About the roleAn Operations Advanced Support Supervisor will oversee the support operations team responsible for production support activities, including Grade B cleaning, Material Transfer, Replenishment and Sterilization.The role involves managing aspects of the CAR-T process operations, ensuring safe and compliant manufacturing operations in line with cGMP requirements. The position operates on a 4/4 shift system with 10-hour shifts.Key responsibilities
Act as a SME for quality aspects related to production activities
Manage and review documentation in Production zones, including batch records and SOPs
Lead and coordinate production support activities, optimizing schedules for compliance
Support Tech Transfer plans for new production introductions and process optimizations
Implement and lead Tier 1 and Tier 2 meetings to ensure clear communication
Ensure safe and compliant operations according to EHS and cGMP
About you
Bachelor or Master in science, bio-engineering, pharmacy or related field
Min of 1 year in a cGMP or ATMP environment
Min of 5 years of direct people management, overseeing teams of 10+ individuals
Proficiency with Microsoft Office tools, MES/EBR knowledge is a plus
Fluency in English and Dutch
Ability to accommodate shift work, including evenings and weekends as required
