External Manufacturing Manager
3 weeks ago
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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