KEY ROLE AND RESPONSIBILITIES: 

• Create, manage, and maintain controlled manuals that describe the process for apheresis collection and final drug product administration. 
• Ensure right first-time apheresis 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. 
• Manage Lyell healthy donor apheresis suppliers. 
• Own any CAPAs or Deviations related to improper handling of patient cells.
• Work collaboratively and partner with Manufacturing, Quality, Clinical Operations, CMC, 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 of clinical site dry runs to ensure appropriate communication with the manufacturing teams. 
• Establish electronic tools, processes, and procedures to support the Patient cell operations team. 

 

PREFERRED EDUCATION & EXPERIENCE: 

• Bachelor’s Degree and 3+ years relevant work experience; or sufficient work experience in related field for 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 
• Experiencing 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) 

 

Lyell offers its employees a range of compensation and benefits. To assist you with your decision to apply for this role, the following decision to apply for this role, the following information and links to our site highlight our competitive market position and support to our employees and their dependents.

 

The salary range for this position is $140k to 165k annually, with the opportunity to earn an annual bonus. The salary range is an estimate, and the actual salary may vary based on Lyell’s compensation practices and an applicant’s qualifications and experience. Employees are also eligible to participate in Lyell’s Equity Incentive Plan.

 

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, 9 day’s sick leave, 8 observed holidays as well as a floating holiday. We also have a summer and a winter office shutdown.

 

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.

 

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.