Senior External Manufacturing Lead, Gene Therapy

Regeneron Pharmaceuticals, Inc.; New York; Presencial; USD 140.000 - 180.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. is seeking a Principal External Manufacturing Specialist to lead day-to-day external manufacturing activities for Gene Therapy programs and to manage relationships with CMOs and partners in Drug Substance and/or Drug Product manufacturing.

The role partners with Quality Control, QA, Supply Chain, and product launch teams to ensure timely transfers, compliant documentation, and optimized cycle times while supporting regulatory filings and strategic initiatives.

Formación

• BS/BA in business or scientific discipline with 8+ years of related experience in cGMP manufacturing operations (clinical and/or commercial) 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 to collaborate with other departments and contractors.
• Ability to lead continuous improvements, system implementations and/or strategy development to reduce cycle times and improve efficiencies.

Responsabilidades

• Serving as the operational contact for contract manufacturing and/or partner sites for Drug Substance and/or Drug Product Manufacturing for Gene Therapy programs.
• Facilitating all External Manufacturing activities at contract and/or business partner sites, including scheduling batches, supply of materials, direct shipment of bulk product, tracking cycle times, and providing reports and technical expertise.
• Liaising between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics and CMOs or partners.
• Collaborating with New Product Launch Teams and Life Cycle Management Teams for efficient product launches.
• Overseeing technical transfer activities, validation plans, MR creation, SOPs and documentation for clinical and commercial external manufacturing.

Conocimientos

Contract manufacturing

Supplier management

Regulatory filing support

Cross-functional collaboration

Educación

BS/BA in business or scientific discipline

Descripción del empleo

Regeneron Pharmaceuticals, Inc. is seeking a Principal External Manufacturing Specialist to lead day-to-day external manufacturing activities for Gene Therapy programs and to manage relationships with CMOs and partners in Drug Substance and/or Drug Product manufacturing.

The role partners with Quality Control, QA, Supply Chain, and product launch teams to ensure timely transfers, compliant documentation, and optimized cycle times while supporting regulatory filings and strategic initiatives.