Quality Control Manager

Lyell Immunopharma•Bothell, WA

4d•Onsite

About The Position

Lyell is a clinical-stage company developing next-generation CAR T-cell therapies for patients with solid tumors and hematologic malignancies. The company is seeking a Quality Control Manager – Cell Therapy for its Lyell Manufacturing Facility (LyFE) in Bothell, Washington. This onsite role leads Quality Control operations supporting GMP manufacturing, cell therapy product release, and analytical method transfer. The manager oversees analytical testing and data review, environmental monitoring, laboratory compliance and data integrity, and method lifecycle management to help ensure products meet regulatory, safety, and quality standards. The role supports clinical and commercial manufacturing and ensures compliance with cGMP, regulatory guidance, and internal quality systems. The position requires experience in a GMP-regulated facility and a strong technical foundation in one or more release-testing areas, including cell-based potency, flow cytometry, or PCR-based assays. It also involves managing and developing QC staff, coordinating laboratory operations, partnering with cross-functional teams, and supporting regulatory filings, inspections, and audits. This is an onsite position with no remote option. Occasional weekend and holiday work is required, and shift structures may evolve to support product delivery. Candidates must be authorized to work in the United States without sponsorship.

Requirements

At least 8 years of experience in a GMP-regulated pharmaceutical, biotechnology, or related industry.
Prior experience in cell therapy environments.
At least 10 years of experience in cGMP biopharmaceutical manufacturing, including 5 or more years in cell therapy.
A BSc with at least 10 years of relevant experience, or an MSc with at least 7 years of relevant experience; relevant fields include Cell Biology, Immunology, or Flow Cytometry.
At least 5 years of people-management experience in technical GMP roles.
Solid technical understanding of cell therapy release-testing assays.
Proven ability to manage competing priorities and lead a team in a fast-paced, time-critical GMP environment.
Strong leadership and team development skills.
Excellent analytical and problem-solving abilities.
Experience with electronic systems such as LIMS, ELN, or electronic batch records.
Experience with method validation and regulatory submissions.
Familiarity with FDA regulatory expectations for advanced therapy medicinal products (ATMPs).
Authorization to work in the United States without sponsorship.
Willingness to work occasional weekends and holidays.

Nice To Haves

Experience with BMRAM.
Experience with MasterControl.

Responsibilities

Schedule day-to-day QC laboratory operations supporting release and in-process testing of cell therapy products.
Oversee the lifecycle of analytical assays, including flow cytometry, digital droplet PCR, sterility, endotoxin, mycoplasma, cell viability, vector copy number, and potency assays.
Review data to support issuance of drug product Certificates of Analysis.
Manage the manufacturing site's Contamination Control Program.
Ensure timely testing and release of raw materials and drug product.
Support analytical method transfer, qualification, validation, and lifecycle management.
Manage, mentor, and develop QC analysts and supervisors.
Establish staffing plans and training programs to support laboratory operations.
Review and approve analytical records, Certificates of Analysis, and laboratory documentation.
Ensure proper maintenance and qualification of laboratory equipment.
Oversee stability testing programs.
Partner with Manufacturing, QA, Regulatory, Process and Analytical Development, Manufacturing Sciences and Technology, and Supply Chain to support product release and continuous improvement.
Initiate, lead, and participate in deviations, Change Controls, and CAPAs.
Author and review regulatory filings and support licensing inspections and client audits.