Director, Cell Therapy Analytical Development Flow, Potency & Characterization (2024)

Job ID

REQ-10013808

Jul 17, 2024

USA

Key responsibilities:

• Lead and manage a team of scientists to design, develop, and qualify analytical methods for cell therapy products, including rapid potency methods, flow cytometry-based methods, and various product characterization methods (Nanostring, Seahorse, xCelligence, Aurora etc.). Ensure methods are robust, reliable, and fit-for-purpose to support batch release and comprehensive product characterization.
• Collaborate with cross-functional teams, including Process Development, Analytical Operations, Technical Operations, Quality, and Regulatory CMC, to support development activities and ensure analytical methods are appropriately filed and implemented in a GMP environment.
• Stay up to date with the latest scientific and technological advancements in the field of cell therapy analytics, evaluate new analytical approaches, and implement innovative methods to enhance analytical capabilities.
• Provide scientific and technical guidance to the team, ensuring high-quality and timely execution of analytical development activities in alignment with project goals.
• Develop team members through mentorship, coaching, and providing opportunities for professional growth and development, fostering a culture of continuous learning and career advancement.
• Collaborate with external partners (vendors, CROs) to leverage external expertise and resources for the development of analytical methods.
• Drive data-driven decision-making by ensuring effective data management, analysis, and reporting, and support regulatory filings as required.
• Maintain a safe and compliant working environment by ensuring adherence to relevant safety guidelines, SOPs, and Development Quality Practices (DQP).
• Resource and budget management.

Requirements:

• PhD in Immunology, Cell Biology, Biochemistry, or related discipline is strongly preferred with at least 10 years of relevant experience in the biotechnology or pharmaceutical industry. Master’s degree in Immunology, Cell Biology, Biochemistry, or related discipline in a scientific discipline can be considered with at least 15 years relevant experience in the biotechnology or pharmaceutical industry.
• Proven track record of leading and managing analytical development teams and projects in the field of cell and gene therapy and/or biologics.
• Minimum of 4 years of experience in direct people management.
• Technical expertise in cell therapy analytical methods, such as potency assays, flow cytometry-based assays, and product characterization assays.
• Experience in analytical method development, optimization, qualification, and transfer, in accordance with regulatory guidelines and industry standards.
• Knowledge of cell therapy product quality attributes, specifications, and stability.
• Excellent communication, presentation, and interpersonal skills, and the ability to work effectively in a matrix organization and with external partners.
• Strong problem-solving, critical thinking, and decision-making skills, and the ability to handle multiple tasks and prioritize effectively.
• Highly motivated, self-directed, and results-oriented, with a passion for innovation and excellence.

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. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

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. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

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. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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