External Manufacturing Manager

3 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.
  • Ensure compliance with cGMP and applicable regulations in product manufacture.
  • Facilitate all External Manufacturing activities at contract and/or business partner manufacturing sites.
  • Schedule batches, supply materials, and direct shipment of bulk and finished product at manufacturing sites.
  • Track and supervise cycle times, providing associated reports and technical expertise.
  • Form strategic partnerships with technical and operational colleagues to collaborate with other departments and contractors.
  • Act 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.
  • Ensure timely routing and review of technical transfer activities.
  • Collaborate on validation plans, master manufacturing records, standard operating procedures, and other documentation.
  • Support critical initiatives and contract negotiations to drive long-term relationship stability and success.
  • Implement site initiatives in production operations as advised by site management.
  • Lead continuous improvements, system implementations, and strategy development.

Requirements:

  • BS/BA in business or scientific subject area.
  • 7 years of related experience in cGMP manufacturing operations, supplier management, or equivalent combination of education and experience.
  • Ability to maintain training status on Regeneron specific work instructions and SOPs.
  • Experience in providing regulatory filing support to IND, BLA, MAA, etc.

What We Offer:

  • Comprehensive benefits package.
  • Equity awards and annual bonuses.
  • Paid time off for eligible employees.

Regeneron Pharmaceuticals is an Equal Opportunity Employer.



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