External Manufacturing Manager

4 weeks ago

East Greenbush, New York, United States Regeneron Pharmaceuticals Full time

Job Summary

We are seeking a highly skilled External Manufacturing Manager to join our team at Regeneron Pharmaceuticals. As a key member of our External Manufacturing Team, you will be responsible for leading business relationships and facilitating day-to-day operations with Contract Manufacturing Organizations (CMOs) and Partners.

Key Responsibilities

  • Strategically lead business relationships with CMOs and Partners to meet or exceed Regeneron's business needs relating to product quality, availability, and delivery.
  • Ensure that all critical external manufacturing requirements are implemented to ensure world-class performance of Industrial Operations & Product Supply (IOPS) product supply chains.
  • Act as the Relationship Lead with the CMO/Partners or as the Operations Lead within the External Manufacturing Teams.
  • Ensure that product manufacture occurs in compliance with cGMP and applicable regulations.
  • Facilitate all External Manufacturing activities at contract and/or business partner manufacturing sites.
  • Schedule all batches, supply materials, direct shipment of bulk and finished product at manufacturing site.
  • Form strategic partnerships with technical and operational colleagues to optimally collaborate with other departments and contractors.
  • Function as a liaison between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners.
  • Collaborate with New Product Launch Teams and Life Cycle Management Teams for efficient product launches of Regeneron's medicines.
  • Ensure, in collaboration with the External Manufacturing Project Management team, the timely routing and review of all technical transfer activities.
  • Collaborate on validation plans, master manufacturing records (MRs), standard operating procedures (SOPs) and other documentation needed to successfully implement required clinical and commercial external manufacturing activities at contractors and/or business partners.
  • Support and advise critical initiatives and contract negotiations that drive long-term relationship stability and success.
  • Implement site initiatives in production operation as advised by site management.
  • Lead continuous improvements, system implementations, and/or strategy development.
  • Resolve all supply issues with the CMO/Partner that affect product quality or availability, including evaluating cost/benefit scenarios and making sound recommendations.
  • Ensure off-site inspections, testing, and shipping/packaging is done according to guidelines and specifications.
  • Support investigations which concern External Manufacturing or associated shipping operations when needed.
  • May serve as the primary Regeneron technical contact for select contract manufacturing sites concerning day-to-day activities.
  • Wish to manage direct reports and/or lead a sub-team in continuous improvements, system/equipment implementation, and/or strategy development.
  • Enjoy being the relationship lead and have overall responsibility for RFP's, project plans, purchase requisitions, etc. associated with contractor operations.
  • Able to maintain training status on Regeneron specific work instructions and SOP's.
  • Have experience in providing regulatory filing support to IND, BLA, MAA, etc.

Requirements

  • BS/BA in business or scientific subject area.
  • 7 years of related experience in either cGMP manufacturing operations (clinical and/or commercial) or supplier management or equivalent combination of education and experience.

Regeneron Pharmaceuticals is an equal opportunity employer

We are committed to diversity and inclusion. We are 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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.

We will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

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