Lyell Immunopharma

Principal, Quality Control

Bothell, Washington, United States · Principal

Sponsorship not specified$148k-$185kDetected 5 days ago

Supply ChainGMPFDA RegulatoryPCRFlow CytometryMolecular BiologyLeadershipCommunicationAdaptabilityRegulatory Affairs

About the role

This role requires expertise in authoring CMC quality sections for IND and BLA regulatory submissions and serves as a key QC interface with Regulatory Affairs, QA, and Manufacturing during inspections and agency interactions.
Employees are also eligible to participate in Lyell's Equity Incentive Plan.

Serve as the QC analytical SME for the design, development, and validation strategy for cell therapy release and stability methods, including cell-based potency assays, flow cytometry-based phenotyping, and PCR-based methods (e.g., VCN, residual plasmid).
Lead method qualification or validation strategy in alignment with ICH Q2(R1)/Q2(R2), ICH Q6B.
Serve as QC SME during regulatory agency inspections, partner audits, and internal GMP audits related to analytical methods and testing strategies.
Drive continuous improvement initiatives within the QC laboratory, including method lifecycle management, assay robustness improvements, and test efficiency optimization.
Proven capability to design and oversee execution of qualification/validation protocols.
Ability to work effectively both independently and cross-functionally with Analytical Development, Manufacturing, MSAT, Regulatory, Supply Chain, and external partners to set goals, develop sound project plans, monitor progress, and report results.
Curious and proactive mindset with a continuous improvement orientation; actively seeks to understand processes, identify risks, and implement sustainable quality solutions.

The Principal, Quality Control is responsible for providing subject matter expertise (SME) in analytical method qualification, validation, and regulatory submission authoring for cell therapy products.
10-15 years of experience in GMP biopharmaceutical operations including 4 years in cell therapy and/or lentiviral manufacturing operations.

or MSc. in Biology, Immunology, Cell Biology, Biochemistry, Molecular Biology, or a related life sciences field with a minimum of 15 years' experience
Experience with MasterControl is a plus.

Expertise in cell therapy QC analytical methods, including flow cytometry, PCR-based assays, and cell-based functional/potency assays.
Comprehensive knowledge of ICH guidelines applicable to QC, including ICH Q2(R1)/Q2(R2), ICH Q6B, ICH Q1E, ICH Q9, and ICH Q14.
Strong working knowledge of GMP-regulated laboratory operations, GDP principles, and LIMS systems.
Outstanding communication, emotional intelligence and interpersonal skills.
Fast learner, adaptable, and has the desire and ability to work in a fast-paced, start-up environment.
Excellent analytical skills and scientific/technical expertise.

The salary range for this position is between $148,000 - $185,000, annually, with the opportunity to earn an annual bonus.

Direct experience supporting BLA submissions, regulatory filings, and/or health authority inspections.
Due to the nature of our autologous cell therapies and the need to deliver life-saving treatments to our patients as timely as possible, weekend work, and holiday work will occasionally be required.

We are looking for passionate team members to join our team that are willing to learn, grow, and evolve with us.
Part of this evolution will be to work together to continually assess and modify our shift structure to best support delivering these critical products to our patients.

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 d

This listing is sourced directly from Lyell Immunopharma's careers page and normalized into a canonical job model.