applicable challenges to site management. Prepare and present to network teams and senior management on project milestones and deliverables.
  • Lead efforts for facility fit assessments on potential new products to transfer to our site consisting of technical fit, budget and resource forecasting, and project timelines.
  • Manage our department projects in alignment with our site project portfolio. Driving efforts to potentially save $11k to 13k per run on two of our commercial products.
  • Tech transfer business process owner leading efforts to improve our Tech Transfer business processes with a goal to reduce our Tech Transfer timelines by 20 percent
  • Interim MSAT Head from January 2011 to May 2011 consisting of 25 staff members until permanent MSAT Associate Director was hired
  • Lead cross functional team in 2011 to complete over 70 process validation reports in time to meet submission timelines for Rheumatoid arthritis product.
  • Manage two Technical Writers responsible for revising batch records and study protocols for Clinical manufacturing and updating process validation reports needed for commercial filing for Rheumatoid Arthritis product

Manager/Scientist II Tech Transfer/Process Development

Biogen Idec
07.2005 - 12.2008
  • Manage four direct reports in Cell Culture Biopharm Development group responsible for tech transfers to manufacturing facilities
  • My team successfully transferred six clinical products, one commercial product, and one late stage product into manufacturing over a 3 year period. Work consisted of facility fit studies with small scale bioreactors. Working with PD cell culture group on characterization study plans, establishing process limits for inoculation densities, feed timing, and harvest timing, and antifoam limits.
  • Streamlined our tech transfers by implementing tech transfer business processes and templates for protocols and reports
  • Performed Vendor/Supplier technical audits for raw materials used in process development and manufacturing
  • Provided manufacturing floor support as technical subject matter expert during tech transfers, engineering runs, and qualification runs
  • Supported Japanese Audit as technical expert for one of our commercial products
  • Authored, updated, revised, and reviewed sections for Regulatory filings (IND, BLA, FDA responses)


Scientist I Tech Transfer/Process Development

Biogen Idec
07.2002 - 07.2005
  • Responsible for leading tech transfers into our Oceanside manufacturing facility.
  • Developed process descriptions used for tech transfers
  • Worked closely with manufacturing in drafting, reviewing, and approving batch records used for Engineering run and Qualification runs
  • Provided on-floor support, as cell culture SME, during tech transfers and start up runs
  • Planned and executed small scale 5L bioreactor studies to support tech transfers; example satellite runs, media hold studies
  • Performed assessments on deviations and investigations from manufacturing campaigns. Compared manufacturing process data vs. Development data ensuring comparability by using SIMCA-P data tool.
  • Reviewed and approved batch records for the GMP cell banking area
  • Managed one direct report

Manufacturing Supervisor

Amgen
01.2001 - 07.2002
  • Supervised 5 direct reports in fermentation (E.coli and mammalian) clinical and commercial manufacturing
  • Managed our production shift schedule for our group during manufacturing campaigns
  • Successfully executed process and cleaning validation for two of our commercial products
  • Assessed and resolved deviations from manufacturing campaigns
  • Reviewed and approved production batch records during manufacturing campaigns
  • New Product Introduction lead for a fermentation process that was successfully transferred into clinical manufacturing

Manufacturing Associate II

Amgen
07.1998 - 01.2001
  • Fermentation area lead in clinical and commercial manufacturing responsible for scheduling and executing production activities
  • Trained staff on critical manufacturing operations and equipment that included bioreactor operations, aseptic techniques, microfiltration, Westphalia centrifuge and gaulin homogenizers
  • Responsible for coordinating QC samples during campaigns ensuring correct labels are generated, samples taken and delivered to QC, and results were obtained in timely manner for batch release
  • Review production batch records, assessed deviations, and organized process data to close out lots
  • Responsible for authoring Annual Product Reviews for a commercial product


Quality Control Associate II

Amgen
07.1993 - 07.1998
  • QC Microbiology Lead responsible for testing manufacturing samples for microbial contamination using Vitek, API, and NFT strips
  • Lead Sterility testing area that included daily testing schedules, perform testing on in process, drug substance, and drug product fill samples. Reviewed and approved test results
  • Responsible for generating monthly reports for management review and auditing sterility area for compliance
  • Performed media verification testing (Bacteriostasis/Fungistasis Testing)

Education

Master in Business Administration - MBA

California State Northridge
Northridge, CA
01.2001

BS - Microbiology, Minor Chemistry

California State Long Beach
Long Beach, CA
01.1993

Skills

  • Collaborative leadership
  • Culture transformation
  • Team management
  • Policy development

Timeline

Sr Director MSAT

Kite Pharma
01.2020 - Current

Principal Process Engineer Process Development

Kite Pharma
08.2018 - 02.2020

Sr Project Manager, Technology/MSAT Group

Genentech
12.2008 - 08.2018

Manager/Scientist II Tech Transfer/Process Development

Biogen Idec
07.2005 - 12.2008

Scientist I Tech Transfer/Process Development

Biogen Idec
07.2002 - 07.2005

Manufacturing Supervisor

Amgen
01.2001 - 07.2002

Manufacturing Associate II

Amgen
07.1998 - 01.2001

Quality Control Associate II

Amgen
07.1993 - 07.1998

BS - Microbiology, Minor Chemistry

California State Long Beach

Master in Business Administration - MBA

California State Northridge

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Ching Lee