Principal External Manufacturing Specialist (Advanced Therapies)

About the role

We are seeking a Principal External Manufacturing Specialist to oversee all aspects of contract manufacturing organizations and partners for Regeneron’s Bulk External Manufacturing (Advanced Therapies) team, with a focus on synthetic chemistry-based oligonucleotide manufacturing. This role ensures timely completion of operations and documentation, and assists in monitoring cGMP compliance.

Responsibilities

• Serve as the operational contact for contract manufacturing and/or partner sites on day-to-day activities
• Coordinate external manufacturing activities including batch scheduling, material supply, shipment direction, cycle-time tracking, and supporting documentation
• Act as a liaison between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and external manufacturers or business partners
• Lead a sub-team in continuous process improvements, system/equipment implementation, and/or strategy development
• Support investigations related to external manufacturing and shipping operations
• Support strategic initiatives and contract negotiations to drive long-term relationship stability and success
• Ensure product integrity and company reputation by assisting in the monitoring of cGMP compliance at contract manufacturers and business partners
• Support tech transfer and/or development work at a CMO to ensure scalability toward GMP manufacturing
• Perform reviews of pre-production master batch records and executed batch records

Requirements

• BS/BA in a scientific discipline and 8+ years of experience in cGMP manufacturing operations, or equivalent combination of education and experience
• Experience in small molecule synthetic chemistry and/or siRNA therapy (recommended)
• Knowledge of bulk manufacturing techniques such as chemical synthesis, downstream purification, annealing, and lyophilization (recommended)
• Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, ICH guidelines, and EU regulations
• Ability to lead continuous improvements, system implementations, and/or strategy development to reduce cycle times and improve efficiencies
• Strong interpersonal, written, and oral communication skills

Location: East Greenbush, New York, United States Work model: Monday–Friday, 8:00 am–4:30 pm Travel: up to 25%