Operations Specialist

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we develop 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 pursue the discovery of safe, efficacious and cutting‑edge therapeutics for patients worldwide.

Legend Biotech has entered into a global collaboration agreement with Janssen, a Johnson & Johnson pharmaceutical company, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). This partnership combines the strengths of both companies to advance an immunotherapy for multiple myeloma.

Location:

Raritan, NJ

This position provides operational support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. The Operations Specialist partners with Technical Operations to deliver safe and compliant personalized cell therapy production that meets cGMP requirements. Responsibilities include driving and implementing improvements, ensuring alignment with plant objectives, and collaborating across cross‑functional groups to enable robust production, testing, and release of product to patients.

• Provides general support to all operating areas, e.g., manufacturing, warehouse, logistics, support labs.
• Collaborates with Technical Operations to supply process knowledge and expertise in GMP investigations, change controls, document control, process improvement, process validation, and data management.
• Partners with Operational Excellence to implement improvements.
• Writes, reviews, owns, and updates SOPs.
• Owns and provides assessments and takes action in support of change controls.
• Owns CAPAs and associated project plans.
• Supports events such as Root Cause Analysis (RCAs) and FMEAs.
• Participates in kaizens and other project initiatives.
• Supports any business improvement efforts.
• Supports permanent inspection readiness and actively supports internal audits and regulatory inspections.
• Provides input to studies related to process improvement and implementation of new manufacturing technologies and associated protocols.
• Provides input and supports improvements related to the aseptic environment and technique.
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
• Distance visual acuity of at least 20/40 (Snellen) in both eyes without corrective lenses or corrected to 20/40 (Snellen) or better with corrective lenses.
• Color perception: both eyes 5 slides out of 8.

• BS/BA required in a technical discipline: engineering, science or similar field.
• GMP manufacturing, warehouse and logistics experience in the biotech/biopharma industry; cell/gene therapy cGMP manufacturing experience preferred.
• Fundamental understanding of Lean principles and tools;
  Lean Six Sigma Green Belt desirable.
• 3+ years of experience leading and/or supporting improvement or remediation efforts.
• Strong understanding and proven application of problem solving tools and techniques.
• Demonstrated experience owning SOPs, change controls, investigations, CAPAs and other quality system actions.
• Ability to engage all levels of the organization, from site leadership to the shop floor.
• Proven experience working and leading in a matrix environment.
• Able to manage shifting priorities to meet critical deadlines in a fast‑paced and dynamic, growing environment.
• Strong ownership skills and the ability to work independently.
• Strong analytical, problem‑solving, and critical‑thinking skills.
• Excellent organizational and communication skills.
• Ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross‑functional issues, and balance competing priorities effectively.
• Clear and succinct verbal and…