Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking to fill a Principal External Manufacturing Specialist position within the Advanced Therapies Team that specializes in Gene Therapy (Viral Vector, LNP, Plasmid, CAR-T) Drug Substance and/or Drug Product Manufacturing.
Salary Range (annually) $94,000.00 - $153,600.00
- Serving as the operational contact for contract manufacturing and/or partner sites concerning day-to-day activities for sites contributing to Drug Substance and/or Drug Product Manufacturing for Gene Therapy programs.
- Facilitating all External Manufacturing activities at contract and/or business partner manufacturing sites, including scheduling batches, supply of materials, direct shipment of bulk 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.
