Stembio - Quality Control 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; CAR-T/TILs, 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 highly skilled and motivated Quality Control Expert for Stembio to ensure the quality, safety, and compliance of our cell therapy products.

This role involves overseeing quality control testing, participating in method validation, and ensuring adherence to cGMP, regulatory, and company standards. The ideal candidate will have a strong background in analytical techniques, process validation, and a proactive approach to maintaining product integrity.

If you are passionate about quality control in advanced cell therapies and have the expertise to uphold the highest standards, we encourage you to apply!

Qualifications

• Master’s degree or higher in Biology, Biotechnology, Biochemistry, or a related field.
• Minimum 3+ years of experience in a cGMP-regulated Quality Control environment, preferably in cell therapy, regenerative medicine, or biopharmaceuticals.
• Hands-on experience with telomerase enzyme activity assays, mycoplasma testing, sterility testing (BACTEC), endotoxin assays, flow cytometry, RT-PCR, karyotyping, ELISA, and potency assays .
• Strong understanding of process validation, assay validation, and analytical method development .
• Familiarity with regulatory requirements (FDA, EMA, TITCK, ICH guidelines) and quality management systems (QMS) .
• Excellent analytical, problem-solving, and troubleshooting skills.
• Ability to work independently and as part of a team , demonstrating responsibility and leadership in quality control functions.
• Strong communication skills with the ability to document, report, and present findings effectively .
• Experience in working with automated QC systems and LIMS is a plus.

Key Responsibilities

• Perform and oversee quality control testing for cell viability, tumorigenicity tests ( telomerase enzyme activity), mycoplasma detection, endotoxin testing, flow cytometry, RT-PCR, karyotyping, potency assays, ELISA , microbial testing, and other relevant assays.
• Ensure compliance with cGMP, EMA, TITCK and other regulatory guidelines for cell therapy products.
• Participate in method validation and process validation to establish and maintain robust testing methodologies.
• Review, analyze, and interpret QC data to ensure accuracy and reliability.
• Maintain and troubleshoot QC instruments and ensure calibration and performance qualification.
• Work closely with the production team to implement in-process controls and final product testing .
• Prepare and review SOPs, protocols, reports, and regulatory documentation .
• Investigate deviations, out-of-specification (OOS) results, and non-conformances , implementing corrective and preventive actions (CAPAs) as necessary.
• Collaborate with cross-functional teams to support continuous improvement initiatives .
• Ensure timely release of raw materials, intermediates, and final products based on QC testing results.

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