Senior Manager, Manufacturing Operations (2nd Shift)

Role: Senior Manager of Manufacturing Operations overseeing cGMP biologics manufacturing, responsible for leading a supervisory team, ensuring compliance, safety, and efficiency. Responsibilities include managing day-to-day production activities, maintaining audit readiness, driving continuous improvement, leading interdisciplinary projects, and ensuring timely achievement of manufacturing goals. Core duties also encompass batch record review, investigations, CAPAs, validation support, and fostering cross-functional collaboration. Requirements: Bachelor's in scientific, technical, or engineering discipline; 10+ years experience in cGMP pharmaceutical manufacturing, with prior cell therapy and aseptic processing expertise. Proven leadership in managing manufacturing teams and supervisors. Skills: deep knowledge of cGMP, process validation, deviation management, and quality systems; strong interpersonal, organizational, and problem-solving capabilities; proficiency with GMP documentation platforms. Preferred: experience with POMS MES, late-stage development, and commercial manufacturing support. High-Value: biologics/cell therapy, aseptic manufacturing, cGMP compliance, validation, and cross-functional leadership. Work schedule: supporting 2nd shift, with initial training and flexible scheduling. Location: on-site at Cambridge and Leiden, with potential shift adjustments. Compensation: $139,100–$208,700 plus bonus and equity, with comprehensive benefits.