Head of Quality and Analytical Development, Cell Therapy

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 our iPSC-derived cell therapy programs. You will continue building the Quality Unit supporting our internal cGMP manufacturing bring practical regulatory and industry perspective to the team and guide Analytical Development and QC work. You will also help provide Quality and analytical oversight across our broader pipeline including small-molecule and gene-therapy programs.

You will report to the CEO.

Youre a first-principles thinker who believes in building the simplest most effective team and systems for each phase of development. Youve 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. Youre comfortable moving between technical details Quality decisions and broader program strategy while staying directly involved with the work.

Youre optimistic about our ability to positively impact the human condition and extend healthy human lifespan.

• Lead Retros 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 Retros 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 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.

• 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.