Senior External Manufacturing Lead – GMP & Tech Transfer

Regeneron Pharmaceuticals; Valley (AL); On-site; USD 92,000 - 151,000; Full time

Job summary

Regeneron Pharmaceuticals, East Greenbush, NY, seeks a Principal External Manufacturing Specialist to oversee contract manufacturing partners in synthetic chemistry-based oligonucleotide production. The role ensures timely operations, documentation, and cGMP compliance across sites.

You will coordinate batch scheduling, tech transfer, and continuous improvements while collaborating with QA, QC, supply chain, and vendors.

Qualifications

• BS/BA in a scientific discipline and 8+ years of cGMP manufacturing experience.
• Experience with small molecule chemistry or siRNA therapy (preferred).
• Knowledge of regulatory compliance: cGMP, FDA, ICH, EU guidelines.

Responsibilities

• Serve as operational contact for contract manufacturing and partner sites.
• Coordinate external manufacturing activities including batch scheduling, materials, and shipment direction.
• Liaise between Regeneron QC/QA, Supply Chain, Operations and CMOs.
• Lead sub-team on continuous process improvements, system implementations, and strategy development.
• Support investigations concerning external manufacturing and shipping operations.
• Support tech transfer and development work at a CMO to ensure GMP scalability.
• Review pre-production master batch records and executed batch records.

Skills

Interpersonal skills

Written communication

Oral communication

Education

BS/BA in a scientific discipline

Job description

Regeneron Pharmaceuticals, East Greenbush, NY, seeks a Principal External Manufacturing Specialist to oversee contract manufacturing partners in synthetic chemistry-based oligonucleotide production. The role ensures timely operations, documentation, and cGMP compliance across sites.

You will coordinate batch scheduling, tech transfer, and continuous improvements while collaborating with QA, QC, supply chain, and vendors.