Stembio - Senior CAR-T Manufacturing Expert (GMP)

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 a motivated and detail-oriented Senior CAR-T Manufacturing Expert (GMP) for Stembio to support the production of CAR-T cell therapies in a GMP-compliant environment.

This role involves executing and optimizing cell therapy manufacturing processes, ensuring adherence to cGMP regulations, and collaborating with cross-functional teams to maintain high-quality standards. This position offers an opportunity to contribute to cutting-edge cancer treatments while gaining experience in a fast-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 2 years of experience in academia or industry.
• Minimum 2 years of experience in a GMP laboratory preferred.
• Strong expertise in GMP testing operations and a deep understanding of T-cell biology .
• Prior experience in CAR-T cell manufacturing (R&D); GMP experience is highly desirable.
• Proven ability to work independently in problem-solving, conducting lab investigations, and implementing CAPA strategies.
• Strong interpersonal and collaboration skills, with the ability to work effectively within teams and across multiple sites.
• Comprehensive understanding of FDA/EMA regulations and experience working in a GMP-compliant environment.
• Demonstrated ability to thrive in a fast-paced team environment, quickly adapt to new technologies, and acquire new technical skills.

Key Responsibilities

• Perform routine CAR-T cell manufacturing operations under GMP conditions, ensuring compliance with regulatory and quality standards.
• Evaluate and oversee all stages of the manufacturing process , ensuring strict adherence to GMP compliance.
• Play an active role in establishing and optimizing GMP laboratory operations , contributing to process improvements and regulatory alignment.
• Develop, plan, issue, and manage production schedules and material requirements to ensure efficient workflow.
• Facilitate the execution of production plans , proactively identifying and resolving operational challenges.
• Monitor and track deviations and key process parameters , generating reports and providing insights to management.
• Conduct routine sample testing (in-process, release, and stability) under GMP or non-GMP conditions, ensuring data accuracy and laboratory maintenance.
• Analyze and trend analytical results , identifying patterns to enhance product quality and process efficiency.
• Author, review, and revise key documents, including SOPs, method validation/transfer protocols, and technical reports , in alignment with regulatory and internal standards.
• Lead investigations into deviations and non-conforming results, determining root causes and implementing corrective and preventive actions (CAPA) efficiently.
• Ensure full compliance with GMP/GLP regulations , maintaining the highest quality and safety standards in manufacturing operations.

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