Sr. Expert, Product Sciences - Cell Therapy Analytical Development

Job Description Summary

Job Description

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.

The salary for this position is expected to range between $114,100 and $211,900 per year.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

Skills Desired