Senior Manager, Manufacturing Operations (3rd Shift)

Role: Senior Manager of Manufacturing Operations overseeing cGMP biologics manufacturing, with a focus on cell therapy production. Objectives include ensuring safe, compliant, and efficient operations aligned with production schedules and site goals. Responsibilities encompass managing and developing a supervisory team, leading interdisciplinary projects, overseeing batch documentation and GMP compliance, and driving continuous improvements in manufacturing practices. The position involves real-time oversight of equipment, validation activities, investigations, and maintaining audit readiness. Collaboration spans cross-functional teams, with a focus on operational performance, safety, quality, and regulatory adherence. Requirements: Bachelor's in a scientific, technical, or engineering discipline; 10+ years of experience in pharmaceutical manufacturing, including leadership of teams and supervision of cell therapy operations; deep knowledge of cGMP, validation, and aseptic manufacturing; proficiency with GMP documentation systems like QDoCCS. Preferred: experience supporting commercial or late-stage development, POMS MES systems, and knowledge of Process by Design (QbD) and statistical analysis. The role supports overnight shifts, with a 90-day onboarding training period, based in Cambridge or Leiden, with potential schedule adjustments. High-Value: biologics, cell therapy, cGMP manufacturing, validation, and regulatory compliance in a highly regulated environment.