Jobs at GC Therapeutics

GC Therapeutics is seeking a highly motivated Senior Scientist or Principal Scientist to join our Process Development (PD) team. This role focuses on iPSC scale-up and differentiation from benchtop to production-scale bioreactors. The ideal candidate will have deep expertise in induced pluripotent stem cell (iPSC) process development, scale-up and differentiation and will contribute to the development of cGMP processes for early-phase clinical trials as part of a team developing iPSC derived cellular products and related quality control assays. 

• Design and execute process development experiments to optimize and troubleshoot upstream and downstream manufacturing processes for iPSCs and iPSC-derived cells including culture, expansion, differentiation, isolation, formulation, sterile filling, and cryopreservation.
• Scale iPSC expansion and iPSC differentiation processes from benchtop to bioreactor production for GMP manufacturing.
• Execute process optimization studies using QbD principles (e.g., FMEA, DOE) to define Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs), ranges and criteria for iPSC scale-up and differentiation.
• Analyze and interpret experimental data, ensuring comprehensive documentation of methodologies and outcomes.
• Troubleshoot upstream and downstream iPSC bioprocessing challenges, improving process robustness for GMP readiness.
• Implement process changes for GMP compliance and support technology transfer to manufacturing.
• Contribute to the development of product characterization assays (e.g., identity, purity, potency, mechanism of action and functional assays).
• Draft and review technical reports, regulatory support documents and CMC regulatory submissions (e.g., Module 3, IMPD).
• Author batch records for technology transfer and provide on-the-floor support for clinical-grade cell manufacturing.
• 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. Experimental Techniques: Cellular Biology:
• Design and execute synthetic biology-based differentiation of iPSCs.
• Optimize, and scale iPSC derived differentiation for therapeutic cell products.
• Perform assays including flow cytometry, ELISA and microscopy.
• Conduct DOE studies to optimize parameters affecting engineered iPSC growth and differentiation. Molecular Biology:
• Perform PCR, qPCR and ddPCR for cell characterization.
• Characterize target cells using next-generation sequencing (e.g., library preparation for bulk and single cell RNA-seq)
• Conduct genome integrity assessment and off-target characterization
• Lead experimental design, data analysis, and presentation of results to team members.

• Advanced degree in biochemical or biomedical engineering, cell therapy, or a related field with 5+ years of industry experience.
• Strong expertise in iPSC scale-up, differentiation, and process development using 3D culture and bioreactor systems.
• Hands-on experience with upstream and downstream bioprocessing (e.g., cell expansion, transfection, isolation, formulation, sterile filling, cryopreservation, etc.).
• Experience with documentation management systems.
• Familiarity with relevant guidelines from the FDA, EMA and ICH.
• Proficiency in statistical analysis tools (e.g., JMP, SigmaPlot, Stata).
• Strong problem-solving, analytical, and documentation skills.
• Ability to work independently and collaboratively in a cross- functional team.
• Willingness to work outside normal hours including weekends to support lab activities as needed.

Additional Preferred Qualifications:

• Experience in genome editing and characterization of engineered cells.
• Proven track record and strong publications in stem cell or developmental biology.
• Knowledge of next generation sequencing (NGS), bioinformatics (R, Python), Bionano instrument and FlowJo.
• Expertise in genome integrity assessment and off-target characterization.
• Familiarity with automation, high throughput (HTP) imaging and cell cloning.