Gene Therapy External Manufacturing Lead

Regeneron Pharmaceuticals, Inc (USA); City of Rensselaer (NY); On-site; USD 94,000 - 154,000; Full time

Benefits offered by this job

Competitive total rewards package

On-site role

Travel up to 25%

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Principal External Manufacturing Specialist within the Advanced Therapies Team, focusing on Gene Therapy Drug Substance and Drug Product manufacturing at partner sites.

The role coordinates day-to-day activities with CMOs, drives continuous improvement, and supports regulatory filings to ensure product quality, availability, and successful launches across programs.

Location: East Greenbush, NY; travel up to 25%; standard hours, on-site work.

Qualifications

• BS/BA in business or scientific discipline with 8+ years in cGMP manufacturing operations or supplier management.
• Experience in Plasmid, Viral Vector, LNP, CAR-T Drug Substance and/or Drug Product is strongly preferred.
• Ability to form strategic partnerships with technical and operational colleagues across departments and contractors.

Responsibilities

• Serve as the operational contact for contract manufacturing/partner sites for Gene Therapy Drug Substance and Drug Product manufacturing.
• Facilitate external manufacturing activities: scheduling batches, material supply, shipments, and reporting.
• Act as liaison between Regeneron Quality, Supply Chain, Operations and CMOs/partners.

Skills

Strategic partnerships

Cross-functional collaboration

Project management

Regulatory & quality awareness

Education

BS/BA in business or scientific discipline

Tools

Quality management systems

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Principal External Manufacturing Specialist within the Advanced Therapies Team, focusing on Gene Therapy Drug Substance and Drug Product manufacturing at partner sites.

The role coordinates day-to-day activities with CMOs, drives continuous improvement, and supports regulatory filings to ensure product quality, availability, and successful launches across programs.

Location: East Greenbush, NY; travel up to 25%; standard hours, on-site work.