Stembio - Senior CAR-T Manufacturing Expert (GMP)

Amerikan Hastanesi; Gebze; On-site; TRY 1,897,000 - 2,847,000; Full time

Job summary

A leading company in healthcare is seeking a Senior CAR-T Manufacturing Expert to support the production of innovative CAR-T cell therapies. This role involves executing and optimizing lab processes in compliance with GMP regulations, contributing to advanced cancer treatments while working in a rapidly evolving environment.

Qualifications

• At least 2 years of experience in a GMP laboratory preferred.
• Comprehensive understanding of FDA/EMA regulations and experience in GMP environments.
• Demonstrated ability to thrive in a fast-paced environment.

Responsibilities

• Perform routine CAR-T cell manufacturing operations under GMP conditions.
• Evaluate and oversee all stages of the manufacturing process, ensuring compliance.
• Lead investigations into deviations and non-conforming results.

Skills

GMP testing operations

T-cell biology

Problem-solving

Interpersonal skills

Collaboration

Analytical results analysis

Education

Ph.D. in Biology, Molecular Biology, Immunology

Job description

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.

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.