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Associate Manager External Manufacturing - Bulk/API

Company: Regeneron Pharmaceuticals, Inc.
Location: Troy
Posted on: January 10, 2022

Job Description:

We are currently looking to fill an Associate Manager position within the Bulk External Manufacturing (DS/FDS/API) team. 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 Associate Manager External Manufacturing is to act as the Relationship Lead with the CMO/Partners or as the Operations Lead within the External Manufacturing Teams.As an Associate Manager of External Manufacturing (DS/FDS/API), a typical day might include the following: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 and finished 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 (recommended): gene therapy, cell therapy, siRNA therapy, antibody drug conjugates, small molecule synthetic chemistry, plasmid manufacturingYou 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 processesCan travel to contract manufacturers or business partners, as required (10-25%).May manage direct reports and/or lead a sub-team in continuous process improvements, system/equipment implementation and/or strategy development.To be considered for the Associate Manager of External Manufacturing, a BS/BA in business or scientific discipline and 6 years of related experience in either cGMP manufacturing operations (clinical and/or commercial) or supplier management or equivalent combination of education and experience.Does this sound like you?-- - Apply now to take your first steps toward living the Regeneron Way!-- - We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.-- - We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process.-- - Please contact us to discuss any accommodations you think you may need.

Keywords: Regeneron Pharmaceuticals, Inc., Troy , Associate Manager External Manufacturing - Bulk/API, Executive , Troy, New York

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