Jay Li

Exec Director @Biomea Fusion

Fremont, CA, US
EMAILS
j•••@biomeafusion.com
MOBILE NUMBERS
+14•••••••20

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WORK HISTORY

Aug 2025 — Present

Exec Director @Biomea Fusion

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San Carlos, CA, US

EDUCATION

N/A

Florida Atlantic University

Master of Science - MS

SKILLS

ValidationRegulatory SubmissionsRegulatory RequirementsPharmaceutics21 Cfr Part 11BiotechnologyComputer System ValidationChange ControlRegulatory AffairsQuality ControlGmpPharmaceutical IndustrySopFdaTechnology TransferHplcR&DQuality SystemV&VChromatographyCleaning ValidationGxpAseptic ProcessingMedical DevicesCapaDrug DeliveryLimsLaboratoryBiopharmaceuticalsTrackwiseGlp

ABOUT JAY LI

Proven Quality professional with 20+ years experience in the biotech, medical device and pharmaceutical industry with 15 years in manager/director position.Specialties: Extensive experience with FDA and other regulatory agencies. Leadership of projects resulted in the timely and successful start-up of Quality System, QC lab and Continues Improvement/Lean Process.Implemented SAP, LIMS and TrackWise

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