Principal External Manufacturing Specialist (Advanced Therapies)
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 Bulk External Manufacturing (Advanced Therapies) team that specializes in synthetic chemistry-based oligonucleotide manufacturing. This role oversees all aspects of contract manufacturing organizations and partners including day-to-day operations, ensuring timely completion of associated operations/documentation, and assisting in the monitoring of cGMP compliance. When & where:Location: East Greenbush, New York, United StatesWork model: Monday-Friday, 8am-4:30pmTravel: up to 25%Discover your role:Serve as the operational contact for contract manufacturing and/or partner sites concerning day-to-day activitiesCoordination of external manufacturing activities at contract and/or business partner sites, including but not limited to scheduling of all batches, supply of materials, providing direction on shipment of material, tracking and monitoring of cycle times, providing supporting documentation for manufacturing activities and enlisting support from others who will provide any required associated reports and technical expertiseFunctioning as a liaison between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partnersLeads a sub-team in continuous process improvements, system/equipment implementation and/or strategy developmentSupporting investigations which concern external manufacturing and associated shipping operations, as requiredSupporting and informing strategic initiatives and contract negotiations that drive long-term relationship stability and successEnsuring product integrity and company reputation by assisting in the monitoring of cGMP compliance at contract manufacturers and business partnersSupport tech transfer and/or development work of programs at a CMO to ensure scalability toward GMP manufacturingPerforming reviews of pre-production master batch records and executed batch recordsThis role requires:BS/BA in a scientific discipline and 8+ year of experience in cGMP manufacturing operations, or equivalent combination of education and experienceExperience in any of the following areas (recommended): small molecule synthetic chemistry and/or siRNA therapyKnowledge of bulk manufacturing techniques (recommended) – chemical synthesis, downstream purification, annealing, lyophilizationBasic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines, and EU regulationsAbility to lead continuous improvements, system implementations and/or strategy development to reduce cycle times and improve efficiencies for areaStrong interpersonal, written, and oral communication skillsDoes this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to...