We are seeking a highly skilled, passionate, and motivated scientist to join our Bioproduct Research and Development team. This position will play a key lab-based role in iPSC gene editing and will contribute to the development of next-generation islet cell therapies. Ideal candidates will have extensive hands-on experience with human iPSC culture, CRISPR-based gene editing, molecular biology, and assay development. The successful candidate will be responsible for daily R&D and GMP gene-editing operations, including iPSC culture, gene editing platform development and optimization, documentation preparation (SOP and batch record drafting and review), deviation investigation, raw material screening, clone characterization, and as well small-scale iPSC derived islet differentiation.Key Responsibilities:Lab-based role focused on advancing CRISPR-based iPSC gene editing and iPSC cell line generation to enable GMP readiness.Develop and optimize gene-editing workflows, including gRNA design, RNP delivery, knock-in cargo design, clone genetic screening, and cell banking.Characterize edited iPSC clones using DNA-based assays (PCR, qPCR, ddPCR), sequencing, flow cytometry, and next-generation sequencing (NGS).Evaluate and implement iPSC culture media optimization and gene editing strategies to ensure genomic stability of iPSC lines.Support and refine directed differentiation of iPSCs into islet cells and characterize resulting drug product attributes.Perform hands-on iPSC gene editing within GMP settings to generate clinical-grade cell lines.Draft, review, and execute SOPs and master batch records; ensure compliance with GMP, regulatory, and quality standards; support deviation investigations and maintain thorough documentation.Participate in supplier qualification and sourcing of critical raw materials and consumables to ensure GMP readiness.Demonstrate strong teamwork, communication, and organizational skills to manage multiple projects and timelines effectively.
