Sr. Manager Manufacturing and Operations CDx

Labcorp•Morrisville, NC

9d•Onsite

About The Position

Labcorp is seeking a Senior Manager Manufacturing and Operations CDx to join our team in Morrisville, NC! The Senior Manager is a hands‑on CDx Manufacturing and Operations leader and will grow a small but critical Companion Diagnostics (CDx) manufacturing function. This role 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 position requires someone 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
Ability to effectively manage teams in a regulated environment
Ability to effectively perform organizational, analytical, planning, and computer skills
Ability to be effective in verbal and written communication skills
Ability to lead cross-functional initiatives and influence others
Ability to work independently and in a team environment with a professional and positive attitude
Ability to manage and maintain relationships with internal and external partners with professionalism and manage multiple concurrent studies each at a different stage
Ability to manage processes with high quality and master new techniques in an accelerated manner
Ability to work effectively and efficiently under pressure to organize work and meet scheduled deadlines
Ability to sit, stand, and walk for extended periods
Ability to pull, push, or lift of heavy objects up to 75lbs.

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