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!QualificationsPh.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 ResponsibilitiesOversee 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.Your personal data is processed for the purpose of receiving and evaluating your job application. You can find detailed information about your processed personal data and rights from the "Employee Candidate Clarification Text" under the "Human Resources" heading of our website.