Kyle Stoddard

Associate Director, Qa for Qc Compliance and Investigations Team @Genetix Biotherapeutics

Cambridge, MA, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Sep 2024 — Present

Associate Director, Qa for Qc Compliance and Investigations Team @Genetix Biotherapeutics

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Somerville, MA, US

Manage and Lead QC Compliance (QA for QC) Team responsible for QA Oversight and Support of Genetix/bluebird bio QC Testing supporting all clinical and commercial cell banks, plasmid, LVV, and Drug Products. QA Support of Method Lifecycle Management. Coordinate and Drive Quality Oversight Plan (QOP) for CTO and Draft and Revise bluebird bio/Genetix CTO quality agreements. QA Support of all QC owned QMS. Drive improvements to Lab Investigation (OOS, OOT, QC Trends, etc) process, procedure, communication and management. Routinely present metrics to QLT. Support DP Manufacturing Capacity Increase to exceed Genetix patient delivery goals for 2025.

EDUCATION

N/A

Bridgewater State College

Bachelor of Science - BS, Chemistry and Biology

SKILLS

Analytical Method ValidationSop DevelopmentLimsAnalytical ChemistryValidationMass SpectrometryTrackwiseChange ControlMethod TransferBiopharmaceuticalsLaboratory AutomationTechnical Writing21 Cfr Part 11Corrective and Preventive Action (Capa)Technology TransferGlpLean Six SigmaDeviationsCapaQuality SystemQuality SystemsProject ManagementComputer System ValidationLaboratory Information Management System (Lims)HplcLc-MsChromatographyInstrument ValidationBiotechnologyEquipment QualificationQuality AuditingAseptic ProcessingQuality ControlGmp

ABOUT KYLE STODDARD

Associate Director, Quality Assurance

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