Associate Director / Director, Analytical Development

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About this role

Associate Director / Director, Analytical Development South San Francisco, CA Associate Director / Director, Analytical Development Location: Brisbane, CA (Onsite) About BreezeBio BreezeBio is an early-stage biotech company building a next-generation delivery platform for genetic medicines. Our team integrates chemistry, payload design, formulation, and preclinical science to translate platform innovation into a pipeline of transformative therapies. As we scale our platform toward the clinic, we are seeking a strategic leader to architect our analytical function and build the infrastructure necessary for long-term success. The Role The Director of Analytical Development will be a foundational member of the CMC leadership team. You will be responsible for the strategic vision and operational execution of BreezeBio's analytical department. This role requires a "builder" mindset: you will decide what capabilities we build in-house (CAPEX), what we outsource to CDMOs, and how we manage our onsite, non-regulated QC to support rapid platform iteration. You will bridge the gap between early-stage polymer discovery and formal development, serving as the primary analytical architect for our IND-enabling programs and beyond. Key Responsibilities Strategic Infrastructure & CAPEX Build the Lab: Define the internal analytical roadmap; identify and justify CAPEX requirements for essential instrumentation (e.g., advanced GPC-MALS, HPLC/SEC, Particle Characterization) to support onsite development. Make vs. Buy Strategy: Determine which analytical methods are critical for internal "high-touch" development and which are best suited for transfer to external partners. Onsite QC Oversight: Manage the internal, non-regulated QC function to ensure rapid, high-quality data turnaround for the chemistry and formulation teams. CDMO

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