Senior Quality Assurance Associate

Lyell Immunopharma; Bothell (WA); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Equity Incentive Plan

Job summary

Lyell Immunopharma in Bothell, WA, is seeking a Quality Assurance Senior Associate to join the LyFE manufacturing facility onsite Sunday through Wednesday, 10 hours per day. You will perform batch-record reviews, COA issuance, material disposition, deviation investigations, CAPA and change control, and other QA tasks to sustain manufacturing quality in the cleanroom.

Ideal candidates hold a BS in biochemistry/related field with 4–6+ years in GMP biopharma, plus 2+ years in GMP quality, plus

Qualifications

• BS degree with 7+ years in a relevant field (e.g. biochemistry, chemical engineering, bioengineering, or related scientific field)
• 4-6+ years of experience in GMP biopharmaceutical operations with a minimum of 2+ years in GMP quality
• Experience with cellular therapy manufacturing and lentiviral vector manufacturing

Responsibilities

• Review and approve executed electronic batch records and resolve discrepancies with manufacturing personnel
• Review and approve test results and issue COAs as applicable in the LIMS
• Provide quality support for manufacturing operations in cleanroom facilities
• Be a quality contact for process support escalations, troubleshooting, triage and resolution
• Perform routine QA activities such as intake of patient apheresis and drug product pack-out
• Compile, review and approve lot disposition records
• Perform routine raw material disposition and approve material specifications
• Review and approve Deviation, Change Control, CAPA, Excursion and Nonconformance records
• Promote safety and GMP compliance; identify opportunities for continuous improvement
• Support Process/Method Qualification and Validation activities with quality review of protocols and data
• Perform internal audits as required; support operational excellence initiatives

Skills

Quality Assurance

cGMP

Communication

Project planning

Cross-functional collaboration

Education

BS degree in biochemistry/related field

Tools

eQMS

Job description

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 team is seeking a highly motivated and detail-oriented Quality Assurance Senior Associate to join our 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, and other Quality Operations functions. This role requires working a Sunday through Wednesday shift, 10 hours per day, and is an onsite role with no remote work option.

KEY RESPONSIBILITIES:

• Execute the Day-to-Day Quality Assurance Tasks to Support Ongoing Manufacturing:
• Review and approve executed electronic batch record comments and resolve discrepancies with manufacturing personnel.
• Review and approve executed test results, perform review tasks in the laboratory information management system to issue Certificates of Analysis (COAs) as applicable.
• Provide quality support for manufacturing operations in the cleanroom facilities
• Be a quality point of contact for process support escalations, troubleshooting, triage and resolution.
• Perform routine hands-on QA activities such as 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 raw material specifications.
• Perform review and approval of Deviation, Chage Control, CAPA, Excursion and Nonconformance record deliverables, as applicable.
• Promote a culture of safety and GMP compliance.
• Identify opportunities for continuous improvement.
• Support Process and/or Method Qualification and Validation activities by providing quality review of associated protocols, data and reports.
• Perform internal audits as required.
• Support operational excellence initiatives.

PREFERRED EDUCATION:

• BS degree with 7+ years experience in a relevant field (e.g. biochemistry, chemical engineering, bioengineering, or related scientific field)

PREFERRED EXPERIENCE:

• 4-6+ years of experience in GMP biopharmaceutical operations with a minimum of 2+ years in GMP quality
• Familiarity with Cellular Therapy manufacturing
• Familiarity with Lentiviral Vector manufacturing

KNOWLEDGE, SKILLS AND ABILITIES:

• Experience in clinical and cGMP manufacturing required.
• 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 priorities.
• The desire and ability to work in a fast-paced, start-up environment.
• Excellent analytical skills and scientific/technical expertise.
• This role requires working a Sunday through Wednesday shift, 10 hours per day, and is an onsite role with no remote work option.

The salary range for this position is $75,000 to $95,000 per year, with the opportunity to earn an annual bonus. The salary range is an estimate, and the actual salary may vary based on Lyell’s compensation practices and an applicant’s qualifications and experience.

• Employees are also eligible to participate in Lyell’s Equity Incentive Plan.

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.