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Labcorp is a global leader in diagnostic testing and drug development solutions, helping healthcare providers, researchers, and patients make informed decisions that advance care. Join us in our mission to improve health and improve lives.

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. 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

• 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

• 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.

Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Employees regularly scheduled to work less than 20 hours, Casual, Intern, and Temporary employees are only eligible to participate in the 401(k) Plan. For more detailed information, please click here.

• Relocation assistance available.

Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.

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