Zichen Z.
Biopharma | CMC Data Science Leader | CPV, Stability, Spec Setting | FDA-facing Data Strategy | BLA & FDA Submission Support | Data Warehouse, Pipelines, Analytics, and Visualization |
- Role
- Principal Data Scientist at Replimune
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
Experience
Principal Data Scientist
Apr 2025 — Present
Led a team of 10 to build a CMC data warehouse, automating CPV and streamlining data from systems like EBR, LIMS, and CMS to Tableau- Designed an end-to-end automated data pipeline and developed a real-time dashboard now used daily in leadership scrum meetings to drive operational discussions and performance alignment- Drove CMC data strategy on FDA Information Request responses after BLA submission, ensuring timely and compliant delivery with the Regulatory team- Supported FDA Pre-License Inspection preparation and engagement, contributing to a successful outcome with only two minor regulatory observations- Oversaw statistical analysis (e.g. ANOVA, control charts, PCA etc.), addressing critical CMC issues such as Out-of-Spec/Trend (OOS/OOT) deviations and filtration clogging- Mentored junior scientists and analysts, fostering cross-functional collaboration and building CMC data capabilities across teams.
Education
Yale University
Master of Public Health - MPH, Chronic Disease Epidemiology
2016 — 2018
Wuhan University
Bachelor of Science (B.S.), Biology International Class
2011 — 2015
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