CAR-T MSAT Senior Process Engineer - Sterilization

As a CAR-T Senior Process Engineer, you will be a key part of the MSAT team, contributing to strategic process improvements and leading the local implementation of innovative technologies. Your expertise will ensure process robustness, continuous improvement, and compliance with regulatory requirements. You will collaborate with cross-functional teams, including R&D, Global MSAT, RA, QA, Operations, and Supply Chain, to drive projects and enhance operational efficiency.

What can you expect?

Here's what you'll do:

• Lead/support the design of business cases, study design, and project implementation, influencing key stakeholders.
• Provide scientific knowledge and cGMP expertise in cell and gene therapy processes to enhance MSAT Process Improvement capabilities.
• Offer scientific support to the Investigation team for resolving complex investigations and atypical events.
• Act as a backup for management and a representative of the company when required.
  
  

Process Robustness:

• Serve as Subject Matter Expert (SME) in CAR-T manufacturing processes and analytical methods.
• Ensure seamless knowledge transfer across MSAT, the site, and other relevant facilities.
• Perform data trend analysis and statistical evaluation of product and process performance.
• Stay updated on CAR-T product and process advancements.
  
  

Continuous Improvement / Operational Excellence:

• Identify opportunities for process improvements, focusing on cost reduction, capacity expansion, and compliance enhancements.
• Develop business cases using data-based modeling and statistical analysis.
• Lead/support the implementation of large-scale projects aligned with change control strategies.
• Partner with internal teams and external vendors to implement process improvements.
  
  

Quality & Compliance:

• Provide technical assessments and recommendations for cGMP documentation, including Change Controls, investigations, and CAPAs.
• Support regulatory compliance efforts and contribute to CMC updates for regulatory submissions.
  
  

Who are we looking for?

Education:

• A minimum of a Master's degree in Engineering, Science, Pharmacy, or a related field (Advanced degree preferred).
  
  

Experience:

• 5-10 years of relevant operations experience in a cGMP environment within the biotech/biopharma industry.
• Proven experience in Cell and Gene Therapy manufacturing.
  
  

Languages:

• English required; Dutch is an advantage.
  
  

Strengths:

• Ability to work independently with minimal instructions.
• High organizational skills to manage multiple tasks in a fast-paced environment.
• Strong communication skills, both written and oral.
• Analytical, problem-solving mindset with strong attention to detail.
• Ability to build strong partnerships and work effectively in a matrixed environment.
  
  

Expertise:

• Knowledge of biologics manufacturing and/or advanced therapies.
• Strong statistical analysis skills.
• Experience in training and onboarding stakeholders.
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Outlook).
  
  

What do we offer you?

• A meaningful job with an excellent work-life balance. You will work 4 days, followed by 4 days off.
• A supportive and innovative work environment that encourages learning and personal development.
• The opportunity to work with people from all over the world.
• A permanent contract and an attractive salary package with numerous benefits, including additional statutory vacations, meal vouchers, group and hospitalization insurance, double vacation pay, and performance bonuses.
• Participation in various 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, including two in Ghent: Obelisc (Technology Park Zwijnaarde) and Tech Lane (Eilandje Zwijnaarde). In Ghent, we focus on the production of advanced CAR-T cell therapies for the treatment of multiple myeloma, in close collaboration with Johnson & Johnson.

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.