Principal External Manufacturing Specialist (LNP, Peptide)

Role Summary

Principal External Manufacturing Specialist (LNP, Peptide) to join the Advanced Therapies External Manufacturing Team, focusing on peptide or lipid nanoparticle manufacturing. Manages relationships with CMOs/Partners and facilitates day-to-day external manufacturing activities to meet product quality, availability, and delivery needs. Ensures external manufacturing requirements support world-class performance of IOPS product supply chains and serves as Relationship Lead with CMOs or Operations Lead within External Manufacturing Teams.

Responsibilities

• Serve as the operational contact for contract manufacturing and/or partner sites for day-to-day activities for sites producing oligonucleotide-related products.
• Coordinate external manufacturing activities at contract and/or business partner sites, ensuring product manufacture complies with cGMP and applicable regulations.
• Facilitate external manufacturing activities at contract/manufacturer sites, including scheduling batches, material supply, direct shipment of bulk product, tracking cycle times, and providing required reports and technical expertise.
• Act as a liaison between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics, and contract manufacturers or partners.
• Collaborate with New Product Launch Teams and Life Cycle Management Teams for efficient product launches.
• Ensure timely routing and review of technical transfer activities, validation plans, MR/SOPs, and other documentation needed for clinical and commercial external manufacturing at contractors/partners.
• Support strategic initiatives and contract negotiations to drive long-term relationship stability and success.
• Implement site initiatives in production operations as directed by site management.
• Manage quarterly business reviews or other governance structures with CMOs to drive continuous improvement.
• Resolve supply issues with CMOs/Partners affecting product quality or availability; evaluate cost/benefit scenarios and coordinate resources to address issues.
• Ensure off-site inspections, testing, and shipping/packaging meet guidelines and specifications.
• Monitor cGMP compliance at contract manufacturers to protect product integrity and company reputation.
• Support investigations related to External Manufacturing or shipping operations as required.
• Oversee RFPs, project plans, purchase requisitions, and related contractor operations.
• Provide regulatory filing support to IND, IMPD, BLA, MAA, etc.
• Develop metrics to analyze department activities, workload, and performance.
• Maintain training status on Regeneron-specific work instructions and SOPs.
• Serve as the primary Regeneron technical contact for select contract manufacturing sites for day-to-day activities.

Qualifications

• Required: BS/BA in business or scientific discipline and 8+ years of related experience, or equivalent combination of education and experience. Willingness to travel as needed.
• Preferred: cGMP experience in manufacturing operations (clinical and/or commercial) or supplier management.
• Experience in peptide or lipid nanoparticle manufacturing is highly desirable.
• Ability to work Monday‚ÄìFriday, 8am‚Äì4:30pm (travel optional).

Skills

• Relationship management with CMOs/partners
• Project management and regulatory filing support
• cGMP compliance and quality systems knowledge
• Cross-functional collaboration and communication
• Process improvement and strategic planning

Education

• BS/BA in business or scientific discipline (required)

Additional Requirements

• Willingness to travel (10‚Äì25%) for contract manufacturers or business partners