Change Control Specialist

Role: Change Control Specialist supporting manufacturing operations at Regeneron, focusing on managing change control initiatives, CAPAs, and process improvements within biologics or drug substance manufacturing. Responsibilities include developing business plans, assessing complex change proposals, preparing and reviewing change documentation for compliance with cGMP, leading cross-functional meetings, and mentoring teams. Seniority levels range from Associate to Senior Specialist, based on experience (0-5+ years). Requirements: BS/BA in Life Sciences, Engineering, or related field; relevant experience aligned with role level; strong understanding of GMP standards and regulatory impacts; proficiency in documentation, risk assessment, and change management. Preferred: prior experience in biologics manufacturing, process validation, or quality systems. High-Value: biologics or small molecule manufacturing, GMP compliance, change control in cGMP environment, cross-departmental collaboration, training responsibilities. Work setup: on-site in Rensselaer, NY, Monday-Friday, with potential for mentorship and training duties.