CAR-T Operations Support Lead

Job Description

Legend Biotech is seeking a CAR-T Operations Support Lead to coordinate and execute support activities for the daily production of personalized cell therapies within a sterile cGMP environment in Ghent, Belgium. The role ensures compliance with cGMP regulations while optimizing operational efficiency through material transfers, cleanroom maintenance, and inventory replenishment. The Lead will collaborate with various departments and serve as the first point of contact for support operators.

Responsibilities:

• Acts as an SME for quality aspects related to support production activities.
• Manages documentation review, including SOPs and batch records.
• Conducts routine inspections of documentation and GMP housekeeping.
• Collaborates with Quality and MS&T to oversee QMS-related processes.
• Represents support production quality aspects in audits.
• Leads daily support operations, including material transfers and waste management.
• Optimizes support processes to improve efficiency.
• Oversees inventory management.
• Assigns daily tasks to support operators.
• Acts as a liaison between logistics and warehouse teams.
• Participates in continuous improvement initiatives.
• Monitors and reports on KPIs.

Requirements:

• Bachelor’s or Master’s degree in Science, Bio-Engineering, Pharmacy, or related field.
• 3-5 years of operational experience within a GMP or ATMP environment.
• At least 1 year of experience leading teams or managing projects.
• Fluent in Dutch and English.
• Strong leadership, organizational, and problem-solving skills.
• Knowledge of cGMP regulations and cleanroom behaviors.
• Proficiency in Microsoft Office tools.
• Ability to work in shifts and accommodate unplanned overtime.

What Legend Biotech offers:

• Excellent work-life balance (4 days on, 4 days off).
• Supportive and innovative work environment.
• Permanent contract.
• Attractive salary package with benefits (additional statutory vacations, meal vouchers, insurance, bonuses).
• Participation in informal events.