Senior Specialist, Cell Tracking, Scheduling and Forecasting System
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, Science, Collaboration and Courage and it reflects who we are and the environment we are creating.
You will be responsible for the Ocellos (Trakcel) and Binocs that support technical and clinical operations. This role supports the patient operations, supply chain, manufacturing and quality teams. You will provide strong experience and understanding of systems that support autologous cell therapy and both GxP and 21CFR part 11 regulations.
KEY ROLE AND 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 process libraries and workflows are up to date and accurate.
- 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 operations. This includes business continuity, off hours and on call support.
- Accountable for system administration activities.
- 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.
- BA/BSc in Statistics, Mathematics, Computer Science, Engineering or other close-related fields with a minimum of 7 years’ experience; or
- MBA or MSc in Statistics, Mathematics, Computer Science, Engineering or other close-related fields with a minimum of 4 years’ experience
- Minimum 5 years system experience in biotechnology or pharmaceutical industry, with vendor oversight experience.
- At least 3 years management experience including management of both budget and a technical team
- Autologous cell therapy experience highly preferred
- Experience with GxP and part 11 regulations
- Experience with Ocellos (Trakcel) and Binocs desired
- Experience with middleware platforms such as Mulesoft or Dell Boomi
KNOWLEDGE, SKILLS AND ABILITIES:
- Performed at least 1 (one) full life cycle implementation of Trakcel or Vineti platform preferred
- Managing small to medium scale projects
- Management of a full-service end-user technical support
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.