Astellas Pharma Associate Director/Director, Immune Cell Manufacturing 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 (UCells) is announcing an Associate Director/Director, Immune Cell Manufacturing opportunity at their facility in Seattle, WA.
The Director/Assoc. Director of Immune Cell Manufacturing will be responsible for the implementation of immune cell manufacturing for the Universal Cells cell therapy development programs. This position will provide subject matter expertise and insight into the development, differentiation, and scale-up of Natural Killer (NK) cells or other immune cells manufacturing, related to universal donor NK or other immune cells derived from pluripotent stem cells. This position will develop and ensure timelines and quality standards are met; will play an integral role in troubleshooting technical production issues; inspire and develop team members to excel; and will be accountable for meeting deliverables for immune cells manufacturing programs.
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:
- Creates a strategic and tactical plan for cell manufacturing in coordination with Universal Cells Research teams.
- Demonstrates a thorough knowledge of process development and manufacturing for cell therapy production.
- Executes process optimization, scale up and tech transfer as needed to Astellas affiliate locations for future growth and GMP production.
- Prepare/review technical documents including development /tech transfer reports, process characterization reports, batch records, SOPs and CMC regulatory submissions.
- Facilitates technical transfer proactively with detailed process/analysis development function and scale up to manufacturing with required level of GMP and stability.
- Exercises technical discretion in the design, execution and interpretation of experiments that contribute to project goals.
- Makes detailed observations, analyzes data and interprets results.
- Prepares technical reports, summaries, protocols, and quantitative analyses.
- Presents progress to UCells Leadership team and at Research group meetings.
- Proactively identifies operational risks related to cell manufacturing and works with the team to develop contingency plans.
- Aligns priorities across functional groups and external contractors / consultants.
- Performs research and/or development in collaboration with other Research teams.
- May conduct hands-on experimentation as needed.
- Participates in relevant partnership activities and scientific meetings as indicated.
- Perform other duties as assigned or special projects as needed
- BS/BA degree (or equivalent) in a relevant scientific field required, with a Master's or PhD in life sciences strongly preferred.
- Demonstrated hands-on experience with immune cell manufacturing.
- 10+ years of experience in roles in the biotech and/or pharmaceutical industry, with specific experience related to process development and/or manufacturing scale-up, knowledge of biologic manufacturing processes, GMP principles, and related FDA and other regulatory guidelines.
- 3-5 years of experience in management/leadership roles in a matrix environment, with demonstrated leadership skills and strategic thinking.
- Excellent scientific writing and editing as well as written/oral communication skills.
- Demonstrated industry experience or academic achievement, as evidenced by drug development portfolio or publications in high impact journals.
- Ability to thrive and flourish in an entrepreneurial early stage company environment that requires "hands-on" implementation, optimal use of limited resources and an ability to work closely with others in a small team setting.
- Exerts influence in the development of overall objectives and long-range goals of the organization.
- Strong time-management and organizational skills coupled with a sense of urgency and strong work ethic.
- Must have critical thinking skills, robust technical writing skills, strong scientific skills, good interpersonal communication skills.
- Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- Collaborative team player who has the ability to think and act quickly; identify creative solutions to complex problems, communicate and act quickly to the benefit of the team and meeting objectives.
- Ability to foster a culture of innovation while adhering to compliance and regulatory needs.
- Strong attention to detail with the ability to articulate quality related risks and potential impact.
- Proficient knowledge of MS Word, Excel, PowerPoint & Outlook.
- Conceptual knowledge of innate and adaptive immune cells and immunomodulatory cytokines.
- Hands-on experience in differentiation of immune cells such as lymphocytes/NK cells from pluripotent stem cells or progenitor cells and culture.
- Experience with human or mouse pluripotent stem cell manipulation.
- Experience managing projects and teams highly preferred
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled Category Research and Development