Ernest Chen

 Lead a team of 8 Associates to ensure Manufacturing Operations met the required levels of safety, quality and productivity through optimizing manufacturing output and labor efficiency  Responsible for Team’s Individual Development and Strategic Team Roadmap  Build an effective succession planning roadmap by development of capable individuals in Leadership Role  Implement, enforce and take ownership on all Safety, Health & Environmental (SHE) requirements and initiatives within Team.  Make recommendations to management on matters relating to human resources, budget and department operations.  Support the development of the production plan for the area and ensure conformance with production schedules and delivery target  Promote problem identification and a culture of proactive problem prevention  Drive cross-functional continuous improvement projects – including improvements in Maintenance Schedule and Lead Time, On-Time Batch Records Delivery

 Lead a team of 12 Biotechnologists to ensure Manufacturing Operations met the required levels of safety, quality and productivity through optimizing manufacturing output and labor efficiency  Responsible for Team’s Individual Development and Strategic Team Roadmap  Build an effective succession planning roadmap by development of capable individuals in Leadership Role – 3 Leads and 1 Acting Supervisor  Partner with Compliance team as a subject matter expert (SME) for Manufacturing Operations to support Health Authority audits (FDA, EMA, MFDS, CFDA, HSA)  Implement, enforce and take ownership on all Safety, Health & Environmental (SHE) requirements and initiatives within Team  Make recommendations to management on matters relating to human resources, budget and department operations.  Support the development of the production plan for the area and ensure conformance with production schedules and delivery target  Promote problem identification and a culture of proactive problem prevention  Refining validation strategy, investigations and technical transfers  Drive cross-functional continuous improvement projects – including improvements in Maintenance Schedule and Lead Time, On-Time Batch Records Delivery  Drive productivity/cost-savings through Vendor Selections and Troubleshooting Efforts

 Led a team of 10 Biotechnologists to drive daily operations on-time delivery through effective planning and execution  Responsible for Individual Development and Strategic Team Development  Experienced in Upstream E-coli Cell Culture and Downstream E-coli Purification  Provided trainings to new hire on Manufacturing Operations  Partner with Maintenance and Scheduling team to drive effective workforce management in Maintenance and Production schedule  Technical Lead for Level 1 troubleshooting of equipment/process  Led creation of Manufacturing SOP (standard operating procedure) / OJT(on-the-job training)  Technical Assessor/Approver and Subject Matter Expert in Trackwise Change Control System  Drove CAPA (Corrective Action/Preventive Action), Discrepancies and Investigation Closure  Led Continuous Improvements Initiatives – including Scrap/Waste Reduction, ipads Usage, Manufacturing Biotechnologist Minimum Night Shift and Yield Improvement

EDB - STRATEGIC ATTACHMENT & TRAINING (STRAT) PROGRAMME - Support e-coli biologics production - Downstream Purification - Adhere to cGMP Compliance and cGDP - Involvement in both Commercial and Clinical Production - Proficient in SAP, IP21, LIMS