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Form of workLegend Biotech is seeking CAR-T Process Development Scientist (Multiple Levels) as part of the R&D teamBased inNanjing, China.
Key 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.
Requirements
- PhD or MS 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
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