Senior Investigator Associate

Senior Investigator

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.

Who are we looking for?

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.

Why choose this role?
You will be part of a dynamic and innovative environment where your expertise contributes to groundbreaking developments in cell and gene therapy. You will have the opportunity to make an impact, grow professionally, and work within an inspiring team of professionals.

Are you the Senior Investigator we are looking for? Apply now and become part of a forward-thinking company where your work makes a difference for patients worldwide

What do we offer you?

• 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
  .

About Legend Biotech

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.

The company was founded in 2014 and is headquartered in Somerset, New Jersey. Legend Biotech now employs over 2,400 people across six global manufacturing sites. Two of these sites are in Ghent: Obelisc (Technology Park Zwijnaarde) and Tech Lane (Eilandje Zwijnaarde).

In Ghent, Legend Biotech focuses on the production of advanced CAR-T cell therapies for the treatment of multiple myeloma, in close collaboration with Johnson & Johnson.

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.

Benefits:

• Health Insurance
• Dental Insurance
• Vision Insurance
• Life Insurance
• Matched 401K
• Flexible Spending Account
• Health Savings Account
• AD&D Insurance
• Short-Term Disability
• Long-Term Disability
• Paid Maternity Leave
• Paid Paternity Leave
• Pet Insurance
• Critical Illness Insurance
• Hospital Indemnity Insurance
• Accident Insurance
• Legal Insurance
• Commuter Benefits
• Employee Assistance Program