Senior Manager, External Manufacturing
Regeneron
August 07, 2026
On-site
East Greenbush, NY
Operations
Discover Your Role
- Ensures product manufacture occurs in compliance with cGMP and applicable regulations.
- Facilitates External Manufacturing activities at CMO/partner sites: batch scheduling, supply of materials, direct shipment, cycle time tracking, reports, and technical expertise.
- Ensures timely routing/review of technical transfer activities, validation plans, MRs, SOPs, and other documentation in collaboration with EM Project Management.
- Implements site initiatives in production operations as directed by site management.
- Leads continuous improvements, system implementations, and/or strategy development to reduce cycle times and improve efficiency.
- Ensures off-site inspections, testing, and shipping/packaging follow guidelines and specifications.
- Assists in monitoring cGMP compliance at contract manufacturers to ensure product integrity and company reputation.
- Supports investigations related to External Manufacturing or associated shipping operations.
- Manages direct reports and/or leads a sub-team in continuous process improvements, system/equipment implementation, and/or strategy development.
- Assists in developing metrics to analyze department activities, workload, and performance.
- Maintains required training status on Regeneron work instructions and SOPs.
This Role Requires
- BS/BA in business or scientific discipline and 8 years of related experience, including a minimum of 5 years of direct cGMP manufacturing operations experience (clinical and/or commercial); remaining years may be satisfied through supplier management experience or equivalent combination of education and experience.
- MBA preferred.
Application Instructions
- Apply now.
- Ensures product manufacture occurs in compliance with cGMP and applicable regulations.
- Facilitates External Manufacturing activities at CMO/partner sites: batch scheduling, supply of materials, direct shipment, cycle time tracking, reports, and technical expertise.
- Ensures timely routing/review of technical transfer activities, validation plans, MRs, SOPs, and other documentation in collaboration with EM Project Management.
- Implements site initiatives in production operations as directed by site management.
- Leads continuous improvements, system implementations, and/or strategy development to reduce cycle times and improve efficiency.
- Ensures off-site inspections, testing, and shipping/packaging follow guidelines and specifications.
- Assists in monitoring cGMP compliance at contract manufacturers to ensure product integrity and company reputation.
- Supports investigations related to External Manufacturing or associated shipping operations.
- Manages direct reports and/or leads a sub-team in continuous process improvements, system/equipment implementation, and/or strategy development.
- Assists in developing metrics to analyze department activities, workload, and performance.
- Maintains required training status on Regeneron work instructions and SOPs.
This Role Requires
- BS/BA in business or scientific discipline and 8 years of related experience, including a minimum of 5 years of direct cGMP manufacturing operations experience (clinical and/or commercial); remaining years may be satisfied through supplier management experience or equivalent combination of education and experience.
- MBA preferred.
Application Instructions
- Apply now.