Principal External Manufacturing Lead - Drug Product

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 79,000 - 151,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in East Greenbush, NY seeks External Manufacturing Specialists at Senior/Principal level to oversee contract manufacturing operations for filling, assembly and packaging. The role provides guidance, ensures cGMP compliance, and coordinates across multiple sites and partners.

The position requires a BS/BA in a scientific discipline and 5+ to 8+ years of cGMP experience, with travel up to 25%. Working hours are Mon-Fri, 8am-4:30pm.

Qualifications

• BS/BA in a scientific discipline; experience in cGMP manufacturing operations.
• 5+ years for Senior Specialist; 8+ years for Principal Specialist.
• Experience collaborating with CMOs/CROs.
• Knowledge of regulatory compliance incl. cGMP, FDA, ICH and EU regs.

Responsibilities

• Coordinate external manufacturing activities at contract and partner sites.
• Schedule batches, ensure material supply and correct shipment of bulk/finished products.
• Liaise with QA, Regulatory, Supply Chain, and other teams.
• Support audits, investigations and documentation improvements.

Skills

Interpersonal communication

Written communication

Oral communication

Education

BS/BA in a scientific discipline

Tools

Excel

PowerPoint

Visio

Word

Oracle

Job description

Regeneron Pharmaceuticals, Inc. in East Greenbush, NY seeks External Manufacturing Specialists at Senior/Principal level to oversee contract manufacturing operations for filling, assembly and packaging. The role provides guidance, ensures cGMP compliance, and coordinates across multiple sites and partners.

The position requires a BS/BA in a scientific discipline and 5+ to 8+ years of cGMP experience, with travel up to 25%. Working hours are Mon-Fri, 8am-4:30pm.