Senior Manager, External Manufacturing

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 170,000 - 225,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in East Greenbush, NY is seeking a Senior Manager, External Manufacturing (Operations Lead) to drive day-to-day execution across the CMO network, ensure cGMP compliance, and lead a team focused on continuous improvement and technical excellence.

This role collaborates with EM project management, supports tech transfers, and leads site initiatives to reduce cycle times and improve manufacturing efficiency while maintaining product integrity.

Qualifications

• BS/BA in business or science with 8+ years in cGMP manufacturing (clinical or commercial).
• 5+ years leading manufacturing operations as part of a team.
• MBA (preferred).

Responsibilities

• Ensure product manufacture complies with cGMP and applicable regulations.
• Facilitate external manufacturing activities at CMOs, including scheduling, materials, shipments, and reports.
• Collaborate on tech transfers, validation plans, SOPs, and documentation.
• Lead continuous improvements and system implementations to reduce cycle times.
• Monitor inspections and safeguard product integrity across the supply chain.

Skills

cGMP manufacturing operations

Leadership

Education

BS/BA in business or scientific discipline

MBA preferred

Job description

Overview

Build our future together: 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.

Location: East Greenbush, NY | Work model: Monday–Friday, 8:00 a.m.–4:30 p.m. Travel: 25–50%.

Responsibilities

• Ensure product manufacture occurs in compliance with cGMP and applicable regulations.
• Facilitate all External Manufacturing activities at CMO/partner sites, including batch scheduling, material supply, direct shipment, cycle time tracking, reports, and technical expertise.
• Collaborate with EM Project Management to route/review technical transfer activities, validation plans, MRs, SOPs, and other documentation in a timely manner.
• Implement site initiatives in production operations as directed by site management.
• Lead continuous improvements, system implementations, and/or strategy development to reduce cycle times and improve efficiency for the area.
• Ensure off-site inspections, testing, and shipping/packaging are performed according to guidelines and specifications.
• Monitor cGMP compliance at contract manufacturers to safeguard product integrity and company reputation.
• Support investigations related to External Manufacturing or associated shipping operations as required.
• Manage direct reports and/or lead a sub-team in continuous process improvements, system/equipment implementation, and/or strategy development.
• Assist in developing metrics to analyze department activities, workload, and performance.
• Maintain required training status on Regeneron work instructions and SOPs.

Qualifications

• 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.

About Regeneron and EEO

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. We provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process where no undue hardship would result. Salary ranges are disclosed where required, and final offers are determined within the relevant range based on country, role level, and experience. CBAs may apply in some countries and can influence pay or benefits.

Regeneron offers a competitive 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) match, health and wellness programs, paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.