Sr. Manager Manufacturing and Operations CDx

Labcorp•Morrisville, NC

1d•Onsite

About The Position

Labcorp is seeking a Senior Manager Manufacturing and Operations CDx to join their team in Morrisville, NC. This role is a hands-on CDx Manufacturing and Operations leader responsible for growing a critical Companion Diagnostics (CDx) manufacturing function. The position will work alongside an existing team member and will be directly responsible for the development, manufacturing, and commercialization of IVD companion diagnostic kits from clinical trials through global launch (US, EU, and RoW). This role requires an individual who can execute day-to-day technical work while also providing vision and leadership to evolve processes, infrastructure, and capabilities as the CDx portfolio expands.

Requirements

Bachelor of Science degree
2 or more years of experience as a supervisor or manager
3 or more years of experience with PeopleSoft, ERP systems, Microsoft Office and FedEx Computer shipping software and hardware systems
5 or more years of experience with IVD regulations and quality systems (FDA, IVDR, ISO 13485)
10 or more years of experience in assay development and kit commercialization

Nice To Haves

5 or more years of experience with supply chain management, production, inventory management, manufacturing or logistics utilizing batch records

Responsibilities

Lead manufacturing operations and ensure facility readiness in direct support of the development, manufacturing, and commercialization of IVD/CDx kits used in clinical trials and commercial launch for US, EU, and ROW markets.
Ensure manufacturing operations comply with applicable regulations and standards, including FDA, IVDR, ISO 13485, and global IVD requirements.
Perform and oversee assay transfer, manufacturing process development, validation, and scale-up activities.
Own day-to-day manufacturing execution, troubleshooting, documentation, and lifecycle management activities in a small-team environment.
Manufacturing of kits and preparation of final packaging of IVD products and PM activities for shipment to clients and/or Field Service Technicians.
Coordinating and expediting the flow of materials and assemblies between departments, according to production and shipping schedules or department priorities.
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.
Be an active member of internal project team, including participating in project-set up activities and team meetings.
Represent the CDx manufacturing function in internal governance forums.
Build scalable foundations (processes, documentation, tools) appropriate for a growing organization.
Training and ensuring competency of manufacturing staff.