Astellas Pharma Scientist I, Process Development in Seattle, Washington
Universal Cells is focused on the development and commercialization of stem cell and regenerative medicine therapies. We conduct clinical-grade gene editing of stem cells and have a major effort in R&D. We design and produce stem cells that avoid rejection, and we engineer cells with improved therapeutic properties, all through our world-class gene editing platform.
Our goal is to provide cells for regenerative medicine applications that can treat all patients. Through internal R&D and our corporate partnerships, we are pursuing a diverse range of disease indications, including blindness, cancer, vascular insufficiency, and autoimmune diseases.
Universal Cells (UCI) is announcing a Scientist I, Process Development opportunity at their facility in Seattle, WA.
The primary purpose of the Scientist I is to work as part of a team in planning and executing experiments to evaluate all aspects of culturing, gene-editing, and characterization processes of pluripotent stem cells. This Scientist will play a key role in the development of programs and assays to support the generation of clinical-grade, gene-edited Universal Donor Cells. This position will also be cross-trained in Good Manufacturing Practices and Good Documentation Practices and will support the Cell Editing team as needed.
Universal Cells is a wholly-owned subsidiary of Astellas Pharma. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products.
Essential Job Responsibilities:
- Designs and executes moderately complex laboratory experiments to evaluate processes and products.
- Performs data collection, analysis, and interpretation with a high degree of scientific rigor. Communicates results in both oral and written formats by participating regularly in team meeting preparations and presentations.
- Establishes and maintains scientific programs/databases.
- Collaborates with other departments to establish and tech transfer new manufacturing processes and assays.
- Prepares and reviews the work of others to include, but not limited to, technical slide decks, reports, Standard Operating Procedures (SOPs) and Production batch records.
- Supports the Process Development team as well as other departments with the maintenance of pluripotent stem cell cultures.
- Supports the Cell Editing Production team to identify and troubleshoot challenges in manufacturing processes. Serves as a subject matter expert on experimental methods and Production processes.
- Remains cross-trained on new batch documentation and protocols to support the Cell Editing Production team as needed.
- Serves as a technical resource for preparation of regulatory filings.
- Performs detailed record-keeping and communicates data analysis in a timely manner.
- Ensures smooth day-to-day operations of the cell culture lab.
- Performs other duties as assigned or special projects as needed.
- A Ph.D. in biology, genome sciences, or a related discipline with 0-3 years of relevant post-graduate laboratory experience, or a MS with 6+ years, or a BS with 8+ years of highly relevant experience.
- Solid technical background in aseptic mammalian cell culture and process optimization.
- Ability to identify opportunities for process improvement and to problem solve in a timely manner.
- Strong work ethic and adaptability with a passion for working in a fast-paced, dynamic, and diverse work environment.
- Strong organizational, time management, and problem-solving skills with scientific attention to detail.
- Ability to work effectively both independently and in collaboration with other teams.
- Excellent communication and interpersonal skills.
- Excellent record keeping.
- Experience building and managing databases.
- Ability to write and follow established SOPs.
- Willingness to learn new protocols, relevant equipment, and related software.
- Experience with culturing, editing, and/or differentiation of pluripotent stem cells.
- Experience with scale-up, fill-finish, and cryopreservation processes in cell therapy manufacturing.
- Experience with method and cellular assay development.
- Familiarity with Good Documentation Practices and working within Quality Systems.
- Experience initiating/managing/leading projects.
- Experience in leading a team and mentoring/training junior researchers.
- Experience with technical writing.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled Category Research and Development