Stembio - Head of Car-t Manufacturing Expert

Stembio (a Koc Holding/Koc Healthcare company) is a cutting-edge cGMP laboratory specializing in the production and preparation of cellular products such as; Mesenchymal Stem Cells (MSCs), exosomes, immunotherapy products, cord blood banking and tissue grafts. We are committed to delivering high-quality, regulatory-compliant cell therapy products through rigorous quality control and validation processes.

We are seeking an experienced and visionary Head of CAR-T Manufacturing (GMP) for Stembio to lead the production of CAR-T cell therapies in a GMP-compliant environment .

This role is responsible for overseeing all aspects of CAR-T manufacturing operations , ensuring compliance with cGMP regulations , and driving continuous process improvements to optimize efficiency, quality, and scalability. The ideal candidate will be a proactive leader with a strong technical background in cell therapy manufacturing , a deep understanding of GMP requirements , and the ability to manage cross-functional teams effectively. This is a unique opportunity to shape the future of CAR-T therapy production , contributing to life-saving cancer treatments in a rapidly evolving field.

If you are passionate about CAR-T cell manufacturing and have the expertise to uphold the highest standards, we encourage you to apply!

Qualifications

• Ph.D. in Biology, Molecular Biology, Immunology, or a related scientific discipline with at least 5 years of experience in academia or industry.
• Minimum 4 years of experience in a GMP laboratory is preferred.
• Strong expertise in GMP testing operations and a deep understanding of T-cell biology.
• Proven experience in CAR-T cell manufacturing (R&D); GMP experience is essential.
• Demonstrated ability to lead and manage a team of manufacturing experts, coordinating activities across multiple divisions to ensure seamless operations.
• Comprehensive knowledge of FDA/EMA regulations and ability to effectively communicate and collaborate with Quality Management and cross-functional teams.

Key Responsibilities

• Oversee and lead routine CAR-T cell manufacturing operations in compliance with GMP regulations.
• Act as a subject matter expert (SME), evaluating and ensuring GMP compliance at every stage of the manufacturing process.
• Develop, review, and approve critical GMP documentation, including Standard Operating Procedures (SOPs), non-conformance reports, and out-of-specification (OOS) results.
• Identify and implement process improvements across operational functions to enhance efficiency, scalability, and compliance.
• Play a key role in establishing and optimizing GMP laboratory operations, ensuring alignment with global regulatory standards.
• Lead and oversee method qualification, technology transfer, and validation activities, ensuring adherence to protocols and execution standards.
• Conduct and lead investigations into process deviations and non-conforming results, identifying root causes and implementing timely corrective and preventive actions (CAPA).
• Ensure strict compliance with GMP/GLP regulations, fostering a culture of quality and operational excellence.

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