Associate Director / Director, Analytical Development

BreezeBio • South San Francisco, CA

4d • Onsite

About The Position

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 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.

Requirements

• Ph.D. in Analytical Chemistry, Polymer Science, or a related field with 10+ years of industry experience.
• Minimum of 3–5 years in a formal leadership or department-management role within a biotech environment.
• Proven track record of moving programs from early-stage development through IND; experience with late-stage/commercialization is a significant plus.
• Polymer Expertise: Deep technical mastery of biopolymer characterization, specifically GPC/SEC-MALS, NMR, and HPLC.
• Operational Fluency: Demonstrated experience managing departmental budgets and executing CAPEX plans for analytical laboratories.
• Outsourcing Savvy: Extensive experience managing CDMOs and understanding the nuances of method transfer and external QC management.
• Regulatory Knowledge: Strong understanding of ICH guidelines and the CMC requirements for complex, multi-component drug delivery systems (LNPs/PNPs).
• The "Architect" Mindset: Ability to build a department from the ground up in a fast-paced, "builder" environment.
• Decisiveness: Proven ability to make high-stakes technical decisions with incomplete data sets.
• Communication: Exceptional ability to translate complex analytical data into strategic insights for the executive team.

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 & External Network Management
• Partner Selection: Lead the technical evaluation and selection of CDMOs and CTLs for clinical-grade method validation and GMP testing.
• Method Transfer: Oversee the successful transfer of biopolymer characterization methods from BreezeBio’s internal labs to external manufacturing sites.
• Executive Oversight: Act as the primary technical point of contact for external partners, ensuring they meet rigorous quality and timeline expectations.
• Regulatory & CMC Leadership
• IND Roadmap: Lead the authoring and review of CMC analytical sections for IND/IMPD filings, ensuring a robust control strategy for polymer-based delivery systems.
• Phase-Appropriate Strategy: Design and implement specification architectures that balance the flexibility of early-stage biotech with the requirements of regulatory agencies.
• SME Representation: Serve as the primary Subject Matter Expert (SME) for analytical chemistry during health authority interactions and internal program reviews.

Benefits

• Shape the Foundation: Direct influence over the technical and cultural build-out of a high-impact analytical department.
• High Visibility: Report directly into CMC leadership with significant exposure to the executive team.
• Competitive Rewards: Significant equity stake, competitive salary, and a comprehensive benefits package.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree