Justin T. Malone

Justin T. Malone

Head of Quality Assurance @WuXi Biologics

New York, NY, US
MOBILE NUMBERS
+12•••••••83

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WORK HISTORY

Nov 2024 — Present

Head of Quality Assurance @WuXi Biologics

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US

EDUCATION

2001 — 2005

Temple University

Bachlor of Science, Biology

2014 — 2015

Villanova University

Certificate, Applied Project Management

2010 — 2012

Manhattanville University

MS, Leadership and Strategic Management

SKILLS

GmpMedical DevicesCapaPresenterInoculationProcess QualificationTroubleshootingCell CultureMbr21 Cfr Part 11Aseptic ProcessingBatch RecordsAseptic TechniqueIso13485OqValidationPublic Speaking21 Cfr Part 820LeadershipStrategic LeadershipBioreactorSop DevelopmentBioreactorsPqEnvironmental MonitoringManufacturingProduct ManagementPowerpointBatch ProcessingIqBiotechnologyTeam LeadershipRegulatory AffairsSapUpstreamPharmaceutical IndustrySop

ABOUT JUSTIN T. MALONE

Biopharmaceutical professional with experience from Inoculum preparation to bioreactor operations and medical devices in cGMP environments. Attained my Masters degree in Leadership and Stragetic Management at Manhattanville College to advance my career through management.I would like to use my strong interpersonal skills and public speaking ability to further advance my career.Specialties: cGMP, Large Scale Manufacturing (LSM), Clinical Scale Manufacturing (CSM), Aseptic techniques,Medical Devices, SAP, Production Deadlines, Raw material implementation and ordering, Writing/Editing/Reviewing of Master Batch Records (MBRs) and Standard Operating Procedures (SOPs), implementation/closure of CAPAs and Environmental monitoring of cleanrooms.

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