Exec Director Process Development Cell Therapy

4 weeks ago

East Hanover, United States Novartis Full time

**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 develop-ment 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 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 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 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 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, high-performing 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 well-established reputation in developing, transferring, and implementing innovative, value-added 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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