Operations Excellence Lead
4 days ago
Job Description:
The Operations Excellence Lead will play a critical role in leading our Contract Manufacturing Organization (CMO) relationships and facilitating day-to-day operations with external manufacturing partners. This individual will focus on strategically leading business relationships with CMOs and Partners through the External Manufacturing Team, ensuring world-class performance of Industrial Operations & Product Supply (IOPS) product supply chains.
This role involves developing and maintaining strong relationships with CMOs and Partners, facilitating all External Manufacturing activities, scheduling batches, supplying materials, and directing shipments of bulk and finished product at manufacturing sites. The successful candidate will track and supervise cycle times, provide technical expertise, and form strategic partnerships with internal stakeholders.
- Main Responsibilities:
- Lead business relationships with CMOs and Partners.
- Facilitate all External Manufacturing activities at contract and/or business partner manufacturing sites.
- Develop and implement strategies to improve operations excellence.
- Collaborate with internal stakeholders to optimize collaboration and improve overall performance.
- Liaise between Regeneron's Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments, and contract manufacturers or business partners.
- Collaborate with New Product Launch Teams and Life Cycle Management Teams for efficient product launches.
- Ensure timely routing and review of technical transfer activities with the External Manufacturing Project Management team.
- Collaborate on validation plans, MRs, SOPs, and other necessary documentation for clinical and commercial external manufacturing activities.
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