Sr. Manager Manufacturing and Operations CDx
On-site · Morrisville, North Carolina, United States
Job Summary
Senior Manager leads CDx manufacturing and operations for IVD companion diagnostics, developing, manufacturing, and commercializing CDx kits from clinical trials through global launch; oversees transfer, development, validation, and scale-up; manages day-to-day manufacturing execution, documentation, and lifecycle activities; ensures compliance with FDA, IVDR, ISO 13485 and global IVD requirements; coordinates material flow between departments; partners with cross-functional teams for regulatory support, audits, and post-market activities; builds scalable processes, documentation, and tools; trains manufacturing staff and represents CDx manufacturing in governance forums.
Required Qualifications
- Bachelor of Science degree
- 2+ years experience as a supervisor or manager
- 3+ years experience with PeopleSoft, ERP systems, Microsoft Office and FedEx Computer shipping software and hardware systems
- 5+ years experience with IVD regulations and quality systems (FDA, IVDR, ISO 13485)
- 10+ years experience in assay development and kit commercialization
- Able to lead cross-functional initiatives and regulatory submissions
- Ability to train and develop manufacturing staff
- Ability to work in a regulated environment and manage multiple concurrent studies
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.