Associate Director / Director, Analytical Development

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 & 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.

Qualifications

Education & Experience

• 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.

Technical & Strategic Mastery

• 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).

Leadership Competencies

• 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.

Why Join BreezeBio?

• 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.

At BreezeBIo we are always looking to hire the absolute best talent and recognize that diversity in our experiences and backgrounds is what makes us stronger. We hire candidates of any race, color, ancestry, religion, sex, national origin, sexual orientation, gender identity, age, marital or family status, disability, veteran status, and any other status. These differences are what enable us to work towards the future we envision for ourselves, and the world.