Senior Manager, External Manufacturing

Regeneron Pharmaceuticals • Valley, AL

2d • $126,300 - $206,100 • Onsite

About The Position

Regeneron is seeking a Senior Manager, External Manufacturing (Operations Lead) to drive day-to-day execution, operational readiness, and performance across its Contract Manufacturing Organization (CMO) network. The role leads a team focused on continuous improvement and technical excellence and is based in East Greenbush, New York. The work schedule is Monday through Friday, 8:00 a.m. to 4:30 p.m., with a travel requirement of 25–50%.

Requirements

• Bachelor’s degree in business or a scientific discipline.
• Eight years of related experience, including at least five years of direct cGMP manufacturing operations experience in clinical and/or commercial manufacturing.
• Remaining experience may be satisfied through supplier management experience or an equivalent combination of education and experience.

Nice To Haves

• MBA.

Responsibilities

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

Benefits

• Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits.
• Reasonable accommodation during recruitment for applicants with known disabilities or chronic illnesses, where required and unless it would impose undue hardship.

What This Job Offers

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