GMP Manufacturing Specialist

GMP Manufacturing Specialist – Advanced Cell & Viral Vector ProductionLocation: Istanbul, Türkiye (On-site)Employment Type: Full-TimeAbout Biruni UniversityBiruni University is a premier institution driving biomedical innovation in Türkiye. With our GMP-certified cleanroom facility scheduled for completion by end of this year, we are building a center of excellence in cell and gene therapy manufacturing, focusing on viral vectors and cell-based biotherapeutics.To support global know-how transfer, Biruni provides a fully funded 3-month training placement at Harvard University for eligible candidates, focusing on best practices in advanced therapeutic production.Position OverviewWe are hiring a GMP Manufacturing Specialist to oversee and execute the production of human immune cell-derived therapeutics and viral vectors in a cGMP environment. This position offers a leadership-track opportunity to establish manufacturing protocols, support tech transfer, and manage clinical-grade production pipelines.Core ResponsibilitiesCell-Based Manufacturing: Isolate, activate, and expand human immune cells using aseptic techniques; maintain cell viability and phenotype through complex culture protocols.ViralVector Integration: Execute upstream/downstream processes involving viral vector preparation, transduction protocols, and harvest steps for ex vivo cellular engineering.GMP Facility Setup Compliance: Collaborate in facility validation, cleanroom operation protocols, and equipment qualification (IQ/OQ/PQ); maintain full regulatory compliance in manufacturing activities.Batch Records & Documentation: Prepare, review, and maintain GMP-compliant records including BPRs, SOPs, change controls, deviations, and CAPA reports.Process Transfer & Scale-Up: Partner with R&D and QC teams to optimize protocols and implement production at clinical scale; contribute to tech transfer documentation and validation runs.Quality & Equipment Oversight: Supervise bioprocessing systems such as incubators, biosafety cabinets, flow cytometry systems, closed-system cell culture platforms, and automated expansion systems.QualificationsPh.D. in Biotechnology, Molecular Biology, Immunology, Biomedical Engineering, or related field (MSc with strong industry experience also considered).Minimum 2 years of hands-on GMP experience with immune cell handling, ex vivo manipulation, or advanced biologics manufacturing.Strong understanding of cell biology, cell culture techniques, viral transduction, and bioreactor operations.Familiarity with cGMP and international regulatory standards (EMA/FDA).Exceptional technical documentation and problem-solving skills.Fluent in English (spoken and written).Why Join UsPaid 3-month training at Harvard University in advanced bioprocessing and regulatory compliance.Take part in shaping Türkiye’s leading cell and gene therapy manufacturing hub.Work with a multidisciplinary team of scientists, clinicians, and regulatory experts.Opportunities for academic collaboration and career advancement in a pioneering translational medicine environment.Application ProcessSubmit your CV and a concise cover letter outlining relevant manufacturing experience with immune cells or gene-modified cell products. GMP experience is required.