The posting
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:
About you:
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.
- 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 cell-based 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.
You might thrive in this role if you:
- Have 8+ years of relevant experience, with deep cell-therapy experience and substantial responsibility across QA/QMS, QC, Analytical Development, and/or CMC.
- Have taken cell-therapy programs through GMP manufacturing and clinical development.
- Have meaningful experience building and operating a phase-appropriate GMP Quality system.
- Have personally taken cell-therapy analytical methods through the full lifecycle, from development and characterization through qualification and validation, transfer, and routine GMP QC use, including 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.
We take pride in cultivating an environment that fosters collaboration, open communication, and authenticity. We believe that great results are best delivered by a highly creative team working in concert. We are an equal opportunity employer; we do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We are diverse in background and singular in mission.
