CAR-T Operations Project Investigation Expert

Join Legend Biotech where innovation meets life-saving cell therapies! Our Operations team in Ghent is on the lookout for a passionate Operations Project Investigation Expert. In this exciting role, you'll dive deep into investigations, pinpointing and resolving issues in our manufacturing process caused by human error. Your work will be instrumental in ensuring our products are safe and released on time. If you're driven by quality and eager to make a mark in personalized medicine, this is your chance to shine! 

What can you expect?     As an Operations Project Investigation Expert, you will have a challenging and varied set of duties. Here's what you'll do: 

• Conduct operational investigations: You will conduct in-depth investigations to quickly identify and resolve the causes of incidents due to human error in our production process. As a result, you ensure safe and timely product releases. You also implement robust investigation methods and train the team to efficiently handle quality investigations. 

• Quality and compliance: You ensure that all investigations meet the highest GMP standards and regulatory requirements. You take the lead in investigating and reporting deviations and support other departments in deviation investigations. You apply and support corrective and preventive actions (CAPAs). 

• Act as SPOC for regulatory agencies: You will act as the main contact for regulatory agencies during inspections and defend investigation strategies and reports with conviction.  

• Drive continuous improvements You will maintain and lead the research dashboard, support QEM systems and implement process improvements based on lessons learned. 

• Build strong partnerships: You will build lasting connections with various stakeholders to ensure the smooth handling of investigations.  

Who are we looking for? 

Education:  

• You have a master's degree in (bio)engineering, science, pharmacy or another related field of study or you are equivalent through experience.      

Experience:  

• You have at least 3 years of project execution experience within an operational cGMP or ATMP environment in the biotech or pharmaceutical industry. Previous experience in manufacturing, quality or engineering is essential. 

Languages:  

• You are proficient in Dutch and English, with strong written and oral communication skills.    

Strengths:  

• You are an enthusiastic team player, eager to learn and willing to solve complex technical and scientific challenges. You have excellent organizational, analytical and scientific writing skills. Your proactive, positive and flexible attitude makes it easy to build strong partnerships.    

Expertise:  

• You have knowledge of cGMP regulations and FDA/EU guidelines related to ATMPs. You have experience with risk assessment and root cause analysis. 

What do we offer you?    

• A job with impact that directly contributes to the well-being of patients worldwide.  

• An excellent work-life balance.  

• 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 the development, production and commercialization of innovative and life-saving cell therapies, including treatments for intractable diseases such as cancer.  

Since our founding in 2014 in Somerset, New Jersey, we have grown into a company with more than 2,000 employees in six manufacturing facilities worldwide.  

In Ghent, we are focusing on the production of our advanced CAR-T therapy for the treatment of multiple myeloma, in collaboration with Johnson & Johnson.