Yanni Francois

Detailed-oriented Cell and Gene therapy professional with experience in regulated manufacturing environments, ensuring compliance with SOPs, GMP standards, and quality requirements. Ability to manage critical documentation, support investigations, maintain data accuracy, and collaborate with multidisciplinary teams. Aiming to advance experience in compliance, and documentation review to support clinical trial oversight and contribute to the execution of successful clinical trials.

Cell Processing Specialist at Novartis (2025-02 – Present)

• Worked with CAR-T immunotherapy targeting multiple myeloma.
• Supported the concept of engineering a patient's own T-cells using viral vectors to express CARs, enabling targeted recognition and destruction of tumor cells.
• Complete and review batch records, ensuring compliance with SOPs and regulatory standards.
• Monitor critical process parameters and troubleshoot deviations in real-time.
• Collaborate with Quality Assurance to investigate deviations and implement CAPAs.
• Perform cell therapy manufacturing processes including isolation, activation, transduction, and expansion of human cells under GMP conditions.
• Execute aseptic techniques in cleanroom environments (ISO 5/7/8) to ensure sterility and product quality.

Bachelor of Arts in Biology – Kean University