QC Supervisor

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.

Role Overview

The QC Supervisor, CAR T, is an exempt level position with responsibilities for providing quality control over the production of personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This role includes supervision of QC analysts as well as troubleshooting issues. This role will work in shifts.

Major Responsibilities:

• Responsible for both IPC (in process analyses) as EMS (environmental monitoring).
• Ability to read, interpret and revise documents such as SOPs, work instructions.
• Develop positive relationships with the QC team, Quality Assurance, Information Technology, Maintenance, Manufacturing personnel, Technical Operations personnel, Human Resources, Site Leadership Team members, and peers.
• Harmonize with Environmental, Health, and Safety personnel, Product Development, and Quality/Manufacturing personnel.
• Independently make appropriate and compliant GMP decisions.
• Independently resolve problems through the use of quality systems.
• Develop improvement ideas and independently implement associated solutions.
• Support QC analysts team development.
• Possess the ability to positively influence peers, key stakeholders, and management.
• Generate shift schedules to ensure efficient coverage for all operational needs.
• Maintain individual training completion in a compliant state.
• Support the completion of corrective and preventive actions, as necessary.
• Support internal/external audits.
• Support Quality risk assessment teams.
• Review/approve documents as a Quality Control Subject Matter Expert (SME).
• Remain current in skills and industry trends.
• Detailed knowledge of Quality and Compliance standards.

Qualification

Education:

A minimum of a Bachelor's Degree in Science, Information Science or equivalent technical discipline is required.

Experience:

A minimum of 6 years relevant work experience is required. It is preferable that the candidate has experience working in an aseptic manufacturing facility, preferably in quality control, quality assurance, manufacturing compliance, clinical quality, or cell therapy. A minimum of 2 years of experience with quality control is preferred. A minimum of 1 year of leadership experience is also required.

Capabilities, Knowledge, and Skills:

• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing and quality control of cell-based products as well as knowledge of Good Tissue Practices.
• Strong interpersonal and written/oral communication skills.
• Ability to quickly process complex information and often make critical decisions with limited information.
• Ability to handle multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities.
• Proficient in applying process excellence tools and methodologies.
• Ability to independently be responsible for a portfolio of ongoing projects.
• Ability to pay attention to details and follow the procedures.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Good written and verbal communication skills are required.
• Ability to summarize and present results, and experience with team-based collaborations is a requirement.
• Experience directly supervising employees is preferred.
• Ability to work with and lead others in a team environment.
• Experience developing and setting long-term objectives.
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
• Ability to identify/remediate gaps in processes or systems.
• Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.
• Experience reviewing/auditing documentation.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).

Language(s):

Dutch & Technical English