Sr. Manager Manufacturing And Operations Cdx

Lauer Kim Laboratory

Morrisville, NC, USA
Base: $140k - $160k annually; bonus: eligible for ...
Not specified
Ivd regulations and quality systems
Fda, ivdr, iso 13485 compliance
Assay development and kit commercialization
Labcorp is seeking a Senior Manager for Manufacturing and Operations CDx to lead the development and commercialization of companion diagnostic kits in Morrisville, NC. The role involves overseeing manufacturing processes, ensuring compliance with regulations, and collaborating with cross-functional teams while providing leadership for a growing team

Job Summary

  • The role involves leading a small but critical Companion Diagnostics manufacturing function to grow the portfolio from clinical trials through global launch in the US, EU, and RoW markets.
  • Candidates must ensure manufacturing operations comply with applicable regulations including FDA, IVDR, ISO 13485, and global IVD requirements while managing day-to-day technical work.
  • The position offers a competitive salary range of $140k - $160k annually along with comprehensive benefits including medical, dental, vision, 401(k), and relocation assistance.

Matching Summary

Match Score: 85

Labcorp is seeking a Senior Manager for Manufacturing and Operations CDx to lead the development and commercialization of companion diagnostic kits in Morrisville, NC. The role involves overseeing manufacturing processes, ensuring compliance with regulations, and collaborating with cross-functional teams while providing leadership for a growing team.

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 regulations and quality systems
  • FDA, IVDR, ISO 13485 compliance
  • Assay development and kit commercialization
  • Manufacturing process development and validation
  • Day-to-day manufacturing execution

Nice-to-have

  • Supply chain management experience
  • Production inventory management skills
  • Cross-functional leadership abilities
  • Scalable foundation building capabilities
  • Positive attitude under pressure

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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