Mei Yang-Woytowitz

Director, Companion Diagnostics Project Management @Precision For Medicine

Towson, MD, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Mar 2024 — Present

Director, Companion Diagnostics Project Management @Precision For Medicine

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MD, US

Collaborate with multiple pharmaceutical companies and be responsible for developing and launching Companion Diagnostics (CDx) products for gene therapy drugs in the US, EU and the rest of the world- Lead cross functional team in assay transfer, assay validation, design control, Regulatory submissions, and commercial launch readiness of multiple products- Lead alliance management and strategic partnership activities with critical clients- Led multiple work streams to establish the first CDx commercial sample testing program in the company which has been launched in US, Europe, and being launched into the rest of the world- Lead commercial activities including patient sample testing, customer support, and life cycle management- Provide strategic guidance and priorities across the portfolio, recommend for allocating resources and budget to cross functional work stream, and ensure timely communication and resolution of escalated issues. Manage multiple program/project timeline, budget, and proposals.

SKILLS

Cell BiologyMedical DevicesClinical Study Site Ualification and InitiationProject ManagementBiotechnologyResearch and Development (R&D)FdaBiochemistryChemistrySpectroscopyDesign for Six SigmaLife SciencesProduct DevelopmentAssay DevelopmentTalent ManagementGmpNext Generation SequencingClinical Study DesignLiquid BiopsyValidationClinical StudyInnovation and DiscoveryMolecular & Cellular BiologyR&DCross-Functional Team LeadershipMicrobiologySystems EngineeringProtein ChemistryRegulatory AffairsDoeQuality SystemMolecular BiologyProduct InnovationU.s. Food and Drug Administration (Fda)In Vitro Diagnostics (Ivd)GeneticsCancer Genome DiagnosticsDesign ControlProgram ManagementPolymerase Chain Reaction (Pcr)

ABOUT MEI YANG-WOYTOWITZ

An expert in new product development, product life cycle management and product…

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