Manager,DeviceDevelopment&SecondaryPackaging

Regeneron is seeking a Manager, Combination Product Development, to join our Process Sciences—Drug Product Engineering team. In this role, you will lead the device product development group with a focus on secondary packaging, driving the development and advancement of drug delivery devices that address emerging needs across Regeneron’s product pipeline. As a Manager, Combination Product Development a typical day might include the following: * Own technical performance for a team delivering off the shelf and custom secondary packaging solutions for regulatory and commercial needs. * Ensure technically robust packaging via engineering analyses, reliability, and performance assessments. * Define design inputs and rationales; translate requirements into clear technical specifications. * Collaborate with suppliers to develop and qualify _packaging_ design outputs. * Oversee product characterization and Design Verification testing _connected to packaging_. * Author protocols and technical reports to support development milestones. * Define essential performance requirements and traceability to design outputs. * Establish development control strategies, including statistically based, risk driven sampling plans. * Support regulatory filings (IND, BLA, MAA) for drug products. * Lead and develop a cross functional engineering team; recruit, coach, and grow talent. * Manage multiple projects to deliver on time, in scope, and within budget. * Partner with peer managers to ensure program success; escalate and resolve technical risks quickly. * Build strong interfaces with internal design, QA, external manufacturing, and broader engineering teams. * Champion design controls and technical excellence across IOPS. * Build organizational standards and systems to scale development for a growing product portfolio. * Define and integrate standard design and development procedures with Regeneron business and quality systems. * Identify and implement improvements to streamline device pro