Principal External Manufacturing Specialist (Advanced Therapies)

Role: Principal External Manufacturing Specialist overseeing synthetic chemistry-based oligonucleotide manufacturing within Regeneron's Advanced Therapies team. Objectives include managing external contract manufacturing operations, ensuring cGMP compliance, and supporting process improvements. Responsibilities: serve as operational liaison with CMOs and partners, coordinate batch scheduling, supply chain, and documentation; support investigations related to manufacturing/shipping; assist in tech transfer and scale-up activities; review manufacturing records; lead continuous process improvement initiatives and strategic contract negotiations. Requirements: BS/BA in a scientific discipline with 8+ years in cGMP manufacturing, preferably in small molecule synthesis or siRNA therapies; knowledge of bulk manufacturing processes such as chemical synthesis, purification, lyophilization; understanding of FDA, ICH, and EU regulations; strong communication and leadership skills. HighValue: expertise in synthetic chemistry, oligonucleotide manufacturing, cGMP compliance, regulatory knowledge, and process improvement. WorkSetup: on-site in East Greenbush, NY, with up to 25% travel.