Viral Vector Principal Scientist

Company Information

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 and natural killer (NK) cell-based immunotherapy. 

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) in 2017. 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 Viral Vector Principal Scientist as part of the Technical Development team based in Somerset, NJ. 

Role Overview

This position will be responsible for supporting viral vector process development and GMP manufacturing for Legend’s gene and cell therapy clinical pipeline. Reporting to the Associate Director of Viral Vector Sciences within the Technical Development team, this role will work closely with external CDMOs and internal cross-functional teams, including analytical, quality, and regulatory leads, to develop and deliver required viral vector material. The successful candidate will be a collaborative and flexible individual with viral vector, GMP manufacturing, and CDMO experience. 

Key Responsibilities  

• Support process and analytical development and production of lentivirus and retrovirus at the research, process development, and GMP production scale for use in clinical cell and gene therapy project activities.
  
• Support CDMO selection process through technical and GMP focused evaluations.
  
• Assist with testing and process changes, the evaluation of new offered technologies or capabilities, and provide support to CDMOs during execution of project activities.
  
• Ensure successful execution of internally aligned viral vector process and analytical strategy .
  
• Monitor vector timelines and collaborate internally to manage vector demand and inventory. Track demand for both research-grade vector for development activities and GMP vector for clinical use.
  
• Collaborate with quality and regulatory functions to ensure GMP practices are followed by external partners and implement appropriate controls.
  
• Support GMP batch release and batch record review activities with quality partners, support change controls and deviations as necessary.
  
• Conduct technical discussions & meetings with internal and external stakeholders.
  
• Troubleshoot viral vector production process and analytical issues and proactivity identify risks and weaknesses.
  
• Author and review technical documents, protocols, and reports, including providing SME support to regulatory for USA, China and EU regulatory filings.
  
• Some travel required. 

Requirements

• BS/MS/PhD (or relevant experience) in virology, molecular biology, immunology, cell biology, chemical engineering, biomedical engineering or other related sciences preferred.
• 7-15 years of relevant experience in viral vector development, GMP production, and/or analytics.
• Expertise in suspension lentiviral and/or retroviral vector process development, production, and testing
• Hands-on experience or high familiarity with common upstream and downstream unit operations (downstream focus complements team knowledge, considered a plus) 
• Understanding of molecular biology, viral vectors, and viral vector-based assays
• Knowledge of cGLP/cGMP guidelines
• Detail-oriented, excellent organizational skills with expertise in problem solving and solid decision-making abilities
• Excellent written and verbal communication skills are essential
• Prior GMP, MSAT, and tech transfer experience
• Experience working with CDMOs and within external manufacturing preferred
• Experience with in vivo LVV/RVV gene therapy is a plus
• Understanding of health authority regulations related to viral vectors is a plus
• Experience authoring regulatory documents is a plus
• Experience with plasmid and RN