Quality & Analytical Development Lead – Cell Therapy

Lever, Inc.; Redwood City (CA); On-site; USD 230,000 - 280,000; Full time

Benefits offered by this job

Equity

Health benefits

401(k) matching

Flexible time off

Parental leave

Learning stipend

Longevity stipend

Lunch & snacks

Job summary

Retro is hiring to lead our Quality and Analytical Development team in Redwood City, CA. You will guide QA/QMS, analytical development, and CMC activities for cell-therapy programs and broader pipelines, reporting to the CEO.

You will partner with R&D, Process Development, Manufacturing, Regulatory, and Clinical to shape CQAs, control strategies, and critical parameters, while driving a robust QMS across cGMP operations.

Qualifications

• 8+ years of QA/QMS, QC, Analytical Development, or CMC experience.
• Experience taking cell-therapy programs through GMP manufacturing and clinical development.
• Experience building a phase-appropriate GMP Quality System.
• Hands-on expertise in one or more cell-therapy analytical areas (flow cytometry, potency and functional assays, molecular methods).
• Knowledge of cGMP, FDA cell-therapy guidance, ICH, 21 CFR Part 11, data integrity, and analytical validation.

Responsibilities

• Lead the Quality & Analytical Development team, setting priorities, coaching and developing the team, and building the group as needs evolve.
• Be accountable for the phase-appropriate QMS and independent Quality oversight supporting internal cGMP cell-therapy manufacturing.
• Partner with Program teams across R&D, Process Development, and Manufacturing, as well as Regulatory and Clinical, to define CQAs, control strategies, specifications, and critical process parameters.
• Guide analytical strategy and the full method lifecycle across our cell-therapy programs, from product characterization and method development through qualification and validation, transfer, QC implementation, and ongoing performance monitoring.
• Provide technical leadership across cell-therapy methods including flow cytometry, potency and functional assays, qPCR/ddPCR, ELISA, identity, purity/impurity, and viability testing.
• Oversee Quality review of GMP records, deviations, CAPAs, change controls, qualification/validation activities, batch documentation, and product disposition/release.
• Guide analytical investigations, troubleshooting, robustness, system suitability, critical reagent, and instrument-control strategies.
• Support regulatory strategy and submissions across analytical, CMC, Quality, potency, comparability, and control-strategy topics.
• Provide or coordinate Quality and analytical oversight for Retro’s small-molecule and gene-therapy programs as needed.
• Decide which capabilities should be built internally versus supported by consultants, CROs, CDMOs, or other external specialists.

Skills

8+ years exp

Cell-therapy

QA/QMS

QC

Analytical Development

CMC knowledge

Flow cytometry

Regulatory knowledge

Tools

qPCR/ddPCR

ELISA

Job description

Retro is hiring to lead our Quality and Analytical Development team in Redwood City, CA. You will guide QA/QMS, analytical development, and CMC activities for cell-therapy programs and broader pipelines, reporting to the CEO.

You will partner with R&D, Process Development, Manufacturing, Regulatory, and Clinical to shape CQAs, control strategies, and critical parameters, while driving a robust QMS across cGMP operations.