Head of Quality & Analytical Development - Cell Therapy

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

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with matching

Flexible time off & holidays

Parental and medical leave

Learning stipend

Longevity stipend

Lunch program

Job summary

Retro is seeking a leader to head Quality & Analytical Development, guiding phase-appropriate QMS, securing GMP readiness for in-house manufacturing, and coordinating with Regulatory and Clinical teams. You will shape quality culture, oversee CGMP practices, and steer analytical methods from development through validation for multiple programs.

The role requires hands-on leadership, deep GMP knowledge, and the ability to balance speed with accuracy in a startup environment focused on aging

Qualifications

• 8+ years of relevant experience in GMP Quality systems and cell-therapy Analytical Development and/or QC
• Experience taking cell-therapy programs through GMP manufacturing and clinical development
• Ownership of Quality processes and decision-making related to deviations, CAPAs, change controls, audits, vendor qualification, or GMP documentation and approvals
• Experience transitioning analytical methods from development into GMP QC, including qualification/validation and method transfer

Responsibilities

• Lead Retro’s Quality & Analytical Development team, setting priorities, coaching and developing the team
• Be accountable for the phase-appropriate QMS and independent Quality oversight supporting internal cGMP cell-therapy manufacturing
• Lead GMP manufacturing Quality readiness, including facility and equipment qualification oversight, vendor qualification, audits, and implementation of Quality controls
• Partner with Program teams to define CQAs, control strategies, specifications, and critical process parameters
• Guide analytical strategy and the full method lifecycle across cell-therapy programs, from characterization and development through qualification and validation
• Provide technical leadership in bringing cell-therapy analytical methods into GMP QC, including flow cytometry and qPCR/ddPCR
• 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, 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 by external partners

Skills

GMP Quality Systems

Cell-therapy Analytical Development

QA Decision-Making

Process & Compliance

Tools

Flow Cytometry

qPCR/ddPCR

Job description

Retro is seeking a leader to head Quality & Analytical Development, guiding phase-appropriate QMS, securing GMP readiness for in-house manufacturing, and coordinating with Regulatory and Clinical teams. You will shape quality culture, oversee CGMP practices, and steer analytical methods from development through validation for multiple programs.

The role requires hands-on leadership, deep GMP knowledge, and the ability to balance speed with accuracy in a startup environment focused on aging