Principal External Manufacturing Specialist (LNP, Peptide)

Regeneron is currently looking for a Principal External Manufacturing (EM) Specialist to join the Advanced Therapies External Manufacturing Team that specializes in peptide or lipid nanoparticle manufacturing. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. This role strategically manages Regeneron’s business relationships and/or facilitates day-to-day operations with Contract Manufacturing Organizations (CMOs) and Partners. Through the External Manufacturing Team, they work to achieve a consistently high level of interaction in order to meet or exceed Regeneron’s business needs relating to product quality, availability, and delivery. They ensure that all critical external manufacturing requirements are executed to ensure world-class performance of Industrial Operations & Product Supply (IOPS) product supply chains. The role of the Principal Specialist External Manufacturing is to act as the Relationship Lead with the CMO/Partners or as the Operations Lead within the External Manufacturing Teams.

As a Principal External Manufacturing Specialist, a typical day might include the following:

• Serving as the operational contact for contract manufacturing and/or partner sites concerning day-to-day activities for sites producing oligonucleotide-related products.
• Coordination of external manufacturing activities at contract and/or business partner Ensuring that product manufacture occurs in compliance with cGMP and applicable regulations.
• Facilitating all External Manufacturing activities at contract and/or business partner manufacturing sites, including but not limited to: 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.
• Implementing site initiatives in production operation as directed by site management.
• 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, as required.
• The Relationship Leads have overall responsibility for RFPs, project plans, purchase requisitions, etc. associated with contractor operations.
• Providing regulatory filing support to IND, IMPD, BLA, MAA, etc.
• Assisting in developing metrics to analyze department activities, workload and performance.
• Maintaining required training status on Regeneron specific work instructions and SOPs.
• Serving as the primary Regeneron technical contact for select contract manufacturing sites concerning day-to-day activities.

This role might be for you if:

• You have experience in any of the following areas: peptide or lipid nanoparticle manufacturing
• You enjoy forming strategic partnerships with technical and operational colleagues to effectively collaborate with other departments and contractors.
• You lead continuous improvements, system implementations and/or strategy development to reduce cycle times and improve efficiencies for area.
• You are comfortable with ambiguity and building business processes
• Can travel to contract manufacturers or business partners, as required (10-25%).
• May manage direct reports and/or lead a sub-team in continuous process improveme