Your new company
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.
Your new role
Are you an experienced professional in the biotech/biopharma industry with a passion for quality investigations and process improvement?
Do you want to play a key role in ensuring product quality and safety in an innovative work environment?
Then this position as Senior Investigator is for you!
What can you expect?
As a Senior Investigator, you will be part of the Manufacturing Science and Technology (MSAT) team, responsible for leading complex investigations and implementing improvement strategies.
You will contribute to a strong quality culture by conducting risk assessments, leading process optimizations, and maintaining close collaborations with various stakeholders.
Additionally, you will support regulatory inspections and mentor team members.
Your Responsibilities
- Lead multiple manufacturing investigations, establishing strategies to quickly drive to root cause and meet critical release windows.
- Oversee investigation processes and standards, supporting CAPA implementation related to manufacturing processes.
- Act as the company’s representative during regulatory inspections, defending investigation strategies and responses to observations.
- Strengthen partnerships with various stakeholders to ensure smooth alignment in handling complex investigations.
- Apply expertise in scientific and cGMP principles to improve product quality, safety, and efficacy.
- Mentor and train team members, fostering a culture of learning and development.
Your profile
Education :
- Minimum of a Master’s degree in Engineering, Science, Pharmacy, or a related field.
Experience :
- 8–10 years of experience in a cGMP environment within the biotech/biopharma industry.
- Experience with cell and gene therapy is a plus.
Languages:
- Fluent in English (knowledge of Dutch is a plus).
Strengths :
- Excellent scientific writing skills and analytical thinking.
- Proven experience in independently leading quality investigations.
- Strong communication skills and the ability to build relationships.
- Positive, proactive, and results-driven mindset.
- Strong organizational and project management skills.
Expertise :
- Deep knowledge of cGMP regulations and ATMP guidelines.
- Experience with root cause analysis and risk assessment methodologies.
- Experience with advanced data analysis and presenting trends and findings.
What you'll get in return
- A meaningful job with 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.
What you need to do now
Are you interested in this role? Please click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.
#LI-DNI