Specialist, QA Process Excellence

Legion 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, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting‑edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialise ciltacabtagene autolecuel (cilta‑cel). 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.

Location:

Raritan, NJ

The QA Process Excellence Specialist III role is an exempt level position with responsibilities for providing quality oversight for the manufacturing process and associated technical activities within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. The role also provides oversight of technical operations activities, including data or document review, risk assessments, CAPAs, and continuous improvement activities.

The Specialist serves as a subject‑matter expert for the manufacturing process and provides quality oversight for technical teams.

• Provide Quality Oversight and technical expertise to the Technical Operations and Manufacturing Teams in support of technical activities.
• Provide guidance on industry best practices, and quality requirements for maintaining a compliant state for manufacturing operations.
• Provide expertise related to investigations and deviations occurring during routine manufacturing and protocol‑driven activities such as tech transfer and process validation.
• Assist in the development of process, operational, and quality improvements for manufacturing.
• Assist in the review and development of process‑related protocols and documentation.
• Provide technical quality oversight for electronic batch records.
• Support manufacturing and technical operations teams in troubleshooting and resolving complex scientific / technical problems.
• Evaluate quality processes and system standards to ensure compliance with applicable internal standards, industry standards, and global regulations.
• Provide Quality Oversight for batch records, change controls, SOPs, non‑conformances, risk assessments, and CAPAs associated with manufacturing and technical operations and ensure effectiveness of related actions.
• Handle multiple priorities daily while remaining flexible and responsive to frequently shifting priorities.
• Work independently to perform assigned tasks.
• Perform tasks in a manner consistent with safety policies, quality systems, and cGMP requirements.
• May support CSV activities as needed.
• May support equipment qualification activities as needed.

• Minimum of a Bachelor’s Degree in Science or equivalent technical discipline.
• 5+ years relevant work experience or equivalent. Preferably experience working in an aseptic manufacturing facility within quality assurance, manufacturing compliance, clinical quality, or cell therapy; a portion of the 5 years must include quality assurance experience.
• Strong knowledge of cell therapy processes strongly preferred.
• Experience with Manufacturing Execution Systems (MES) design/development and validation preferred.
• Experience with Computer System Validation (CSV) is a plus.
• Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals.
• Experience reviewing/auditing GMP documentation.
• Strong interpersonal and written/oral communication skills.
• Ability to quickly process complex information and make critical decisions with limited information.
• Ability to work independently and to Escalate to management when required.
• Detail‑oriented…