Stembio - Junior 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 Junior 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

• Master’s degree in Biology, Molecular Biology, Immunology, or a related scientific discipline.
• Minimum 2 years of experience in academia or industry; experience in a GMP laboratory is a plus.
• Strong understanding of GMP testing operations with expertise in T-cell biology.
• Previous experience in CAR-T cell manufacturing (R&D); GMP experience is preferred.
• Ability to work independently in problem-solving, conducting lab investigations, and implementing corrective and preventive actions (CAPA).
• Strong teamwork and communication skills, with the ability to thrive in a fast-paced, collaborative environment and quickly learn new technical skills.

Key Responsibilities

• Perform routine CAR-T cell manufacturing operations under GMP conditions, ensuring adherence to quality and regulatory standards.
• Understand, evaluate, and ensure GMP compliance at every stage of the manufacturing process.
• Play an active role in establishing and optimizing GMP lab operations , contributing to process development and compliance improvements.
• Support and/or oversee method qualification, transfer, and validation , including protocol development and execution.
• Conduct routine sample testing (in-process, release, and stability) under GMP or non-GMP conditions, ensuring laboratory maintenance and data integrity.
• Analyze, review, and trend analytical results to ensure consistency and compliance with quality standards.
• Author, review, and revise SOPs, method validation/transfer protocols, and technical reports in alignment with regulatory and internal requirements.
• Maintain strict adherence to GMP/GLP regulations , ensuring high-quality manufacturing standards and compliance.

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