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Form of work1 purpose! Novartis expands its early development and innovative CAR-T Cell Therapy manufacturing capabilities in its newly launched Center of Excellence, located in the East Hanover, NJ campus. Our therapies are being developed as transformative treatments with life-saving potential for various B cell malignancies and other oncological diseases. We look to be bold with purpose, as we reimagine medicine and lead the way in advancing scientific breakthroughs for patients.
As a key member of the Cell Therapies Process Development leadership team, this individual and his/her team will be accountable for Process Development activities for current and future programs including/not limited to Process Development/optimization, technology transfers (internal and external), manufacturing support, and development of source documents for regulatory filings. Deep expertise in the field of Process Development for cell therapies is essential. Growth mentality and passion to serve patients, his/her technical team and development programs, and demonstrated people leadership is a must.
Your responsibilities will include, but are not limited to:
Provide strategic, technical and scientific leadership to the cell Process Development team, to develop, optimize, and characterize robust Cell Therapy Processes and new technology evaluation and implementation.
Collaborate closely with peer function teams and communicate complex technical topics and decisions within the department and to program teams and provide effective technical and business leadership at the R&D as well as the technical operations interface.
Ensure seamless transition of unit operations from bench-scale to clinical scale, and from open to closed manufacturing systems to develop a robust process control strategy.
Work collaboratively with Process Development leadership to develop and/or optimize Cell Therapy platforms (T cells and Stem cell therapies), to support Novartis Cell Therapy's multi-product portfolio of clinical development programs.
Provide strategic leadership and influence for the development and tech transfer of process platforms to support manufacturing of Cell Therapy products across a network of internal and external manufacturing sites.
Develop, lead and coach a group of engineers/scientists through direct supervision and/or as matrix leader.
Author and review regulatory submissions and responses to questions from health authorities.
