Sr. Associate Quality Assurance - Contract role

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. 

Location: Lyell Manufacturing Facility– Bothell, WA
Work Schedule: Onsite only (no remote option)

Shift Options:
• Wednesday–Saturday (10 hours/day)
or
• Sunday–Wednesday (10 hours/day)

Position Summary:
The Quality Assurance (QA) team is seeking a highly motivated and detail-oriented Senior Associate, Quality Assurance for a Contract, full time position to support operations at Lyell’s manufacturing facility in Bothell, WA. This role is responsible for executing routine QA functions in support of GMP manufacturing operations, including batch record review, raw material disposition, deviation investigations, CAPA support, and change control approval. The position plays a key role in maintaining compliance, supporting production workflows, and ensuring product quality and safety. The duration of the assignment will depend upon the business needs.

Key Responsibilities:

Execute Day-to-Day Quality Assurance Activities Supporting Manufacturing:
• Review and approve executed electronic batch record comments and resolve discrepancies with manufacturing personnel
• Review and approve executed test results; perform LIMS review tasks and issue Certificates of Analysis (COAs) as applicable
• Provide quality support for cleanroom manufacturing operations
• Serve as a QA point of contact for escalations, troubleshooting, triage, and issue resolution
• Perform routine hands-on QA activities including intake of incoming patient apheresis and drug product pack-out activities
• Compile, review, and approve lot disposition records
• Perform routine raw material disposition and approve specifications
• Review and approve Deviations, Change Controls, CAPAs, Excursions, and Nonconformance records
• Promote a strong culture of safety and GMP compliance
• Identify and support continuous improvement initiatives
• Support complex change controls (as applicable)
• Support process and/or method qualification and validation activities through QA review of protocols, data, and reports
• Perform internal audits (as applicable)
• Support operational excellence initiatives

Knowledge, Skills & Abilities:
• Experience supporting clinical and cGMP manufacturing environments required
• Experience using electronic Quality Management Systems (QMS) (deviations, CAPAs, change management)
• Ability to work independently and collaboratively across teams
• Strong communication, emotional intelligence, and interpersonal skills
• Organized, detail-oriented critical thinker with strong cross-functional collaboration ability
• Adaptable and comfortable working in a fast-paced startup-style environment
• Strong analytical and technical/scientific problem-solving skills
• Ability to prioritize multiple workflows and meet deadlines efficiently

Preferred Education:
• Bachelor’s degree in Biochemistry, Chemical Engineering, Bioengineering, or related scientific discipline
• 7+ years relevant experience

Preferred Experience:
• 4–6+ years in GMP biopharmaceutical operations
• Minimum 2+ years in GMP Quality
• Experience using multiple digital GMP platforms
• Familiarity with Cellular Therapy manufacturing
• Familiarity with Lentiviral Vector manufacturing

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.

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 flexible time off,  8 observed holidays as well as a floating holiday. We also have a winter office shutdown.