Novartis
Sr. Expert, Product Sciences Cell Therapy Analytical Development
Novartis, East Hanover, New Jersey, United States, 07936
Senior Expert Science & Technology
Internal Title: Senior Expert Science & Technology Location: East Hanover, NJ, United States (On-Site) This position will be located at East Hanover site and will not have the ability to be located remotely. We are seeking a highly skilled and driven Senior Expert in Product Sciences to join our team in advancing transformative cell therapy products. Reporting to the Director of Product Sciences, this role focuses on driving product characterization efforts, incorporating immunological principles, and developing innovative scientific approaches to solve complex challenges in the cell therapy space. As a senior bench scientist, you will leverage your expertise in immunology, cell biology, and advanced analytical methods to generate actionable product insights and support the development of safe and efficacious cell therapy products that meet our target profiles. This role requires hands-on work in a fast-paced environment, applying scientific rigor and industry knowledge to enable data-driven decision-making. Key Responsibilities: Develop and refine advanced product characterization methods to assess quality attributes of cell therapy products, intermediates and starting material. Design and execute innovative assays to assess T cell function, lineage, cytokine production, proliferation, cytotoxicity, memory composition, differentiation, exhaustion, metabolic profiling, and omics profiling. Qualify appropriate assay parameters to ensure characterization assays are fit for purpose. Apply critical thinking skills to identify the right scientific questions aligned with product development goals. Independently design and execute experiments to address foundational and applied questions, leveraging immunological principles and cell therapy expertise. Ensure effective data collection, management, and analysis to drive data-driven decision-making processes. Support regulatory filing by providing high-quality data, technical reports, and scientific rationale. Collaborate with teams across Analytical Development, Process Development, Regulatory CMC, Biostatistics and Data Sciences to drive cell therapy programs forward. Share scientific knowledge and assay development expertise to inform decisions on attribute criticality, specification setting, and control strategies. Stay up to date on advances within immunology, cell therapy sciences, and analytical technologies. Work proactively (i.e. using statistical methodologies) to address challenges in manufacturing success and clinical outcomes through product and process understanding. Requirements: Ph.D. in Immunology, Cell Biology, or a relevant scientific field A minimum of 5 years of post-educational, hands-on experience in developing T-cell characterization assays. Industry experience preferred. Applicants must demonstrate a strong track record of bench-level assay development and product characterization in T cell-based therapies or similar therapeutic modalities. Deep knowledge of T cell biology and immunology. Familiarity with advanced analytical techniques such as flow cytometry, cell-based assays, ELISA, q/dPCR, Omics, imaging cytometry, and multiplex technologies. Strong problem solving and trouble shooting skills in a dynamic and fast-paced environment. Exceptional communications, scientific writing, and presentation skills. Desirable Requirements: Practical experience in statistics Experience contributing to regulatory filings (IND, BLA) with data packages related to cell therapy product characterization.
Internal Title: Senior Expert Science & Technology Location: East Hanover, NJ, United States (On-Site) This position will be located at East Hanover site and will not have the ability to be located remotely. We are seeking a highly skilled and driven Senior Expert in Product Sciences to join our team in advancing transformative cell therapy products. Reporting to the Director of Product Sciences, this role focuses on driving product characterization efforts, incorporating immunological principles, and developing innovative scientific approaches to solve complex challenges in the cell therapy space. As a senior bench scientist, you will leverage your expertise in immunology, cell biology, and advanced analytical methods to generate actionable product insights and support the development of safe and efficacious cell therapy products that meet our target profiles. This role requires hands-on work in a fast-paced environment, applying scientific rigor and industry knowledge to enable data-driven decision-making. Key Responsibilities: Develop and refine advanced product characterization methods to assess quality attributes of cell therapy products, intermediates and starting material. Design and execute innovative assays to assess T cell function, lineage, cytokine production, proliferation, cytotoxicity, memory composition, differentiation, exhaustion, metabolic profiling, and omics profiling. Qualify appropriate assay parameters to ensure characterization assays are fit for purpose. Apply critical thinking skills to identify the right scientific questions aligned with product development goals. Independently design and execute experiments to address foundational and applied questions, leveraging immunological principles and cell therapy expertise. Ensure effective data collection, management, and analysis to drive data-driven decision-making processes. Support regulatory filing by providing high-quality data, technical reports, and scientific rationale. Collaborate with teams across Analytical Development, Process Development, Regulatory CMC, Biostatistics and Data Sciences to drive cell therapy programs forward. Share scientific knowledge and assay development expertise to inform decisions on attribute criticality, specification setting, and control strategies. Stay up to date on advances within immunology, cell therapy sciences, and analytical technologies. Work proactively (i.e. using statistical methodologies) to address challenges in manufacturing success and clinical outcomes through product and process understanding. Requirements: Ph.D. in Immunology, Cell Biology, or a relevant scientific field A minimum of 5 years of post-educational, hands-on experience in developing T-cell characterization assays. Industry experience preferred. Applicants must demonstrate a strong track record of bench-level assay development and product characterization in T cell-based therapies or similar therapeutic modalities. Deep knowledge of T cell biology and immunology. Familiarity with advanced analytical techniques such as flow cytometry, cell-based assays, ELISA, q/dPCR, Omics, imaging cytometry, and multiplex technologies. Strong problem solving and trouble shooting skills in a dynamic and fast-paced environment. Exceptional communications, scientific writing, and presentation skills. Desirable Requirements: Practical experience in statistics Experience contributing to regulatory filings (IND, BLA) with data packages related to cell therapy product characterization.