Head of Quality, Cell Therapy

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 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.

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.