Hilary Chan

About Hilary Chan

Biopharmaceutical industry experience in process engineering, plant engineering, and compliance. Process engineer accomplished in supporting the make/assess/release of drug substance in cell culture and protein purification. Demonstrated success in leading CapEx and cross functional continuous improvement projects as a project manager, equipment qualification engineer, and automation engineer. Experienced in DeltaV DCS through training, troubleshooting, and implementing automation solutions.• Clinical/Commercial CHO Cell Culture and Protein Purification • Single-use technology • Capital Projects• Equipment Troubleshooting• DeltaV Implementation (7009) and Batch Implementation (7016)• Equipment commissioning and qualification• Process Validation • Audits and inspections

Experience

1. Process Engineer

   Genentech

   Jun 2021 — Present

   Clinical and Commercial Drug Substance Manufacturing SME• Upstream SME supporting the production of clinical and commercial molecules by identifying process improvements, providing technical assessments, implementing changes, ensuring campaign readiness, providing manufacturing technical support, participating in troubleshooting, and supporting impact/root cause assessments• Downstream SME identifying areas of improvement to mitigate sustained bioburden issues, ensuring campaign readiness, and providing manufacturing technical support associated with a commercial process• Analyzing manufacturing data and trends to support drug substance manufacturing operations (upstream and downstream), process discrepancies, and investigationsProcess Validation• Led a process validation study for membrane carryover to increase the number of TFF cassette uses and saved the site $270k in material costs• Authored process validation reports, analyzing process performance and product quality data to support regulatory filingTechnical and Compliance Improvements• Representing South San Francisco Production as the site’s upstream SME in a global network team focused on driving continuous improvement and standardization of cell culture unit operations across sites• SME in a cross-functional team that assessed manufacturing issues impacting reliability in the plant and determined approaches to prioritize and reduce defects

Education

• University of California, Davis

  Bachelor of Science (BS), Biochemical Engineering

Skills

• Statistics
• Data Analysis
• Microsoft Office
• Microsoft Excel
• Powerpoint
• Research
• Laboratory
• Microsoft Word
• Matlab
• Gel Electrophoresis
• Science
• Pcr
• Cell Culture
• Public Speaking