Senior Manager, External Manufacturing

Location: East Greenbush, NY
Work model: Monday-Friday, 8am-4:30pm
Travel requirement: 25-50%

About the Role

• 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.

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.
• MBA preferred.

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: 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, and family support benefits.

Pay

Salary Range (annually): $126,300.00 - $206,100.00