Senior Investigator Associate

Job Description

Legend Biotech is seeking a Senior Investigator to join their Manufacturing Science and Technology (MSAT) team in Ghent, Belgium. The Senior Investigator will play a crucial role in leading complex investigations, implementing improvement strategies, and ensuring product quality and safety within an innovative environment. This role involves contributing to a strong quality culture through risk assessments, process optimizations, and close collaboration with stakeholders. The Senior Investigator will also support regulatory inspections and mentor team members.

Role Involves:

• Leading multiple manufacturing investigations to determine root cause.
• Overseeing investigation processes and CAPA implementation.
• Representing the company during regulatory inspections.
• Strengthening partnerships with stakeholders.
• Improving product quality, safety, and efficacy.
• Mentoring and training team members.

Requirements:

• Bachelor's degree in Engineering, Science, Pharmacy, or related field.
• 8-10 years of experience in a cGMP environment within the biotech/biopharma industry.
• Experience with cell and gene therapy is a plus.
• Fluent in English (knowledge of Dutch is a plus).
• Excellent scientific writing and analytical thinking skills.
• Proven experience in independently leading quality investigations.
• Strong communication, organizational, and project management skills.
• Deep knowledge of cGMP regulations and ATMP guidelines.
• Experience with root cause analysis, risk assessment methodologies, and data analysis.

What This Role Offers:

• A meaningful job with an excellent work-life balance.
• A supportive and innovative work environment.
• Opportunities for learning and personal development.
• A contract of indefinite duration.
• An attractive salary package with fringe benefits (additional statutory vacations, meal vouchers, group and hospitalization insurance, double vacation pay, end-of-year and performance bonus).