Senior External Manufacturing Lead, Gene Therapy

Regeneron Pharmaceuticals, Inc.; Rensselaer (IN); On-site; USD 94,000 - 154,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Principal External Manufacturing Specialist to lead external manufacturing activities for Gene Therapy programs, coordinating with CMOs on Drug Substance and Drug Product manufacturing.

The role drives batch scheduling, material supply, and regulatory support, acting as a key bridge among Quality, Supply Chain, and Manufacturing teams. The ideal candidate has 8+ years in cGMP operations or supplier management, strong partnerships, and a track record of

Qualifications

• BS/BA in business or scientific discipline with 8+ years of related experience.
• Experience in cGMP manufacturing operations and/or supplier management.
• Ability to form strategic partnerships and drive improvements.

Responsibilities

• Serve as operational contact for contract manufacturing and partner sites for Drug Substance/Product manufacturing in Gene Therapy programs.
• Facilitate external manufacturing activities including batch scheduling, material supply, and reporting.
• Act as liaison among Regeneron QC/QA, Supply Chain, Operations and CMOs.
• Collaborate with launch and lifecycle teams for efficient product introductions and updates.
• Oversee technical transfer activities, validation plans, MR/SOP documentation at contractors.
• Support strategic initiatives and negotiations to strengthen external manufacturing relationships.
• Lead quarterly governance meetings with CMOs to improve joint performance.
• Resolve supply issues with CMOs, evaluating cost/benefit and coordinating resources.
• Ensure on-site inspections, testing, and shipping comply with guidelines and cgMP.
• Support regulatory filings (IND/IMPD/BLAs/MAA) and monitor cGMP compliance.

Skills

Contract Manufacturing

Supplier management

Cross-functional collaboration

Project management

Education

BS/BA in business or scientific discipline

Job description

Regeneron Pharmaceuticals, Inc. seeks a Principal External Manufacturing Specialist to lead external manufacturing activities for Gene Therapy programs, coordinating with CMOs on Drug Substance and Drug Product manufacturing.

The role drives batch scheduling, material supply, and regulatory support, acting as a key bridge among Quality, Supply Chain, and Manufacturing teams. The ideal candidate has 8+ years in cGMP operations or supplier management, strong partnerships, and a track record of