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 an External Manufacturing Specialist position within the Advanced Therapies team that specializes in synthetic or fermentation-based processes. This role coordinates 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 YorkWork schedule: Monday-Friday, 8am-4:30pmTravel: 25%Discover your role:Serving 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 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 partnersSupporting investigations and associated shipping operationsSupporting and advising critical initiatives and contracts 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 partners.Support 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 scientific field and the following amount of related experience in cGMP manufacturing operations (clinical and/or commercial), or equivalent combination of education and experience, for each level:Associate Specialist – 0-2 yearsSpecialist – 2+ yearsLevel will be determined based on experienceYou have experience in any of the following areas: synthetic-based processes, small molecule synthesis, antibody drug conjugates, fermentationYou have knowledge of bulk manufacturing techniques (recommended) – fermentation, chemical synthesis, downstream purification, conjugation and/or formulationYou have basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines, and EU regulationsYou have strong interpersonal, written, and oral communication skillsYou can gain understanding from the instructions provided and work towards goals with minimal supervisionShows resiliency and flexibility in the face of a dynamic environmentDoes this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive cult...