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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 pe…
Skills: CDx Manufacturing, IVD Regulations, Assay Development, Kit Commercialization, ISO 13485
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Fayetteville, North Carolina, United States · On-site
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Greenville, North Carolina, United States · Remote Solely
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Durham, North Carolina, United States · Hybrid
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Durham, North Carolina, United States · On-site
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Guilford County, North Carolina, United States · On-site
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Orange, California, United States · On-site
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Holly Springs, North Carolina, United States · On-site
$137k–$185k/yr
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Newton, North Carolina, United States · On-site
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Raleigh, North Carolina, United States · On-site
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Pinetown, North Carolina, United States · On-site
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Newton, North Carolina, United States · On-site
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Connelly Springs, North Carolina, United States · On-site
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Santa Clara, California, United States · Hybrid
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Wilmington, North Carolina, United States · On-site
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Huntersville, North Carolina, United States · Remote OK
$120k–$140k/yr
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Belmont, North Carolina, United States · On-site
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Asheville, North Carolina, United States · On-site
$31/hr–$50/hr
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Morrisville, North Carolina, United States • On-site
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Lead the development, manufacturing, and commercialization of IVD companion diagnostic kits from clinical trials through global launch. Oversee facility readiness, ensure regulatory compliance, and manage day-to-day manufacturing execution and scale-up activities.
Requires a Bachelor of Science degree and over 10 years of experience in assay development and kit commercialization. Must have significant experience with IVD regulations (FDA, IVDR, ISO 13485) and at least 2 years of supervisory experience.
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!
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 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)
8 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.
At Labcorp, you can expect the following:
Innovative Environment: Join a leading healthcare organization committed to driving innovation through strategic investments to help improve health and improve lives.
Global Impact: Contribute to the future of healthcare by investing in pioneering companies that can transform patient care.
Collaborative Culture: Work in a dynamic, inclusive environment that values diverse perspectives and fosters collaboration.
Benefits: 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.
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.
If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.
Laboratory Corporation of America Holdings is a life sciences company that is integrated in guiding patient care, providing clinical laboratory and end-to-end drug development services. The Company operates as a healthcare diagnostics company. The Company operates through two segments: LabCorp Diagnostics (LCD) and Covance Drug Development (CDD). The LCD segment is an independent clinical laboratory business, which offers menu of frequently requested and specialty testing through an integrated network of primary and specialty laboratories across the United States. The CDD segment offers drug development services, and provides a range of drug research and development (R&D) and market access services to biopharmaceutical companies and medical device companies across the world. It serves a range of customers, including managed care organizations (MCOs), biopharmaceutical companies, governmental agencies, physicians and other healthcare providers.
Offices: 358 S MAIN ST, Burlington, North Carolina 27215-5837, us
View all jobs at Laboratory Corporation of America HoldingsBased on 2474 listings with disclosed salaries, most engineering jobs in North Carolina pay between $75k–$184k per year. Individual offers vary with seniority, company size, and specialization.
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