Investigator Associate at Legend Biotech

As a pivotal figure within our Manufacturing Science and Technology (MS&T) team, these are your responsibilities: 

✔ Lead production investigations: You will conduct thorough production investigations within our manufacturing process in accordance with GMP standards and regulatory requirements to ensure timely and safe product releases. Working with multidisciplinary teams, you quickly identify and resolve root causes of incidents, implementing robust corrective and preventive actions (CAPAs). 

✔ Act as SPOC for regulatory agencies: You will serve as the primary contact for regulatory agencies during inspections and defend investigation strategies and reports. 

✔ Drive continuous improvement: You champion the research process and methodology and implement process improvements based on lessons learned. One of your missions is to reduce recurring deviations by leading challenging trend investigations. 

✔ Build strong partnerships: You liaise with various stakeholders to ensure efficient execution of process validation and production schedules. You facilitate seamless knowledge transfer between functions and locations for effective problem solving.  

Education: 

✔ You have a master's degree in engineering, science, pharmacy or a related field of study or you are equivalent through experience.

Experience: 

✔ You have at least 3 years of operational experience within a cGMP environment in the biotech or pharmaceutical industry, preferably within cell and gene therapy.   

Languages: 

✔ You are fluent in Dutch or English, with strong oral and written communication skills.   

Strengths: 

✔ You are a born team player with strong analytical, problem solving and relationship skills. Your positive, proactive and results-oriented attitude is what really typifies you. Even in a fast-paced environment and under stressful conditions, you know how to keep your cool and meet critical deadlines.  

Expertise:

✔ You have thorough knowledge of cGMP regulations and FDA/EU guidelines related to ATMPs. You have a razor-sharp scientific pen.   

✔ 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 global biotechnology company dedicated to developing, manufacturing and commercializing innovative and life-saving cell therapies, including treatments for intractable diseases such as cancer.  

Legend Biotech was founded in 2014 and now employs over 2,400 people across six global manufacturing facilities. Two of these are located in Ghent: Obelisc (Technologie Park, Zwijnaarde) and Tech Lane (Eilandje Zwijnaarde). Our headquarters are based in Somerset, New Jersey (USA).

In Ghent, we specialize in the production of advanced CAR-T therapies for the treatment of multiple myeloma, in collaboration with Johnson & Johnson. 

1. You answer a few short questions.
2. You upload your resume or email it later.
3. You will receive a confirmation of your application.
4. Hannelore from Legend Biotech will contact you.