Yongchun Zhang

About Yongchun Zhang

A self-motivated problem solver with strong analytical skills and broad technical experience in cell therapy, mAb and recombinant protein manufacturing equipment, processes and facilities- Lead process engineer with 20 years of experience in GMP process and facility design, qualification and manufacturing support through the whole life cycle of multiple large capital projects- Established Subject Matter Expert (SME) in single-use technologies (SUT) with over 18 years in materials, equipment and suppliers selection, design and qualification. Led revamping of corporate business process for SUT qualification- Experienced project manager for developing and managing COGs reduction and continuous improvement projects.

Experience

1. Lead Process Engineer

   Bayer

   May 2018 — Present · Berkeley, CA, US

   Engineering Design Lead for 3D Allogeneic Cell Therapy Manufacturing Platform (08/22 – Present)o Guides and leads core-team on essential engineering concepts, documentation, and design aspectso Supports cell culture scale up considerations and associated engineering design parameterso Provides consumable/disposable/raw material expertise to the core-team and responsible for associated design deliverables• Lead Process Dev Engineer for 2D Cell Therapy Manufacturing Platform (01/2021 – 06/2022)o Developed concepts for media conditioning and liquid handlingo Identified and developed customized media project with suppliero Led global team to plan and execute development studies, align design between external partner, process development and capital project teamso Coordinate for consumables and equipment design, qualification and planning for development labo Filed patent for two new technologies to improve adherent cell culture performance• SUT SME and Lead Engineer for Upstream Process for an All-single-use mAb Manufacturing Facility in Berkeley, CA (05/2018 - 03/2023)o Design and qualification of process, equipment and consumable for Upstream Processo Led global cross-functional team to revamp Bayer’s SUT design, qualification and implementation process o Led cross-functional team to evaluate key manufacturing equipment including bioreactors and single-use mixerso Collaborate with multiple global sites within Bayer to develop an aligned manufacturing platform for mAb

Education

• Louisiana State University

  PhD, Chemical Engineering

  1997 — 2002

• Zhejiang University

  B.S., Chemical Engr/Process Control

  1991 — 1995

Skills

• Gmp Process & Eq. Design and Implementation
• Single-Use Systems
• Supplier Management
• Data Analysis
• Six Sigma
• Cip
• Gmp
• Chemical Engineering
• Process Modeling and Simulation
• Cross-Functional Team Leadership
• Technology Transfer
• Data Mining
• Project Management
• Bifurcation Analysis
• Process Simulation
• Process Design
• Process Optimization
• Risk Assessment
• Extractables & Leachables
• Project Dev. and Mgmt
• Root Cause Analysis
• Advanced Process Control