Manager, Patient Cell Operations
At Lyell, our vision is to develop curative cell-based immunotherapies for solid tumor cancers. We have innovative science originating from our founder’s world class labs and a unique and disruptive approach to research and development. Our company is first and foremost focused on understanding the science. We are a learning organization, dependent on deep collaborative relationships between all of our colleagues, partners and founders. Our culture is based on Science, Respect, Collaboration and Courage and it reflects who we are and the environment we are creating.
You will manage all operations regarding the collection and management of patient cells during the cell therapy process. This cross-functional role will work with manufacturing, clinical operations, quality, CMC and external clinical sites to ensure right first-time management of patient cells (apheresis, tissue, and final drug product) related to the manufacturing process.
KEY ROLE AND RESPONSIBILITIES:
- Create, manage, and maintain controlled manuals that describe the process for apheresis collection, tissue collection, and final drug product administration.
- Ensure right first-time apheresis, tissue collections, and final drug product handling at the clinical sites and apheresis centers.
- Establish and maintain training material related to the Patient Cell Operations controlled manuals.
- Ensure any persons at the clinical site and apheresis center managing Patient Cells are appropriately trained.
- Own any CAPAs or Deviations related to improper handling of patient cells.
- Work collaboratively and partner with Manufacturing, Quality, Clinical Operations, Research and Development, and with any Lyell partners or contracted organizations/services.
- Ensure appropriate materials or shipping containers required for handling Patient Cells during collection or final drug product are validated.
- Responsible for managing the forecast, allocation, and manufacturing slots available to schedule into.
- Establish electronic tools, processes, and procedures to support the Patient cell Operations team.
- BA/BSc in biology, biochemistry, chemical engineering, bioengineering, or related scientific field with a minimum of 10 years’ experience; or
- MBA or MSc in biology, biochemistry, chemical engineering, bioengineering, or related scientific field with a minimum of 8 years’ experience.
- Minimum of 7 years’ Cell Therapy experience in patient cell operations or apheresis operations.
- Clinical/Nursing experience related to apheresis, tissue collections, and/or infusions.
- Experience managing cross functional relationships with several different teams internally in the company and externally.
- Experience working and creating documents in a GxP environment.
- Experience creating training material and training people in a GxP environment.
- Experience in managing a team.
- Experience as a strong collaborator, effective at influencing internally and externally, and proactive in a fast-paced environment.
KNOWLEDGE, SKILLS AND ABILITIES:
- Knowledge of Patient Cell Operations related to cell therapy patients on clinical trials.
- Knowledge of medical terminology and the clinical trial management process.
- Ability to present and train others in a virtual or in-person setting.
- Exceptional written, communication, and organization skills.
- Highly self-motivated with demonstrated ability to work independently.
- Excellent organizational, multi-tasking and time management skills.
- Knowledge of FDA regulations and the regulations and guidelines applicable to life sciences organizations (GxP).
At Lyell, we believe that 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 on the basis of 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.
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company’s facilities and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.”
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.