Using living cells to treat – and sometimes even cure – cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with hematologic malignancies and solid tumors, representing approximately 90% of all cancers. At Lyell, our goal is to change that. We are a clinical-stage T-cell reprogramming company advancing a diverse pipeline of cell therapies for hematologic malignancies and solid tumors based on our innovative technologies. We were founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer. In our quest to defeat cancer, we have built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. Our culture is based on Science, Respect, Collaboration, and Courage and reflects who we are, the environment we create, and our mission’s urgency.  This position will be based in our Seattle office.

POSITION SUMMARY:

You will be accountable for a diverse range of strategic and operational activities that advance cell therapy development, analytical development, and manufacturing. This role is a key member of the Technical Operations and CMC product development teams and will be responsible for building cell therapy processes, including analytical method development, within Lyell. 

KEY ROLE AND RESPONSIBILITIES:

• Assure cell therapy processes and analytics are characterized and optimized, and that lot release and characterization assays are compliantwith regulatory guidelines.
• Author and review sections of CMC regulatory submissions and represent the process sciences technical functions in regulatory interactions.
• Play a critical leadership role in developing the operating paradigm for Process Sciences; this role is responsible for developing and establishing how Lyell will develop and transfer all aspects of cell therapy development and technology to support commercialization.
• Serve as the technical and strategic expert in cell therapy development, including selection, activation, transduction, formulation, cryopreservation, and virus characterization method development for quantifying strength, purity, and potency attributes.
• Serve as the technical and strategic expert in cell therapy analytical development, including flow cytometry, cell biology, and molecular biology compendial and product-specific test methods.
• Lead the development and implementation of protocols and procedures related to cell and analytical process development operations.
• Establish robust cell and analytical standard processes that enable clinical product development and GMP operations.
• Collaborate and work with Research to support technology and product development.
• Work with key stakeholders to develop execution plans for reducing cycle times while increasing yields and productivity.
• Identify and mitigate risks in manufacturing operations that could negatively impact the quality of patient therapies.
• Demonstrate outstanding technical acumen, operational understanding, and GMP compliance in building and running process sciences.
• Champion implementation of new technologies and systems.
• Role model Lyell Values and Lean Leader principles to establish a continuous improvement culture.
• Collaborate with Research, Manufacturing, Quality, and Supply Chain leaders on all aspects of cell therapy technologies, analytical development, process development, and GMP production.

PREFERRED EDUCATION:

• MSc in biology or related scientific field with a minimum of 20 years’ experience or
• PhD in immunology, biology, oncology, or a related field with at least 20 years’ experience.

PREFERRED EXPERIENCE:

• Strong executive leadership experience in research, process development, and operations.
• Experience in GMP manufacturing, technology transfer, and implementation of new technologies in a regulated environment is preferred.
• Proven experience with assessing new technologies in a fast-paced, learning organization, preferably in a cross-functional setting where the impact of new technologies is evaluated across research, development, and commercial organizations.
• Strong scientific background and expertise in cell culture and virus products – prior experience in viral or cell therapy preferred
• Experience in developing and effectively managing department annual operating budgets.

KNOWLEDGE, SKILLS AND ABILITIES:

• Working knowledge of GMP regulations and experience interacting with regulatory agencies.
• Demonstrated ability to build effective and efficient teams, drive change, and motivate teams across multiple functions
  • Strong executive presence with the ability to lead executive discussions, focus on detail, and think strategically
  • Ability to drive Lean principles to increase productivity.
  • Knowledge and capability to develop a vision, strategy, and plans that are innovative, forward-thinking, and based on sound business judgment, taking into account scalability and sustainability.

At Lyell, we believe that the highest-performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse, and inclusive culture for all employees.

 

Lyell is proud to be an equal opportunity employer and does not discriminate based on race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.

 

Our Employee Benefits program is extensive and includes subsidized medical, dental, and vision plans from your first day of employment, FSA, Company provided Life and AD&D Insurance as well as STD and LTD Insurance, ESPP, a 401(k) Plan with Company match, mass transit commuter benefits, cell phone reimbursement and a range of supplemental benefits that you may choose to elect. Our paid time-off benefits currently include 18 days’ vacation, nine day’s sick leave, eight observed holidays as well as a floating holiday. We also have a summer and a winter office shutdown. More information on our extensive benefits offering can be found here.

 

We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply.