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, 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 commercialize 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. Legend Biotech is seeking a CQV Specialist I (Contractor) as part of the Technical Operations team based in Raritan, NJ.

Role Overview This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant.

Requirements

This role will require CQV and engineering experience, ability to work independently, drive effective communication, coordination and collaboration across relevant cross functional groups to establish a strong, compliant CQV program to enable robust production, testing and release of product to patients.

Works in a collaborative team setting with Quality, Manufacturing Operations, Facilities Engineering Quality Control, Operations Technical Support, Supply Chain and Planning. A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required. A minimum of 4 years relevant work experience is required.

It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance. Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing 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. Proficient in applying process excellence tools and methodologies. Ability to independently be responsible for a portfolio of ongoing projects.

Key Responsibilities

Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plant to support facility, equipment, utility and computerized system validation Support multiple and complex CQV projects, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks Supports technical and quality investigations, CAPAs and corrections Develops and performs any required remediation efforts and associated CAPA plans Authors, owns and executes master and completed CQV protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria, specifically data integrity Executes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentation Participates in authoring Risk Assessments, FMEAs, Periodic

Qualifications

, Project Plans, Master Plans, and Annual Product Reviews