Senior Manager, External Manufacturing

Regeneron Pharmaceuticals • Valley, AL

1d • $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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager