CAR-T Operations Expert

Responsibilities

• Perform and oversee CAR-T process activities including component preparation, processing, filling, finishing, and cryopreservation
• Ensure all activities comply with cGMP and GDP standards and maintain GMP documentation
• Manage daily production planning and support production surveys
• Create and review operational procedures, work instructions, and master batch records
• Collaborate with teams to optimize processes and participate in Lean & Operational Excellence projects
• Train and coach junior colleagues
• Support testing and implementation of production software such as eLiMS, MES, and SAP

Requirements

• Bachelor's or Master's degree in sciences, (bio)engineering, biotechnology, pharmacy, or equivalent experience
• At least 5 years of operational experience with cell culture
• Previous experience in manufacturing, quality, or engineering
• Thorough knowledge of cGMP regulations and cell culture techniques
• Proficiency in Microsoft Office tools
• Fluency in Dutch or English

Preferred Qualifications

• Experience with cGMP systems such as PASx, eLIMs, Siemens, or SAP

Benefits

• Meaningful work contributing to patient well-being
• Excellent work-life balance (4 days on, 4 days off schedule)
• Supportive and innovative work environment
• Indefinite duration contract
• Attractive salary package with fringe benefits (meal vouchers, group and hospitalization insurance, double vacation pay, bonuses)
• Company laptop and net allowance
• Bicycle lease plan

About the Company

Legend Biotech is a global biotechnology company dedicated to developing, manufacturing, and commercializing innovative and life-saving cell therapies for the treatment of chronic and life-threatening diseases, such as cancer.