Manager, Cell Tracking, Scheduling and Forecasting System

Lyell Immunopharma • Bothell, WA

8h • $150,000 - $180,000

About The Position

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 solid tumors, representing approximately 90% of all cancers. And for patients with hematologic malignancies, there is a need for next-generation cell therapies that can deliver increased response rates and longer duration of response. We are a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. Lyell’s product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response. 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 advance next-generation CAR T-cell therapies, 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.
POSITION SUMMARY:
The incumbent is responsible for Ocellos (Trakcel) and Binocs applications that support technical and clinical operations. This role supports patient operations, supply chain, manufacturing and quality teams. The incumbent provides strong experience and understanding of systems that support autologous cell therapy and both GxP and 21CFR part 11 regulations.

Requirements

• BA/BSc in Statistics, Mathematics, Computer Science, Engineering or other close-related fields with a minimum of 10 years’ experience; or
• MBA or MSc in Statistics, Mathematics, Computer Science, Engineering or other close-related fields with a minimum of 7 years’ experience
• Minimum 5 years system experience in biotechnology or pharmaceutical industry, with vendor oversight experience.
• At least 5 years management experience including management of both budget and a technical team
• Experience with GxP and part 11 regulations
• Managing small to medium scale projects
• Establishing strong relationships with cross functional partners
• Management of a full-service technical support

Nice To Haves

• Autologous cell therapy experience highly preferred
• Experience with Ocellos (Trakcel) and Binocs desire
• Experience with middleware platforms such as Mulesoft or Dell Boomi
• Performed at least 1 (one) full life cycle implementation of Trakcel or Vineti platform preferred

Responsibilities

• Responsible for the overall budget and management of projects and functionality that support cell therapy patient operations, including systems Ocellos (Trakcel) and Binocs (scheduler)
• Collaborate with clinical operations, patient operations, supply chain, manufacturing and quality to ensure their business needs are planned for, communicated and met.
• Own cell tracking and scheduling roadmap with alignment across technical operations and clinical operations.
• Ensure Binocs services and workflows are up to date and accurate by owning the configuration and leveraging vendor manages services.
• Establish and nurture vendor relationship with Trakcel. (Status quo on operating model should be challenged and improved)
• Deliver and maintain systems in compliance with GMP and GCP requirements
• Responsible for the interfaces between Cell Tracking and Scheduling systems to other GMP systems to support operations.
• Manage system support programs to support clinical and technical This includes business continuity, off hours and on call support.
• Accountable for system administration
• Maintain system life cycle documents including user requirements, functional technical specifications, and configuration specifications.
• Responsible for executing validation testing including installation, operational and performance qualifications.

Benefits

• Lyell offers its employees a range of compensation and benefits.
• The salary range for this position is $150,000 to $180,000, 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 251-500 employees