External Manufacturing Operations Lead (Senior Manager)

Regeneron Pharmaceuticals, Inc.; Valley (AL); On-site; USD 126,000 - 206,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is 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 network.

You will lead a team focused on continuous improvement and technical excellence, ensuring cGMP compliance, managing batch scheduling, materials supply, and timely documentation across partner sites.

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). MBA preferred.

Responsibilities

• Ensures product manufacture occurs in compliance with cGMP and applicable regulations.
• Facilitates 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.

Education

BS/BA in business or scientific discipline

Job description

Regeneron Pharmaceuticals, Inc. is 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 network.

You will lead a team focused on continuous improvement and technical excellence, ensuring cGMP compliance, managing batch scheduling, materials supply, and timely documentation across partner sites.