External Manufacturing Operations Lead

Regeneron Pharmaceuticals, Inc.; Town of East Greenbush (NY); Presencial; USD 126.000 - 206.000; Tempo integral

Resumo da vaga

Regeneron Pharmaceuticals, Inc. seeks 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 product manufacture complies with cGMP and regulations, coordinate batch scheduling, material supply, and shipment, and advance process improvements across external manufacturing sites.

Qualificações

• 8 years of related experience in manufacturing operations.
• Minimum 5 years direct cGMP manufacturing operations experience.
• MBA preferred.

Responsabilidades

• Drive day-to-day execution across the CMO network and lead a team focused on continuous improvement and technical excellence.
• Ensure product manufacture occurs in compliance with cGMP and applicable regulations.
• Coordinate batch scheduling, material supply, direct shipment, cycle time tracking, and related reports.
• Lead timely routing/review of technical transfer activities, validation plans, MRs, SOPs, and other documentation.
• Implement site production initiatives and drive improvements to reduce cycle times and increase efficiency.
• Monitor cGMP compliance at contract manufacturers and support investigations as needed.

Conhecimentos

cGMP manufacturing

Operations management

Regulatory compliance

Leadership

Formação

BS/BA degree

MBA preferred

Descrição da vaga

Regeneron Pharmaceuticals, Inc. seeks 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 product manufacture complies with cGMP and regulations, coordinate batch scheduling, material supply, and shipment, and advance process improvements across external manufacturing sites.