Principal External Manufacturing Specialist (Oligonucleotides)

Role Summary

Principal External Manufacturing Specialist (Oligonucleotides) role overseeing all aspects of contract manufacturing organizations and partners, ensuring day-to-day operations, timely completion of operations/documentation, and monitoring cGMP compliance within the Advanced Therapies External Manufacturing Team.

Responsibilities

• Serving as the operational contact for contract manufacturing and/or partner sites concerning day-to-day activities.
• Coordinate external manufacturing activities at contract and/or business partner sites, including scheduling of batches, supply of materials, directing shipment of material, tracking cycle times, providing supporting documentation for manufacturing activities, and coordinating with teams for required reports and technical expertise.
• Function as a liaison between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics, and contract 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 associated shipping operations.
• Support and inform strategic initiatives and contract negotiations that drive long-term relationship stability and success.
• Assist in monitoring cGMP compliance at contract manufacturers and business partners to ensure product integrity and company reputation.
• Support tech transfer and/or development work of programs at a CMO to ensure scalability toward GMP manufacturing.
• Review pre-production master batch records and executed batch records.

Qualifications

• Experience in small molecule synthetic chemistry and/or siRNA therapy (or equivalent).
• Knowledge of bulk manufacturing techniques (recommended) – chemical synthesis, downstream purification, annealing, lyophilization.
• Basic knowledge of regulatory compliance including cGMP, FDA regulations, ICH guidelines, and EU regulations.
• Experience leading continuous improvements, system implementations and/or strategy development to reduce cycle times and improve efficiencies.
• Strong interpersonal, written, and oral communication skills.
• Ingenuity, creativity, and resourcefulness in evolving and ambiguous environments.
• Ability to understand provided instructions and work toward goals with minimal supervision.
• Willingness to travel to contract manufacturers or business partners (up to 25%).
• Experience leading a sub-team in continuous process improvements, system/equipment implementation and/or strategy development.
• Resiliency and flexibility in the face of challenges and adverse situations.

Education

• BS/BA in business or scientific discipline; 8+ years of related experience, or equivalent combination of education and experience.
• cGMP experience is preferred in manufacturing operations (clinical and/or commercial) or supplier management.