Position:
Cell process Development Scientist※No Japanese required
Salary:
¥5M~8M
Location:
Tokyo
【Company Profile】
A startup from the University of Tokyo that aims to solve global issues by utilizing cells in the field of engineering.
In order to contribute to the spread of the cell industry, including medical care, they are working on developing cell mass production technology using the company's technology.
While cell medicines are attracting attention mainly in regenerative medicine and cancer immunotherapy, the manufacturing process is still mainly manual, and rationalization of manufacturing is an urgent issue.
They aim to realize mass production of expensive cell medicines using their unique culture technology and create a society where cell therapy is within reach of everyone.
[Company/Job Attractions]The company's technology is proven, and you will be involved in a rapidly growing business that is close to monetization.
In addition, more than 10 companies are currently introducing and evaluating the technology, and they are working to establish a manufacturing and sales system for products aimed at social implementation, as well as to collaborate with CDMOs both in Japan and overseas.
In addition, the company's technology has a wide range of applications and has great business potential.【Job description】
- Design, plan, and execute scientific experiments to develop GMP-compliant processes (closed, automated, scalable, and reproducible).
- Seamlessly transfer process conditions from the research department and identify process parameters for improvement.
- Implement necessary experimental design, data acquisition, and analysis to scale up lab-scale processes to commercial manufacturing levels, identifying optimal conditions and implementing improvement proposals.
- Create and maintain accurate and up-to-date records of process development activities, experimental data, and results in compliance with GMP and other relevant regulations.
- Prepare detailed technical reports including experimental procedures, data analysis, and process improvement proposals.
- Create and support documentation such as product user manuals, FAQs, and troubleshooting guides.
- Investigate and analyze process-related issues, identify root causes, and implement corrective actions.
- Optimize processes using data analysis and statistical methods based on technical knowledge of cell culture and cell-based assays.
- Collect, record, and analyze experimental data, interpret and evaluate results, and report them to the team for process improvements.
- Maintain abreast of the latest technological and industry trends in cell therapy manufacturing, and improve process efficiency, scalability, and product quality through the adoption of innovative cell culture systems, automation technologies, and advanced analytical methods.
- Comply with experimental procedures, safety guidelines, and relevant regulations.
- Maintain a high level of experimental precision, accuracy, and reproducibility, follow safety protocols, and maintain an organized and tidy experimental environment.
- Master's degree or higher in science (biological engineering, chemical engineering, life sciences, pharmaceutical sciences, or related field) or at least three years of research, manufacturing, or development experience in the private sector
- Laboratory experience in cell culture, molecular biology, or bioprocess development
- Basic understanding of process development, including scale-up, process optimization, and technology transfer
- Experimental data collection, analysis, and reporting skills (including the use of Excel, GraphPad, statistical software, etc.)
- Ability to work in a team and communicate cross-functionally
- Basic awareness of compliance in a GxP or equivalent environment, including documentation and record-keeping
- Fluent communication skills in English or Japanese
Employment Type:
Permanent
Trial period: 3 months
Estimated annual income:
¥5M~¥8M
Work location:
Tokyo
Working hours:
Discretionary work system (with core time)
Holidays: 2 days a week (Saturdays and Sundays), national holidays
Vacation:
Summer vacation, year-end and New Year holidays, and other vacations available
Overtime:
none
Benefits:
Complete social insurance, commuting allowance (according to company regulations), and other benefits
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