Exec Director Process Development Cell Therapy - East Hanover, United States - Novartis

Novartis
Novartis
Verified Company
East Hanover, United States

4 weeks ago

Mark Lane

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Mark Lane

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Description

Summary:


Location:

East Hanover, NJ The Executive Director, Process Development for Cell Therapies, leads the Process Development function for TRD Cell & Gene Therapies, comprising of multiple functions.

Shape, develop, and lead its strategic and scientific direction and drive operational excellence in line with TRD Biologics & CGT vi-sion and strategy.

Acts as an ambassador for the Novartis Culture - Inspired, Curious and Unbossed.


About the Role:


Your Key Responsibilities:


  • Leads Process Development function for Cell 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 multisite 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 Cell Therapies, TRD CGT, and Biologics TRD.
  • Establish and maintain strong business relations and interfaces to key partners and stakeholders such as NTO, NIBR, GDD, Quality, Procurement, RA CMC etc.
  • Proactively shape the process development environment by fully utilizing internal and external knowhow 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 crossfunctional 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 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 postapproval commitments of commercial
- product to the health authorities.

  • Manage daytoday operations of the CT Process Development department.
  • A member of the Global TRD CGT Leadership Team.

Role Requirements:


  • Ph.
D. in cellular biology, virology, chemical engineering, Molecular Biology, Biology, Genetics, Analytical/Organic

  • Engineering and/or related natural science discipline
  • 15 years of process experience in developing, qualifying, validating, and tech transferring manufacturing processes
  • A combination of education and specialized cell therapy experience may be considered to meet the required years of experience for the level of this position.
  • Knowledge in GxP compliance and data integrity is required to ensure smooth transition of the qualified method to Operations.
  • Prior experience in the cell therapy and/or other advanced therapeutics is strongly preferred
  • Proven track record of outstanding management and leadership skills to build and oversee a large, highperforming team (50+ members) with diversified expertise including cell therapies in CAR-T and/or human stem cells, gene editing, process development, transfer, and validation, and process automation.
  • Demonstrated ability with wellestablished reputation in developing, transferring, and implementing innovative, valueadded manufacturing processes from scratch.
  • Diversified experience and knowledge in a wide spectrum of CMC development suitable for adequately producing cell therapeutics. Strong communication and presentation skills in English.

Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passio
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