Scientist I, Process Development
Website Universal Cells-Astellas Pharma
Universal Cells-Astellas Pharma
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world.
Universal Cells, an affiliate of Astellas located in Seattle, WA, is focused on the development and commercialization of stem cell and regenerative medicine therapies. We conduct clinical-grade gene editing of stem cells to produce cells that avoid rejection and can be used in allogeneic cell therapy treatments to treat all patients that need them.
OUR GOAL – ONE CELL FOR EVERYONE
NO IMMUNE SUPPRESSION. NO DONOR MATCHING. NO REJECTION.
We are a dynamic team of research and scientific professionals who are passionate about turning science and innovation into medical solutions. Through our diversity, scientific knowledge, professional rigor and focus on innovation, we are merging our technology with the Astellas drug development expertise to unlock cures to many therapies. Join our team of committed enthusiastic professionals devoted to making the most effective, life-saving cell therapy products in the world.
The primary purpose of the Process Development Scientist I is to work as part of a team planning/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 Clinical Gene Editing team as needed.
Essential Job Responsibilities:
- Designs and executes complex laboratory experiments and cell-based assays to evaluate editing processes and strategies.
- 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 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 Clinical Gene 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.
- The Scientist 1 will have trained to complete competency, with full team integration within 3 months. This is a key Technical Operations position ensuring technical execution, documentation, and real-time communication of Process Development activities to facilitate advancement of clinical candidates.
- This position reports to the Sr. Scientist of Process Development.
- Will have Lead responsibilities for Process Development team members.
- Will assist with onboarding and training of Process Development team members.
- Closely collaborates with colleagues within Technical Operations and other departments at Universal Cells and other Astellas sites.
- Operates on a normal Mon-Fri schedule, with occasional weekend shifts as required.
- 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.
- Experience with method and cellular assay development.
- Experience in mentoring/training junior researchers.
- 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 critical thinking 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 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.
- Experience with technical writing.
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