Head of Quality, Cell Therapy

Job description

Retro develops therapies for diseases driven by the biology of aging. We focus on cellular reprogramming and autophagy to rejuvenate cell and tissue function with the ultimate aim of adding 10 years to healthy human lifespan. We’re building a mission-driven team of accomplished and kind individuals who embrace our startup culture of rapid iteration, transparency, and versatility. We are currently hiring someone to **lead our Quality and Analytical Development team** and to continue to shape the quality culture at Retro. ### About the role: In this position, you will work hands-on with the team and bring the experience and perspective of having previously taken cell-therapy programs through GMP manufacturing and into the clinic. Your primary focus will be preparing our iPSC-derived cell therapy programs for clinical manufacturing. You will lead the continued buildout of our Quality Unit and phase-appropriate GMP Quality systems, ensuring our in-house manufacturing facility, processes, and external partners are ready to support clinical production. You will also guide our Analytical Development and QC team as they take methods from development through qualification and into routine GMP testing, bringing the technical judgment and regulatory perspective needed to establish appropriate controls and make sound Quality decisions. You will provide Quality and analytical oversight across Retro's broader pipeline, including small-molecule and gene-therapy programs, and report directly to the CEO. ### About you: You’re a first-principles thinker who believes in building the simplest, most effective team and systems for each phase of development. You’ve seen Quality done in different ways and can separate true best practices from unnecessary processes, bringing the right pieces together for Retro while embracing our tenet of Speed × Accuracy. You know when to flex, when to hold the line, and how to keep patient safety at the center of those decisions. You’re comfortable moving between technical details, Quality decisions, and broader program strategy, while staying directly involved with the work. You’re optimistic about our ability to positively impact the human condition and extend healthy human lifespan. ### In this role you will: - Lead Retro’s 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. - Lead GMP manufacturing Quality readiness, including facility and equipment qualification oversight, vendor qualification, audits, and the implementation of critical Quality controls. - 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 in bringing cell-therapy analytical methods into GMP QC, particularly flow cytometry and qPCR/ddPCR, with an understanding of method performance, qualification, sensitivity, precision, and statistically justified acceptance criteria. - 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. ### You might thrive in this role if you: - Have 8+ years of relevant experience, including substantial experience in GMP Quality systems and cell-therapy Analytical Development and/or QC, with the technical and operational breadth to oversee all three functions. - Have taken cell-therapy programs through GMP manufacturing and clinical development. - Have firsthand experience implementing and operating GMP Quality systems, including ownership of Quality processes and decision-making related to deviations, CAPAs, change controls, audits, vendor qualification, or GMP documentation and approvals. - Have led the transition of cell-therapy analytical methods from development into GMP QC, including phase-appropriate qualification or validation, method transfer, and implementation for release and stability testing. - Bring deep hands-on expertise in one or more cell-therapy analytical areas, such as flow cytometry, potency and functional assays, or molecular methods, and enough breadth to coach the team and make sound technical decisions across the broader analytical program. - Have experience with batch review, disposition, or release decisions in a GMP environment. - Have strong working knowledge of cGMP, relevant FDA cell-therapy and CMC guidance, ICH guidelines, 21 CFR Part 11, data integrity, and analytical validation. - Are comfortable operating broadly in a startup environment or lean organization and can work effectively without a separate specialist for every function. ### It’s a bonus if you: - Have direct experience with iPSC-derived cell therapies. - Have experience supporting cell-therapy programs through late-stage or pivotal clinical development. - Experience working across multiple therapeutic modalities, including direct small-molecule and/or gene-therapy Quality, QC, AD, or CMC experience.