External Manufacturing Ops Leader (cGMP)

Regeneron Pharmaceuticals, Inc.; New York (NY); On-site; USD 126,000 - 206,000; 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 our CMO network and lead a team focused on continuous improvement and technical excellence.

You will ensure cGMP compliance, manage batch scheduling, material supply, direct shipment, and technical transfers, while implementing site initiatives to reduce cycle times and improve efficiency.

Qualifications

• 8+ years of related experience including 5+ years 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 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.
• Supports investigations concerning External Manufacturing or associated shipping operations.
• Manages direct reports and/or leads a sub-team in continuous process improvements, system/equipment implementation and/or strategy development.

Education

BS/BA in business or scientific discipline

MBA

Job description

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

You will ensure cGMP compliance, manage batch scheduling, material supply, direct shipment, and technical transfers, while implementing site initiatives to reduce cycle times and improve efficiency.