US: Associate Director, Viral Vector Sciences

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 Associate Director, Viral Vector Sciences as part of the Technical Development team based in Somerset, New Jersey. 

Role Overview

The Associate Director of Viral Vector Sciences is responsible for supporting viral vector development, tech transfer and GMP manufacture needed to support products from clinical manufacturing through commercialization. Reporting to the Senior Director of Materials Sciences, within the Technical Development Team, this management role will work closely with organizational cross-functional teams and be responsible for viral vector development and strategy focused on Cell and Gene Therapy Programs. The successful candidate will participate in development activities with CDMOs, as well as participate as a tech transfer liaison between sending and receiving manufacturing sites to ensure manufactured products meet technical acceptance criteria, health authority guidelines and global qualification standards. 

Key Responsibilities  

• Oversee production and testing of lentivirus, retrovirus, and/or AAV at the research, process development or GMP production scale for use in clinical cell and gene therapy project activities
• Support the evaluation of new CDMO technical capabilities, assist in testing and technical changes, and provide support with CDMOs for execution of development and early clinical project activities
• Responsible for technical and organizational leadership in tech transfer of a commercial vector; in collaboration with tech transfer project manager, drive, and tack document transfer
• Responsible for designing the viral vector process and analytical tech transfer strategy and monitoring timelines
• Collaborate with quality to ensure GMP practices are followed by external partners and implement appropriate controls
• Conduct technical discussions & meetings with internal and external stakeholders and facilitate implementation of new viral vector technologies
• Troubleshooting viral vector production process and analytical issues of commercial processes, as well as and proactivity identify and mitigate risks and weaknesses
• Coordinate, 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/Ph.D. (or relevant experience) in cell biology, molecular biology, immunology, virology, biomedical engineering or other related sciences preferred
• 8+ years of experience in viral vector development, production, and analytics
  
• Understanding of molecular biology, viral vectors, and viral vector-based assays
• Expertise in viral vector production (lentiviral, retroviral, or adeno-associated virus) and technology transfer
• Understanding of plasmid production and testing is a plus
  Experience in CDMO evaluation and working with external partners
• Understanding of health authority regulations related to viral vectors
• Facilitating a multifunctional and multicultural network
• Knowledge of cGLP/cGMP guidelines
• Detail-oriented, excellent organizational skills with expertise in problem solving and solid decision-making abilities
• Strong written and verbal communication skills are essential
• Ability to operate independently and in a team environment
• English/Mandarin preferred

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Legend Biotech is a proud equal opportunity/affirmative action employe