The incumbent is responsible for developing the incoming/final product and raw material receipt and disposition processes for the GMP Bothell Manufacturing Site. This role will work closely with the GMP Site Team to implement the electronic Manufacturing Execution System (MES) and specialize in the disposition processes. Once GMP Manufacturing operations are initiated, this individual will continue to perform routine Quality Assurance tasks including but not limited to batch record review, raw material disposition, deviation, CAPA, and change control approval, product change over, and other Quality Operations functions.
KEY ROLE AND RESPONSIBILITIES:
Startup GMP Facility and Operations
Execute the Day-to-Day Quality Assurance Operations
KNOWLEDGE, SKILLS AND ABILITIES:
Shift Work, Weekend Work and Holiday Coverage:
Due to the nature of our autologous cell therapies and the need to deliver life-saving treatments to our patients as timely as possible, shift work, weekend work and holiday work will be required.
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.