Laura Pflug

Director, Product Support and Technical Operation @Kyowa Kirin, Inc.- U.S.

Trenton, NJ, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jan 2021 — Present

Director, Product Support and Technical Operation @Kyowa Kirin, Inc.- U.S.

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Princeton, NJ, US

Established the Technical Operations function in the North American Region and. Responsible for technology transfer and product support for commercial and pipeline product development including small molecule, biologics, and cell and gene therapy.

SKILLS

Drug DevelopmentBiopharmaceuticals21 Cfr Part 11Supply Chain ManagementCommercializationBiotechnologyProcess EngineeringDrug DiscoveryContract ManufacturingProcess OptimizationQuality ControlGmpProject ManagementPharmaceutical IndustrySopFdaGxpChemistryClinical SuppliesValidationChange ControlQuality SystemV&VClinical DevelopmentStrategic PlanningClinical TrialsSterility AssuranceGlpRegulatory AffairsLifesciencesU.s. Food and Drug Administration (Fda)CapaR&DProcess ImprovementTechnology TransferQuality AssuranceCmc Regulatory Affairs

ABOUT LAURA PFLUG

Accomplished Pharmaceutical Operations Executive and Leader with broad pharmaceutical and biotech experience. Specialties include CMC (Chemistry Manufacturing and Controls) Technical and Project Management knowledge and support including Analytical and Process Development, Quality Control, Quality Assurance, Technology Transfer, Manufacturing Operations, Validation, Supply Chain Management, Third-party Sourcing, along with drafting and review of Quality Modules for global regulatory filings.

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Laura Pflug — Director, Product Support and Technical Operation at Kyowa Kirin, Inc.- U.S. in Trenton, NJ, US | Unifers