Senior Manager, External Manufacturing
Regeneron Pharmaceuticals • Valley, AL29d • $126,300 - $206,100 • Onsite
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Senior Manager, External Manufacturing
Regeneron Pharmaceuticals•Valley, AL
•$126,300 - $206,100•Onsite
About The Position
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, External Manufacturing (Operations Lead) to drive day-to-day execution, operational readiness, and world-class performance across our Contract Manufacturing Organization (CMO) network while leading a team focused on continuous improvement and technical excellence.
Requirements
- 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.
Nice To Haves
- MBA preferred.
Responsibilities
- Ensures product manufacture occurs in compliance with cGMP and applicable regulations.
- Facilitates all External Manufacturing activities at CMO/partner sites: batch scheduling, supply of materials, direct shipment, cycle time tracking, reports and technical expertise.
- Ensures, in collaboration with EM Project Management, timely routing/review of technical transfer activities, validation plans, MRs, SOPs, and other documentation.
- Implements site initiatives in production operation as directed by site management.
- Leads continuous improvements, system implementations and/or strategy development to reduce cycle times and improve efficiency for area.
- Ensures off-site inspections, testing and shipping/packaging is done according to guidelines and specifications.
- Ensures product integrity and company reputation by assisting in the monitoring of cGMP compliance at contract manufacturers.
- Supports investigations which concern External Manufacturing or associated shipping operations, as required.
- Manages direct reports and/or lead 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 specific work instructions and SOPs.
Benefits
- annual bonuses or other incentive plans
- equity awards
- pension or retirement benefits
- 401(k) company match
- health and wellness programs
- fitness centers
- insurance benefits (e.g. medical, dental, vision, life and disability)
- paid time off
- family support benefits
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What This Job Offers
Job Type
Full-time
Career Level
Manager
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