Research Associate/Associate Scientist - Cell Line Development

Job Purpose

GC Therapeutics is seeking a highly motivated Research Associate or Associate Scientist to join our Cell Line Development (CLD) team. This role focuses on iPSC scale-up and differentiation from benchtop to production-scale bioreactors. The ideal candidate will engineer novel cell therapy products derived from human induced pluripotent stem cells (iPSCs) for regenerative and cell-based therapies and will contribute to the development of cell line candidates for early-phase clinical trials as part of a team developing iPSC derived cellular products and related quality control assays.

Duties and Responsibilities

• Culture iPSC lines including maintenance and analysis (e.g. cell culture, preparation of media, passaging, cryopreservation)
• Perform cell engineering on iPSCs to generate products for cell therapies.
• Execute experiments to optimize cell engineering processes for iPSCs and iPSC-derived cells.
• Perform, analyze and interpret experimental data, ensuring comprehensive documentation of methodologies and outcomes.
• Maintain a detailed laboratory journal, summarize results, and create presentations for internal meetings
• Troubleshoot iPSC cell line engineering challenges, improving process robustness for GMP readiness.
• Implement process changes for GMP compliance and support technology transfer to process development team.
• Contribute to the development of product characterization assays (e.g., identity, purity, potency, mechanism of action and functional assays).
• Draft and review batch records, SOPs and regulatory support documents for cell line engineering processes.
• Maintain accurate and complete records, ensuring compliance with documentation management systems.
• Collaborate with a multidisciplinary team including Analytical Development, Quality Assurance, Manufacturing, Operations, R&D, etc.

Essential Qualifications

• BS or MS degree in cell biology, biochemical or biomedical engineering, cell therapy, or a related field with 2+ years of industry experience.
• Strong expertise in iPSC culture and maintenance, cell engineering, characterization of engineered cells, and single cell cloning.
• Hands-on experience with various cell type differentiation, characterization and analysis, including flow cytometry and microscopy.
• Knowledge of iPSC 2D and 3D cultures.
• Analyze differentiated cell products.
• Optimize, refine and scale differentiation protocols for candidate cell therapeutic products.
• Experience with documentation management systems.
• Experience with working in the Controlled Non-classified Space.
• Experience in quality management system and data analysis tools.
• Solid problem-solving, analytical, and documentation skills.
• Ability to work collaboratively in a matrix organization.
• Willingness to work outside normal hours including weekends to support lab activities as needed.

Experimental Techniques

Cellular Biology: General iPSC maintenance skills (passage, cryopreservation, scale up). Execute synthetic biology-based differentiation of iPSCs. Optimize, and scale iPSC derived differentiation for therapeutic cell products. Perform assays including flow cytometry, ELISA, ICC, cell-based assays and microscopy.

Molecular Biology: Perform PCR, qPCR and ddPCR for cell characterization. Conduct genome integrity assessment and off-target characterization.

General Laboratory: Perform designed experiments, data analysis, and presentation of results to team members. Maintain detailed and well-organized records of all experimental activities. Ensure compliance with GDP, GMP, safety regulations, and company policies. Stay current on scientific advancements and contribute to innovative research.

Additional Preferred Qualifications

• Experience with operations in GMP facilities and GMP guidelines.
• Hands-on experience with ELISA.
• Experience in scale-up, process development using 3D culture, organoids and bioreactor systems.
• Experience with molecular biology tools for integration site and off-target analysis.
• Knowledge of FlowJo, next generation sequencing (NGS), bioinformatics (R, Python).
• Experience in genome integrity assessment and off-target characterization.
• Familiarity with automation, high throughput (HTP) imaging and cell cloning.
• Familiarity with relevant guidelines from the FDA, EMA and ICH.