Principal External Manufacturing Specialist, Gene Therapy

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• Serving as the operational contact for contract manufacturing and/or partner sites concerning day-to-day activities for sites contributing to Drug Substance and/or Drug Product Manufacturing for Gene Therapy programs.
• Facilitating all External Manufacturing activities at contract and/or business partner manufacturing sites, including scheduling batches, supply of materials, direct shipment of bulk product at manufacturing site, tracking and monitoring cycle times and providing any required associated reports and technical expertise.
• Functioning as a liaison between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners.
• Collaborating with New Product Launch Teams and Life Cycle Management Teams for efficient product launches of Regeneron's medicines.
• Ensuring, in collaboration with the External Manufacturing Project Management team, the timely routing and review of all technical transfer activities, validation plans, master manufacturing records (MRs), standard operating procedures (SOPs) and other documentation needed to successfully execute required clinical and commercial external manufacturing activities at contractors and/or business partners.
• Supporting and informing strategic initiatives and contract negotiations that drive long-term relationship stability and success.
• Managing quarterly business review meetings or other governance structures with CMOs to drive continuous improvement in joint performance.
• Resolving all supply issues with the CMO/Partner that affect product quality or availability, including evaluating cost/benefit scenarios, making sound recommendations and coordinating internal and external resources to address issues.
• Ensuring off-site inspections, testing and shipping/packaging is done according to guidelines and specifications.
• Ensuring product integrity and company reputation by assisting in the monitoring of cGMP compliance at contract manufacturers.
• Supporting investigations which concern External Manufacturing or associated shipping operations.
• Providing regulatory filing support to IND, IMPD, BLA, MAA, etc.
• Assisting in developing metrics to analyze department activities, workload and performance.
• Serving as the primary Regeneron technical contact for select contract manufacturing sites concerning day-to-day activities.

This role requires

• BS/BA in business or scientific discipline and 8+ years of related experience in either cGMP manufacturing operations (clinical and/or commercial) or supplier management, or equivalent combination of education and experience.
• Experience in any of the following areas (strongly preferred): Plasmid, Viral Vector, LNP, CAR-T Drug Substance and/or Drug Product Experience.
• Ability to form strategic partnerships with technical and operational colleagues to effectively collaborate with other departments and contractors.
• Ability to lead continuous improvements, system implementations and/or strategy development to reduce cycle times and improve efficiencies for area.