Qa Project Support Specialist

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.

Legend Biotech is seeking QA Project Support Specialist as part of the Quality team based in Raritan, NJ.

Role Overview

This position is an exempt level position. The position’s responsibilities include providing quality oversight over process improvement projects within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will support quality activities for continuous improvement efforts, site escalations, and quality projects.

Key Responsibilities

• Collaborates with all Quality groups and functional departments to resolve issues.
• Require minimal direction to complete tasks, knows how to get resources and information from established internal contacts; escalates to management when problems are identified, consult with supervisor or other subject matter experts for decisions outside established processes.
• Provide quality support in cross-functional projects with many stakeholders.
• Provide site Quality metrics.
• Participate/facilitate in escalations associated with batch investigations.
• Lead assigned Quality tasks associated with process improvements.
• Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.
• Provide quality and compliance input for identified continuous improvement efforts associated with the manufacturing site.

Requirements

• Ability to identify/remediate gaps in Quality processes or systems.
• Drive Change
• Strong interpersonal and written/oral communication skills
• Ability to lead projects
• Ability to work with in a team environment.
• Participated in Health Authority Inspections is a plus
• Knowledge of cGMP regulations and Health Authority guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
• Ability to independently perform assigned tasks.
• Ability to facilitate meetings
• A minimum of a Bachelor’s Degree
• A Minimum of 5 years relevant work experience is required. It is preferable that the candidate have 2 years + of experience working in Quality Assurance. Previous cell therapy experience is a plus
• Ability to handle multiple priorities daily while being flexible and responsive to frequently shifting priorities.

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