Astellas Pharma Scientist, Process Development in Seattle, Washington
The Scientist, Process Development will be responsible for supporting critical stem cell gene editing work by reducing to practice cell culture processes, developing assays, and determining specifications.
Essential Job Responsibilities:
- Improve robustness of gene editing manufacturing processes.
- Evaluate and reduce to practice new technologies to improve robustness, increase speed, and reduce costs.
- Develop assays and specifications for testing pluripotent stem cells lines prior to manufacturing, as part of in-process testing, and for release criteria.
- Author process development reports, qualification documents, and procedures.
- Clear and effective communication with personnel in other departments, including internal technology transfer to other Astellas sites.
- Summarize and present data in group meetings, author reports, and contribute to discussions.
- Mentor and supervise process engineers.
- A Ph.D. in Biochemical or Chemical Engineering, Cell Biology.
- Experience with process optimization using statistical designs.
- Strong organizational, time management, and problem solving skills.
- Ability to work independently or in a team in a goal oriented environment.
- Smart, hardworking, and motivated to work in an exciting environment delivering on the promise of next generation of stem cell therapy products.
- Experience culturing mammalian cell lines.
- Experience with cell culture automation and robotics.
- Experience with image analysis.
- Experience with aseptic manufacturing techniques and contamination control.
- Experience in GLP or GMP industry environment.
- Experience training and leading a team of research associates or technicians.
The statements above are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Research and Development