Senior Associate, Quality Assurance

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, Change 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
• Proficiency using multiple digital GMP Platforms
• 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.
• Able 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.

Qualifications

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

About the Role

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.

Requirements

• 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.
• Able 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.