Clinical Manufacturing Operations and Sciences Sr. Advanced Specialist, Viral Vector

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

Role Overview

The Clinical Manufacturing Operations and Sciences Sr. Advanced Specialist, Viral Vector 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 viral vector 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 viral vector product candidates within the facility.

Key Responsibilities

• Create and author manufacturing procedures necessary to operate a viral vector suite within a GMP manufacturing facility at Phase 1 clinical standards.
• Author facility risk and gap assessments for implementation of GMP viral vector manufacturing.
• Collaborate with Technical Development teams to identify GMP viral vector manufacturing equipment.
• Act as the primary manufacturing point of contact for study, and clinical manufacturing execution escalations for multiple viral vector GMP processes.
• Provide manufacturing oversight, training, and support within the manufacturing cleanroom environment.
• Drive 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 viral vector 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.
• 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 viral vector GMP manufacturing including operations, supervision, tech transfer, and strategy setting.
• Knowledge and experience with viral vector manufacturing and tech transfer.
• Experience establishing and operating in a GMP environment.
• Experience and knowledge of viral vector manufacturing equipment.
• Pragmatism in applying GMP in a phase-specific manner in the best inte