Operations Project Investigation Expert

Company Information

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Join Legend Biotech where innovation meets life-saving cell therapies!

Role Overview

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.
• You are 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.
  
  

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.