Research Associate/Associate Scientist – Cell Line Development
Company Overview
GC Therapeutics is the first genome-wide cell landscape exploration company using an integrated synthetic biology and AI-driven platform for cell programming. Its patent-pending and proprietary pluripotent stem cell differentiation technology platform TFome™ was developed in Professor George Church’s lab, a pioneerin synthetic biology,and allows for the development of unique cell therapies with significantly streamlined manufacturing, improved cell quality, efficiency, and speed. GC Therapeutics is basedin Cambridge, MA. For additional information, please visitwww.gc-tx.com.
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.
Qualifications
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.
- 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