Sr. Advanced Specialist, Clinical Manufacturing Operations and Sciences

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 Sr. Advanced Specialist, Clinical Manufacturing Operations and Sciences as part of the Technical Development team based in Somerset, NJ. 

Role Overview

The Sr. Advanced Specialist, Clinical Manufacturing Operations and Sciences will be responsible for providing technical strategies and performing related activities necessary to start up and perform routine operations within a new in-house GMP facility and delivering Phase 1 clinical trial material for several cell and gene therapy pipeline assets to patients in need.  The successful candidate will collaborate with a cross-functional team including quality, IT, facilities, safety, and operations to establish the systems necessary to operate a GMP manufacturing facility for the purpose of producing Phase 1 products.  The following activities will include tech transfer, data analysis, troubleshooting and executing manufacturing cell and gene therapy product candidates within the facility.

Key Responsibilities  

• Create and author manufacturing procedures necessary to operate a GMP manufacturing facility at Phase 1 clinical standards.
• Act as the primary manufacturing point of contact for study, and clinical manufacturing execution escalations for multiple cell and gene therapy GMP processes.
• Provide manufacturing oversight, training, and support within the manufacturing cleanroom environment.
• Manage and own Technology Transfer campaigns of new product introduction and process improvements to internal programs.
• Provide hands-on manufacturing training as needed.
• Translate process development reports into manufacturing batch records and SOPs as part of tech transfer.
• Analyze and interpret manufacturing process data.
• Perform complex manufacturing investigations including OOS, OOT, and deviations.
• Author and review investigation reports, CAPAs, and change controls.
• Review and resolve corrections in executed batch records.
• Review executed batch records and assist with corrections as required.
• Drive continuous improvement initiatives.
• Represent manufacturing operations as technical SME in cross-functional meetings and project teams, providing subject matter expertise minimally on manufacturing operations, execution trends, and manufacturing requirements.
• Coordinate with QC to transfer samples for testing and support the investigate out-of-specification results collaboratively.
• Author and lead execution of tech transfer protocols.
• Train GMP personnel on aseptic requirements and behaviors.
• Foster a culture of quality and compliance.

Requirements

• BS in cell biology, molecular biology, immunology, microbiology, biomedical engineering or other related sciences preferred.
• 5+ years of experience in cell and gene therapy GMP manufacturing including operations, supervision, tech transfer, and strategy setting.
• Knowledge and experience with cell and gene therapy manufacturing and tech transfer.
• Experience establishing and operating in a GMP environment
• Familiarity with cell and gene therapy equipment.
• Pragmatism in applying GMP in a phase-specific manner in the best interest of the patient
• Experience working in cross-functional matrices
• Excellent collaboration skills
• Ability to manage shifting priorities to meet cri