Quality & Analytical Development Lead for iPSC Cell Therapy

Retro Biosciences; Redwood City (CA); On-site; USD 230,000 - 280,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) plan with matching

Generous paid time off

Parental and medical leave

Learning & development stipend

Longevity stipend

Company lunches

Job summary

Retro Biosciences in Redwood City is seeking a senior leader to build and guide the Quality & Analytical Development unit. You will shape the quality culture for internal cGMP manufacturing of iPSC-derived cell therapies, bringing regulatory and industry perspective to the team and broader pipeline.

The role is hands-on and cross-functional, partnering with R&D, Process Development, Manufacturing, Regulatory and Clinical teams to define CQAs, control strategies, specs, and process parameters.

Qualifications

• 8+ years of experience in QA/QMS, QC, Analytical Development, and/or CMC for cell-therapy programs.
• Experience taking cell-therapy programs through GMP manufacturing to clinic.
• Solid knowledge of cGMP, FDA guidance, ICH, 21 CFR Part 11, and data integrity.

Responsibilities

• Lead Quality & Analytical Development team, setting priorities and coaching staff.
• Oversee phase-appropriate QMS and independent Quality oversight for internal cGMP manufacturing.
• Define CQAs, control strategies, specs, and critical process parameters with cross-functional partners.
• Guide analytical strategy and full method lifecycle from development to release and monitoring.
• Provide leadership across cell-therapy methods including flow cytometry, potency assays, and molecular tests.
• Oversee GMP record reviews, deviations, CAPAs, change controls, and batch documentation.

Skills

Quality Assurance

GMP

Analytical Development

Cell Therapy

QA/QMS

Tools

Flow cytometry

qPCR/ddPCR

Method development

Job description

Retro Biosciences in Redwood City is seeking a senior leader to build and guide the Quality & Analytical Development unit. You will shape the quality culture for internal cGMP manufacturing of iPSC-derived cell therapies, bringing regulatory and industry perspective to the team and broader pipeline.

The role is hands-on and cross-functional, partnering with R&D, Process Development, Manufacturing, Regulatory and Clinical teams to define CQAs, control strategies, specs, and process parameters.