Quality & Analytical Lead – Cell Therapy

Retro Fitness; Redwood City (CA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) plan with 4% matching

Flexible time off and 10 holidays

Paid parental and medical leave

Learning and development stipend

Longevity stipend

Daily company lunch and snacks

Job summary

Retro Therapeutics seeks a seasoned leader to head Quality & Analytical Development, driving the QA/QMS culture for cGMP cell-therapy manufacturing. You will shape CQAs, control strategies, and analytical methods while coordinating with R&D, Process Development, Manufacturing, Regulatory, and Clinical teams.

You bring hands-on expertise in cell-therapy analytics (flow cytometry, potency, qPCR/ddPCR, ELISA) and build a scalable quality system aligned with speed and accuracy goals.

Qualifications

• 8+ years of QA/QMS, QC, Analytical Development, or CMC experience.

Responsibilities

• Lead Quality & Analytical Development team and guide the group through growth.
• Own phase-appropriate QMS and independent Quality oversight for internal cGMP manufacturing.
• Define CQAs, control strategies, specs, and critical process parameters with cross-functional teams.
• Guide analytical strategy and lifecycle from method development to transfer and QC implementation.
• Provide leadership across cell-therapy methods including flow cytometry, potency assays, and molecular methods.
• Oversee GMP records review, deviations, CAPAs, change controls, and product disposition.

Skills

QA/QMS

GMP

Cell therapy analytics

Leadership

Regulatory strategy

cGMP

CQAs

Process development

Tools

Flow cytometry

qPCR/ddPCR

ELISA

Job description

Retro Therapeutics seeks a seasoned leader to head Quality & Analytical Development, driving the QA/QMS culture for cGMP cell-therapy manufacturing. You will shape CQAs, control strategies, and analytical methods while coordinating with R&D, Process Development, Manufacturing, Regulatory, and Clinical teams.

You bring hands-on expertise in cell-therapy analytics (flow cytometry, potency, qPCR/ddPCR, ELISA) and build a scalable quality system aligned with speed and accuracy goals.