Associate Director, GMP Automation and Data

Location
Bothell, WA
Posted
Sep 22, 2020
Ref
20087
Required Education
Bachelors Degree
Position Type
Full time

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 Respect, Science, Courage and Collaboration and it reflects who we are and the environment we are creating.

Position Summary:

Lyell is building a state of the art immunotherapy manufacturing facility with an advance system automation and data integration to enable the production and delivery of our cell therapy to cancer patients!  We are recruiting a talented and experienced Director of GMP Systems and Data Management to assume a leadership position to design, implement, and operationalize our GMP Manufacturing and Supply Chain Systems.  The scope of systems include Manufacturing Execution Systems (MES), LIMS and ERP.  This role will be accountable for capability building (process, system, people, data) to enable the startup of our state of the art manufacturing facility.  Once the facility is commissioned, the Director of GMP Systems and Data Management will own the day to day operational aspects of running the integrated systems including but not limited to user training, issues management and resolutions, system upgrade, system integration, system change control, data management and continuous improvement.  

Our ideal candidate will have recent experience leading GMP system implementation and providing operational support to the shop floor, QC labs or supply chain teams.  Other Technical Operations functional experience such as Quality, Manufacturing, supply chain, engineering would be beneficial.  Experience in designing, implementing or managing manufacturing and supply chain systems such as ERP, MES, LIMS, Cell Tracking software is desired.  Successful candidates will be highly motivated, organized, and capable of building people, process and system capabilities that deliver high performing and sustainable results to serve our patients. We are seeking people who have demonstrated strong leadership, keep abreast of the latest technology advancements, communicate effectively and thrive in a highly collaborative, fast-paced startup environment.

Essential Functions:

  • GMP System design, implementation, validation and integration which will include lead the Business System Integration Team to prioritize system changes and improvement requests.   In addition, systems in scope include: MES, Historian, LIMS, ERP, Cell Tracking Systems
  • Master Data Management - Develop and deploy a monster data management process and Lifecycle Management.  Define policy, guidelines, operating procedure to support operations and ensure compliance.  Implement and chair data governance,  design and develop a companywide Master Data Management strategy plus design, implement and manage CMC and GMP data across Technical Operations.  Manage the on-boarding, loading and processing of GMP and non-GMP data into a robust cloud architecture
  • MES System management support which will include System ownership, 24/7 system support to Manufacturing shop floor, System change control and management, User training, Software upgrade, Interface with IT, system vendors, operational team
  • LIMS System management and support to include System ownership, real-time system support to QC and PD team, System change management, Software upgrade
  • ERP System System ownership, real-time system support to Supply Chain and Manufacturing team, System change management, Software upgrade
  • Cell Tracking Software which includes system ownership, real-time system support to Supply Chain, MFG and Clinical Operations, system change management, Software upgrade
  • Performance Management - Identify risks and implement risks mitigation plan including systems and data backup and recovery plan to ensure business continuity and accountable for defining and reporting GMP Integrated system health Performance Management.  Proactively identify, develop, and implement reporting and analytics to support the monitoring of overall system health performance.  Measure, trend and report supply related KPI’s as a basis to drive continuous improvement

Minimum Requirements:

  • Biotechnology or Cell Therapy manufacturing MES and LIMS system automation experience 
  • Engineering Degree in system, mechanical, electrical, process automation
  • Recent experience leading implementation of MES, LIMS, or ERP
  • 15 years of experience in a regulated cGMP environment; experience with cloud solutions
  • Master's degree in related discipline preferred

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.