Manager External Bulk Manufacturing

Regeneron Pharmaceuticals•Rensselaer, IN

About The Position

We are currently looking to fill a Mgr External Bulk Manufacturing position. The Mgr External Bulk Manufacturing strategically manages business relationships and/or facilitates day-to-day operations with Contract Manufacturing Organizations (CMOs) and Partners 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. Ensures that all critical external bulk manufacturing requirements are executed to ensure world-class performance of Industrial Operations & Product Supply (IOPS) product supply chains. The role of the Manager External Bulk Manufacturing is to act as the Relationship Lead with the CMO/Partners. In this role, a typical day might include the following: Ensures that product manufacture occurs in compliance with cGMP and applicable regulations. Facilitates all External Bulk Manufacturing activities at contract and/or business partner manufacturing sites, including but not limited to scheduling of all batches, supply of materials, direct shipment of bulk and finished product at manufacturing site, tracking and monitoring cycle times and providing any required associated reports and technical expertise. Forms strategic partnerships with technical and operational colleagues to effectively collaborate with other departments and contractors. Functions as a liaison between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners. Ensures the timely routine 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. Supports and informs strategic initiatives and contract negotiations that drive long-term relationship stability and success. Implements site initiatives in production operation as directed by site management. Leads continuous improvements, system implementations and/or strategy development to reduce cycle times and improve efficiency for area. The Relationship Leads manage quarterly business review meetings or other governance structures with CMOs to drive continuous improvement in joint performance. Resolves 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. Ensures off-site inspections, testing and shipping/packaging is done according to guidelines and specifications. Ensures product integrity and company reputation by assisting in the monitoring of cGMP compliance at contract manufacturers. Supports 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. Provides regulatory filing support to IND, BLA, MAA, etc. Assists in developing metrics to analyze department activities, workload and performance. Maintains required training status on Regeneron specific work instructions and SOPs. May manage direct report and/or lead a sub-team in continuous process improvements, system/equipment implementation and/or strategy development. May serve as the primary Regeneron technical contact for select contract manufacturing sites concerning day-to-day activities. Travels to contract manufacturers or business partners, as required (25-50%).

Requirements

To be considered for the Manager you must have a BS/BA in business or scientific discipline and 7 years of related experience in either cGMP manufacturing operations (clinical and/or commercial) or supplier management or equivalent combination of education and experience.

Responsibilities

Ensures that product manufacture occurs in compliance with cGMP and applicable regulations.
Facilitates all External Bulk Manufacturing activities at contract and/or business partner manufacturing sites, including but not limited to scheduling of all batches, supply of materials, direct shipment of bulk and finished product at manufacturing site, tracking and monitoring cycle times and providing any required associated reports and technical expertise.
Forms strategic partnerships with technical and operational colleagues to effectively collaborate with other departments and contractors.
Functions as a liaison between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners.
Ensures the timely routine 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.
Supports and informs strategic initiatives and contract negotiations that drive long-term relationship stability and success.
Implements site initiatives in production operation as directed by site management.
Leads continuous improvements, system implementations and/or strategy development to reduce cycle times and improve efficiency for area.
The Relationship Leads manage quarterly business review meetings or other governance structures with CMOs to drive continuous improvement in joint performance.
Resolves 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.
Ensures off-site inspections, testing and shipping/packaging is done according to guidelines and specifications.
Ensures product integrity and company reputation by assisting in the monitoring of cGMP compliance at contract manufacturers.
Supports 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.
Provides regulatory filing support to IND, BLA, MAA, etc.
Assists in developing metrics to analyze department activities, workload and performance.
Maintains required training status on Regeneron specific work instructions and SOPs.
May manage direct report and/or lead a sub-team in continuous process improvements, system/equipment implementation and/or strategy development.
May serve as the primary Regeneron technical contact for select contract manufacturing sites concerning day-to-day activities.
Travels to contract manufacturers or business partners, as required (25-50%).

Benefits

We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!
For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.
For other countries’ specific benefits, please speak to your recruiter.

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