Are you ready to play a key role in the manufacturing of cutting-edge CAR-T cell therapies?
What can you expect?
As QC Lead you will coordinate and support in-process quality control (QC) testing, environmental monitoring (EM), and internal sample transport in a GMP-controlled cleanroom and lab environment. Your work will directly contribute to the production of lifesaving, personalized treatments for patients across the globe.
Here's what you'll do:
- Coordinate QC in-process testing (IPL) in a GMP Lab and environmental monitoring (EM) in a cGMP cleanroom.
- Act as first-line support for technical lab issues and escalate when needed.
- Troubleshoot analytical methods and lab instrumentation using quality systems.
- Lead daily Tier 1 meetings to align the team and escalate issues.
- Ensure timely execution of QC tasks, even during ad hoc planning changes or shift work.
- Use digital systems (e.g., eLIMS, MES) to document analyses and equipment status and track samples..
- Create, review, and improve QC documentation (SOPs, job aids, logbooks).
- Initiate and support investigations andCAPAs, and audit readiness.
- Drive continuous improvement and lead small optimization projects.
- Collaborate cross-functionally with QA, Manufacturing, and Process Development.
Who are we looking for?
Education:
- A minimum of a bachelor’s degree in science, Engineering, or an equivalent technical discipline.
Experience:
- Minimum 2 years of relevant work experience within the pharmaceutical or biotech industry.
- Experience in a Quality Control (QC) and with aseptic processing in ISO 5 clean rooms and biosafety cabinets.
- Familiarity with CAR-T QC test methods and related equipment.
Languages:
- Proficient in Dutch and/or English (written and oral).
Strengths:
- Highly organized and capable of working in a team environment with a positive attitude.
- Able to plan extra tasks independently and reprioritize when needed.
- Solution-oriented mindset with strong communication skills.
- Comfortable interacting with inspectors.
- Understands the impact of unplanned lab activities or unexpected results on product/process timelines.
Expertise:
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products.
- Knowledge of Good Tissue Practices (preferred).
- Understanding of QC IPL and EM as part of a time-sensitive chain.
- Familiarity with TMDs, process protocols, test protocols, and validation requirements.
What do we offer you?
- A meaningful job with an excellent work-life balance. You will work 4 days. After that you will enjoy 4 days off.
- A supportive and innovative work environment. We value and encourage learning and personal development.
- The opportunity to work with people from all over the world.
- A contract of indefinite duration and an attractive salary package complemented by many fringe benefits, such as additional statutory vacations, meal vouchers, group and hospitalization insurance, double vacation pay, an end-of-year and performance bonus.
- Many fun and informal events.
About Legend Biotech
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.
The company was founded in 2014 and is headquartered in Somerset, New Jersey. Legend Biotech now employs over 2,400 people across six global manufacturing sites. Two of these sites are in Ghent: Obelisc (Technology Park Zwijnaarde) and Tech Lane (Eilandje Zwijnaarde).
In Ghent, Legend Biotech focuses on the production of advanced CAR-T cell therapies for the treatment of multiple myeloma, in close collaboration with Johnson & Johnson.
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Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
Legend Biotech maintains a drug-free workplace.