Associate / Manager External Manufacturing

3 weeks ago

Tarrytown, United States Regeneron Pharmaceuticals, Inc Full time

Within this role you will strategically manage business relationships and facilitate day-to-day operations with Contract Manufacturing Organizations (CMOs) and Partners through the Drug Product (DP) Manufacturing Team to achieve a consistently high level of interaction in order to meet or exceed Regeneron’s business needs. Ensures that all critical external manufacturing requirements are driven to ensure world-class performance of product supply chains. The role of the Manager External Manufacturing is to act as the Relationship and Operations Lead with the CMOs/Partners.

As a Manager for External Manufacturing, a typical day might include, but is not limited to, the following:

Manages activities at contract and/or business partner manufacturing sites, including scheduling batches, supply of materials, direct shipment of bulk and finished product at manufacturing site, tracking and supervising cycle times and providing any required associated reports and technical expertise

Leads operations for new technologies and new product development

Collaborates with Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners

Collaborates with New Product Launch Teams and Life Cycle Management Teams for efficient product launches of Regeneron’s medicines

Ensures, in collaboration with the 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 complete required clinical and commercial external manufacturing activities

Supports and informs critical initiatives and contract negotiations that drive long-term relationship stability and success

Runs quarterly business review meetings or other governance structures with CMOs to drive continuous improvement and implement efficiencies

Resolves all supply issues that affect product quality or availability, including evaluating cost/benefit scenarios, making sound recommendations and coordinating internal and external resources to address issues

Ensures product integrity and company reputation by assisting in the monitoring of cGMP compliance and supporting investigations

Develops metrics to analyze department activities, workload and performance

May manage direct report and/or lead a sub-team in continuous process improvements, system/equipment implementation and/or strategy development

Travel (25-50%)

This role might be for you if:

You have strong interpersonal skills and can effectively communicate with peers and superiors

You are action-orientated and decisive

You demonstrate an ability to effectively manage projects

You can present in a direct and informative manner

You have a proven track record working as part of a successful team

To be considered for this opportunity you should have a BS/BA in a business or scientific discipline and 6-7 years of related experience in either cGMP manufacturing operations (clinical and/or commercial) or supplier management or equivalent combination of education and experience.

Relevant experience may be substituted in lieu of the educational requirement.

#LI-Onsite #IRELIM #JOBSIEST

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