Sr. Manager IVD Manufacturing and Operations CDx

Labcorp is a leader in diagnostics, drug development and healthcare innovation. Across every role, we harness data and AI to work smarter, move faster and create breakthrough solutions that improve health outcomes for people. With our global scale and deep expertise, you'll do meaningful work, grow your career and make a real impact. Together, we're improving health and improving lives.

Labcorp is seeking a Senior Manager IVD Manufacturing and Operations CDx to join our team in Morrisville, NC!

Job Responsibilities:

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.

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 which includes:

• 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

Minimum Qualifications:

• Bachelor of Science degree

• 2 or more years of experience as a supervisor or manager

• 3 or more years of experience with People Soft, ERP systems, Microsoft Office and Fed Ex Computer shipping software and hardware systems

• 5 or more years of experience with IVD regulations and quality systems (FDA, IVDR, ISO 13485)

• 8 or more years of experience in assay development and kit commercialization

Preferred Qualifications:

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

Additional Job Standards:

• 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.

At Labcorp, you can expect the following:

• Innovative Environment:
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