About the role

An 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