Lead, External Manufacturing - Advanced Therapies

Regeneron; New York (NY); On-site; USD 140,000 - 230,000; Full time

Job summary

Regeneron is seeking a Principal External Manufacturing Specialist to oversee synthetic chemistry-based oligonucleotide manufacturing with external partners. You will coordinate batches, shipments and documentation, while aligning QA, Supply Chain and Operations to ensure timely and compliant manufacturing activities.

Role emphasizes leadership in process improvements, tech transfer at CMOs, and maintaining cGMP compliance across partner sites in a fast-paced environment.

Qualifications

• BS/BA in a scientific discipline is required.
• Experience in cGMP manufacturing operations is essential.
• Knowledge of regulatory requirements (FDA, cGMP, ICH) is preferred.

Responsibilities

• Serve as the operational contact for contract manufacturing sites.
• Coordinate external manufacturing activities including scheduling batches and material shipments.
• Liaise between Regeneron quality, supply chain, operations and contract manufacturers.
• Lead sub-teams in continuous process improvements and system implementations.
• Support investigations related to external manufacturing and shipping operations.
• Contribute to strategic initiatives and contract negotiations for partner relationships.
• Monitor cGMP compliance at contract manufacturers and partners.
• Support tech transfer and development work at CMOs to scale toward GMP.
• Review pre-production and executed batch records.

Skills

Contract manufacturing coordination

Cross-functional liaison

cGMP compliance knowledge

Regulatory awareness

Process improvement leadership

Education

BS/BA in a scientific discipline

Tools

Documentation systems

Quality systems

Job description

Regeneron is seeking a Principal External Manufacturing Specialist to oversee synthetic chemistry-based oligonucleotide manufacturing with external partners. You will coordinate batches, shipments and documentation, while aligning QA, Supply Chain and Operations to ensure timely and compliant manufacturing activities.

Role emphasizes leadership in process improvements, tech transfer at CMOs, and maintaining cGMP compliance across partner sites in a fast-paced environment.