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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