Product Development: Sr. Research Associate/Research Scientist 製程開發: 資深助理研究員/研究員

【About the role】 We have an exciting opportunity for motivated individuals to join our CMC team working to develop cell therapies against cancer. The successful candidate will be expected to be a good team player, work with enthusiasm to execute assignments properly. This role is pivotal in translating our cutting-edge research into a robust and scalable manufacturing process, directly impacting our ability to deliver novel therapies to patients. 【Position Title】 Sr. Research Associate / Research Scientist (Process Development) 【Location】 Taipei, Taiwan 【Reports to】 Principal Scientist 【Job Type】 Full-time 【Responsibilities】 • Design and execute experiments for the development, optimization, and scale-up of immune cell manufacturing processes, including cell isolation, expansion, and cryopreservation. • Troubleshoot and resolve process challenges, utilizing a systematic approach (e.g., root cause analysis) to improve process robustness, yield, and consistency. • Evaluate and implement new technologies and equipment (e.g., closed-system bioreactors) to enhance process efficiency and product quality. • Perform cell manufacturing in a cleanroom environment under GTP/GMP guidelines, including meticulous execution of batch records and adherence to stringent aseptic techniques. • Perform in-process controls (IPCs) and product release testing, including cell count, viability, flow cytometry, and other characterization assays. • Author and revise technical documents, including standard operating procedures (SOPs), batch records, and development reports. • Establish the optimized manufacturing processes at the GMP manufacturing site. • Execute and document experiments to support the CMC (Chemistry, Manufacturing, and Controls) section for IND filings. 【Qualification】 • MSc (or above) in life science or related fields (e.g., Immunology, Cell Biology, Bioengineering, Biochemistry). • Minimum of 3 years of hands-on experience in mammalian cell culture with stringent aseptic techniques, preferably with primary human immune cells (e.g., T cells, NK cells). • Hands-on experience with multi-color flow cytometry for immunophenotyping. • Proven ability to work independently in experimental design, execution, and data analysis. • Excellent communication skills and ability to work collaboratively in a team-oriented environment. 【Preferred Qualifications】 • Experience in cell therapy process development, including the use of Design of Experiments (DoE) methodology. • Experience working in a GTP/GMP regulated environment. • Hands-on experience with closed-system cell processing platforms (e.g., CliniMACS, WAVE, bioreactors, cell processing system). • Experience with cell-based functional assays (e.g., cytotoxicity assays, cytokine release assays). • Experience in authoring technical documents such as SOPs or development reports. • Experience with cryopreservation development and optimization.