Sr. Manager IVD Manufacturing and Operations CDx
Core
Lead manufacturing operations and ensure facility readiness for the development, manufacturing, and commercialization of IVD companion diagnostic kits from clinical trials through global launch.
Role type
Senior Manager, IVD Manufacturing and Operations
Builds
Companion Diagnostics (CDx) manufacturing function and IVD/CDx kits
Domain
Healthcare diagnostics / In Vitro Diagnostics (IVD)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
IVD regulations and quality systems (FDA, IVDR, ISO 13485), assay development, kit commercialization, manufacturing process development, validation, scale-up, manufacturing execution, troubleshooting, documentation, lifecycle management, supply chain management, production, inventory management, logistics, batch records, PeopleSoft, ERP systems, Microsoft Office, FedEx Computer shipping software and hardware systems
Preferred skills
supply chain management, production, inventory management, manufacturing or logistics utilizing batch records
Technologies
PeopleSoft, ERP systems, Microsoft Office, FedEx Computer shipping software and hardware systems
Responsibilities
Ensure manufacturing operations comply with applicable regulations and standards, Perform and oversee assay transfer, manufacturing process development, validation, and scale-up activities, Manufacturing of kits and preparation of final packaging of IVD products, Coordinating and expediting the flow of materials and assemblies between departments, Partner with cross-functional teams to regulatory support submissions, internal and external audits, and post-market activities, Establish metrics and KPIs to track performance, quality, and delivery, Training and ensuring competency of manufacturing staff
Seniority
Senior, hands-on IC with leadership responsibilities
