Associate II, Quality Assurance

Lyell Immunopharma•Bothell, WA

4d•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. Lyell is 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 stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response. The company was founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer. In its quest to advance next-generation CAR T-cell therapies, Lyell has built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. The company's culture is based on Science, Respect, Collaboration, and Courage and reflects who they are, the environment they create, and their mission's urgency. The Quality Assurance team is seeking a highly motivated and detail-oriented Quality Assurance Associate II to join the team at the Lyell Manufacturing Facility, LyFE in Bothell WA. This individual will perform routine Quality Assurance tasks including but not limited to batch record review, raw material disposition, deviation investigation, CAPA, and change control approval, GMP cleanroom support and other Quality Operations functions.

Requirements

Experience with electronic quality management systems (e.g. deviations, CAPAs, change management) required.
Ability to work effectively both independently and with a team to set goals, develop sound project plans, monitor progress, and report results.
Excellent communication, emotional intelligence and interpersonal skills.
Motivated and organized critical thinker with solid cross-collaboration and business communication skills.
Fast learner, adaptable, with creative problem-solving skills.
Ability to work efficiently, prioritize workflow, meet deadlines and balance competing.
The desire and ability to work in a fast-paced, start-up.
Excellent analytical skills and scientific/technical.

Nice To Haves

AA/BA or BSc degree or an equivalent combination of education and work experience
3+ years of cGMP experience in GMP biopharmaceutical operations and with prior experience in a GMP Quality role.
Experience in clinical
Proficiency using multiple digital GMP Platforms
Familiarity with Cellular Therapy manufacturing
Familiarity with Lentiviral Vector manufacturing

Responsibilities

Perform review and approval of executed electronic batch records, and resolution of discrepancies with manufacturing personnel.
Perform review and approval of Deviation, Excursion and CAPA record.
Provide quality support for manufacturing operations in the cleanroom facilities (e.g. intake of incoming patient apheresis material, product pack-out, event triage).
Be a quality point of contact for process support escalations, troubleshooting, triage and resolution.
Perform review and disposition of incoming raw materials, and approval of raw material.
Review and approve executed test results, perform review tasks in the laboratory information management system to issue Certificates of Analysis (COAs) as applicable.
Author and/or collaborate on the creation, revision, and obsoletion of Standard Operating Procedures across the LyFE site.
Perform review and approval of asset induction/release deliverables, on-demand work, and non-conformances.
Support other routine Quality operations as required, commensurate with experience and the LyFE site maturation.
Represent Quality Assurance on project specific teams.
Promote a culture of safety and GMP compliance.
Identify opportunities for continuous improvement.
Perform internal audits.
Support operational excellence initiatives.