Sr. Associate Quality Assurance - Contract role

Lyell Immunopharma•Bothell, WA

1d•Onsite

About The Position

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. 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.

Requirements

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
Bachelor’s degree in Biochemistry, Chemical Engineering, Bioengineering, or related scientific discipline
7+ years relevant experience
4–6+ years in GMP biopharmaceutical operations
Minimum 2+ years in GMP Quality

Nice To Haves

Experience using multiple digital GMP platforms
Familiarity with Cellular Therapy manufacturing
Familiarity with Lentiviral Vector manufacturing

Responsibilities

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