Senior Quality Control Associate, Cell Biology

Location
98011, Bothell
Posted
Sep 03, 2020
Ref
20061
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 Science, Respect, Courage and Collaboration and it reflects who we are and the environment we are creating.

The Senior QC Associate Cell Biology will primarily be responsible for performing QC release testing of immunotherapy products, with a focus on cell-based test methods. The position is in a regulated environment following current Good Manufacturing Practices (cGMPs) and Good Documentation Practices (GDPs). This role will partner closely with the Analytical Development (AD) and Manufacturing teams for testing and releasing drug product.

Essential Functions:

• Provide support in setting up the Cell Biology Lab
• Perform routine in process and release testing of cell therapy products
• Work cross-functionally with AD in the transfer and validation of the cell-based test methods
• Participate in writing and review of test methods and supporting Standard Operating Procedures (SOPs) for the QC Laboratories
• Maintain critical reagents inventory and qualification for QC labs
• Performing routine preventative maintenance on QC equipment

REQUIREMENTS:

Experience:

• A minimum of 4 years of cell-based testing within a regulated cGMP environment
• Quality systems experience in managing deviations, CAPAs is a plus

Education:

• BA or BS degree in a relevant field (e.g. Immunology, Cell Biology) is preferred

Additional Skills:

• Good Documentation Practices (GDP) and ALCOA required
• Good organizational and time management skills
• Good oral and written communication for effective interpersonal collaboration
• Ability to work in a team environment and perform job responsibilities with reasonable supervision
• Exceptional attention to detail
• Identify opportunities for operational excellence, application of Lean principles and continuous improvement
• Must be proactive, action oriented and have the ability to adapt to a change

 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.