• Job Description

  Req#: 386007BR
  The Executive Director, Process Development for Gene Therapies, leads the Process Development function for TRD (Technical Research & Development) Cell & Gene Therapies, comprising of multiple functions supporting all viral vector development. Shape, develop, and lead its strategic and scientific direction and drive operational excellence in line with TRD Biologics & CGT vision and strategy. Acts as an ambassador for the Novartis Culture – Inspired, Curious and Unbossed.
  
  *This position also has the ability to be located at our San Diego, California facility.
  
  Your responsibilities will include, but are not limited to:
  
  • Leads Process Development function for Gene Therapies in TRD, comprising multiple development projects in various locations
  • Develop, implement, drive and regularly refine the global strategy for process development in line with TRD CGT vision and strategy, as well reflecting customer needs and expectations
  • Build and maintain an effective, agile, high performing multi-site organization that consistently supports existing and future product portfolio. Ensure efficient processes and business practices, drive continuous, knowledge exchange and lessons learnt.
  • Ensure optimal resource allocation and appropriate make vs. buy decisions in alignment with project priorities, technology strategy and business impact in line with TRD CGT governance processes
  • Optimize laboratory utilization and efficiency, while fully supporting clinical demands
  • Closely work and align with partner functions within Gene Therapies, TRD CGT, and Biologics TRD.
  •Establish and maintain strong business relations and interfaces to key partners and stakehold-ers such as Technical Operations, Biomedical Research, Development, Quality, Procurement, RA CMC etc.
  • Proactively shape the process development environment by fully utilizing internal and external know-how as well as cutting edge technologies, techniques and approaches, continuously push and operationalize innovation and data & digital initiatives in line with TRD CGT strategy
  • Achieve a true culture of collaboration, empowerment, innovation, diversity and inclusion, trust, high performance and continuous learning
  • Drive talent acquisition and retention, succession planning and professional development of all associates to fully unleash their potential
  • Actively coach and develop direct reports
  • Ensure compliance with all relevant regulations (e.g. ISEC, GMP and HSE) and establish related accountabilities within the organization
  • Ensure high quality source documents and dossier modules (where applicable) for regulatory submissions
  • As a member of the TRD CGT global leadership team, actively contribute to TRD CGT strategy, vision and operations; represent TRD CGT at cross-functional decision-/governance boards (as appropriate)
  • Closely works with the partners within Research and Development organizations to expedite the advancement of Cell Therapies based pipeline projects toward successful IND filings.
  • Provides technical expertise to guide the development of new and/or improved processes for consistent, high-quality production.
  • Provides authorship and/or feedback for the regulatory CMC packages related to the manufacturing processes for IND filings and applications for approval (BLA/MAA/NDA).
  • Provides timely responses to process development requests from health authorities during the global filings of the product for ongoing approvals.
  • Oversees and ensures the timely delivery of process development, qualification and transfer from PD to Operations for GMP manufacture.
  • Oversees and ensures the timely delivery of all the post-approval commitments of commercial product to the health authorities.
  • Manage day-to-day operations of the Gene Therapy Process Development department.
  • A member of the Global TRD CGT Leadership Team.
  • Other related job duties as assigned.

• About the company

  At Novartis, we are reimagining medicine to improve and extend people’s lives. We are working hard to produce breakthroughs and address unmet needs for patients with devastating diseases, including genetic disorders and certain deadly cancers. Learn mo...

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