Responsibilities:
• Design and execute process development experimental plans and provide associated protocols and final reports, present updates and data to teams.
• Lead the design and execution of process development studies using QBD principles to develop a thorough understanding of operation performance parameters for T cell manufacturing process.
• Lead from the lab to advance novel and differentiated cell therapy products toward clinical milestones, by working collaboratively with internal cross-functional teams and external partners.
• Evaluate, develop and implement functionally closed systems for T manufacturing process.
• Oversee development activities for platform production processes and ensure processes are suitable for early-stage cGMP clinical development.
• Identify and evaluate new technologies to improve manufacturing outcomes such as: reduce costs, throughput, and quality.
• Perform in-vitro cellular assays involving flow cytometry, cytotoxicity, and functional characterization of genetically engineered primary T cells.
• Contribute to regulatory filings as needed for IIT and IND submissions.
• Support the technology transfer of the manufacturing process within Legend as assigned.
• Accurately capture data in a timely manner, ensuring data integrity and protocol compliance.
Qualifications:
• PhD in Biological Sciences or related fields with 3 to 6 + years of experience working within biologics process development; Previous experience and working knowledge of T-cells or immunological cell therapies.
• Experience with cell therapy manufacturing scale up, process development and process optimization are required.
• Create methods to monitor cellular immunophenotypes engaged in selection, activation, transduction, expansion and cryopreservation
• Develop methods to understand cellular impurities and impacts of cellular expansion, formulations/cryopreservation
• Experience with functionally closed systems or early technology evaluations for large-scale autologous or allogenic CAR-T cells processing are highly desirable.
• Experience with cell-based functional assays using engineered and/or primary human cells are preferred.
• Good working knowledge in cGMP manufacturing of biological process and ICH regulations.
• Good coordination and communication skills are required. Highly organized and efficient, able to work independently.
• Strong problem-solving skill is preferred. Ability to coordinate parallel tasks across multiple projects, demonstrating prioritization.

其他信息
语言要求：英语
行业要求：全部行业