Director of Product Sciences, Cell Therapy Analytical Development Job ID: REQ-10028370 Location: East Hanover, NJ, United States (On-Site) Summary We are seeking an inspiring Director of Product Sciences to design, lead, and support implementation of analytical CMC strategies to de-risk and enable early-to-late clinical development and commercialization of groundbreaking Cell Therapy products. As the Director of Product Sciences, you will lead cross-functional teams and drive product understanding by extended characterization, leveraging your wealth of knowledge in Immunology, Process, and Analytics. About the Role Key responsibilities: Generate, incorporate, and commoditize product knowledge linking immunological first-principles, patient starting material characteristics, process performance, product quality, and patient clinical outcomes via correlative analysis and mechanistic studies to support and enable Target Product Profile. Establish guidance and framework to standardize product characterization strategies. Assess and define attribute criticality (CQA vs non CQA), specification setting, and control strategy justification to enable patient access to safe and efficacious cell therapy products. Advance product pipeline through expanded capabilities and innovation to enable continued product and process understanding, extended characterization of cell therapy product, process intermediates, and starting materials to inform new cell therapy programs and improve manufacturing success. Serve as subject matter expert in T cell immunology, patient starting material, and cell therapy product characteristics. Design extended/exploratory characterization assays to assess T cell lineage, cytokine and effector molecule secretion, proliferation, degranulation, cytotoxicity, memory composition, differentiation, and exhaustion/anergic/activation status. Collaborate with cross-functional teams including Analytical Development, Process Development, Quality Control, Quality Assurance, Regulatory CMC, and Biostatistics to drive pipeline cell therapy products forward. Drive data-driven decision-making by ensuring effective data management, analysis, and reporting, and support regulatory filings as required. Requirements: Ph.D. in Immunology or a related field with 10 years of experience in understanding and characterizing the human immune system and cell products. A minimum of 5 years of industry experience in Cell Therapy CMC development. A minimum of 5 years of leadership experience, encompassing both direct and matrix management. Proven track record in early to late phase development, commercialization, and life cycle management of cell therapy products. Technical expertise in cell therapy process and product characterization, and correlative analysis. Extensive experience in regulatory filing requirements and addressing health authority questions. Exceptional communications, scientific writing, and presentation skills. Hands-on interest and experience in relevant analytical methods. Strong foundation and practical experience in statistics. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other to achieve breakthroughs that change patients’ lives. Commitment to Diversity&Inclusion: The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion, or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. J-18808-Ljbffr