Sr. Manager Manufacturing And Operations Cdx

Labcorp

Morrisville, NC, USA
Base: $140k - $160k annually; bonus: eligible for ...
Onsite
Ivd companion diagnostic manufacturing
Fda ivdr iso 13485 regulatory compliance
Assay development and kit commercialization
Labcorp is seeking a Senior Manager for Manufacturing and Operations in Companion Diagnostics (CDx) to lead and grow their manufacturing function in Morrisville, NC. The ideal candidate should have extensive experience in IVD regulations, assay development, and team management while being hands-on and strategic in their approach

Job Summary

  • The role involves leading the development, manufacturing, and commercialization of IVD companion diagnostic kits from clinical trials through global launch in the US, EU, and RoW markets.
  • Candidates must ensure manufacturing operations comply with FDA, IVDR, and ISO 13485 standards while overseeing assay transfer, validation, and lifecycle management activities.
  • The position offers a competitive salary range of $140k-$160k annually, eligibility for an annual bonus, and comprehensive benefits including medical, dental, vision, and 401(k) matching.

Matching Summary

Match Score: 85

Labcorp is seeking a Senior Manager for Manufacturing and Operations in Companion Diagnostics (CDx) to lead and grow their manufacturing function in Morrisville, NC. The ideal candidate should have extensive experience in IVD regulations, assay development, and team management while being hands-on and strategic in their approach.

Salary

Base: $140k - $160k annually; Bonus: Eligible for annual bonus based on performance; Benefits: Medical, Dental, Vision, Life, STD/LTD, 401(k), PTO, Tuition Reimbursement

Skills & Requirements

Must-have

  • IVD companion diagnostic manufacturing
  • FDA IVDR ISO 13485 regulatory compliance
  • Assay development and kit commercialization
  • Manufacturing process validation and scale-up
  • Day-to-day manufacturing execution oversight

Nice-to-have

  • Supply chain and inventory management experience
  • Cross-functional leadership and influence skills
  • Ability to work under pressure and meet deadlines
  • Strong organizational and analytical planning skills

Key Requirements

  • Bachelor of Science degree required
  • 2+ years supervisory or management experience
  • 5+ years experience with IVD regulations and quality systems
  • 10+ years experience in assay development and kit commercialization
  • Experience with PeopleSoft, ERP systems, and shipping software

Work Rights

Not specified

Tailored Resume

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