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Staff External Manufacturing Specialist

Regeneron · Rensselaer, New York, US

We are currently looking to fill a Staff External Manufacturing Specialist position within the Advanced Therapies External Manufacturing Team. Regeneron succ...

Job description

We are currently looking to fill a Staff External Manufacturing Specialist position within the Advanced Therapies External Manufacturing Team. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. This role strategically manages Regeneron’s business relationships and supports end-to-end operations oversight with key Contract Manufacturing Organizations (CMOs) within Regeneron’s Bioconjugation portfolio. As a Staff Specialist of External Manufacturing, a typical day might include the following: Lead Quarterly Business Reviews and other governance touchpoints with CMOs to drive performance, transparency, and continuous improvement. Lead RFP, SOWs, project plans, and change order management associated with contractor operations. Support and inform strategic initiatives and contract negotiations that drive long-term relationship stability and supply security. Provide regulatory filing support across global clinical and/or commercial submissions as it pertains to CMO activities. Lead external manufacturing activities at CMO and partner sites, including batch scheduling...