Principal Scientist / Senior Scientist, Analytical Chemistry (Biopolymers)
BreezeBio Apply for this positionAbout this role
Principal Scientist / Senior Scientist, Analytical Chemistry (Biopolymers)
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. We operate in a fast-paced environment where creative problem-solving and high-impact data drive decisions.
The Role
We are seeking a Principal/Senior Scientist with deep expertise in polymer-based nanoparticle characterization to lead our analytical efforts from the bench. This is a hands-on role focused on developing the methods that define our platform. You will serve as the Subject Matter Expert (SME) for biopolymer characterization, driving method development, early-stage QC, and the analytical documentation required to successfully navigate IND-enabling studies.
The ideal candidate thrives at the interface of discovery and development, ensuring that our innovative chemistry is backed by robust, reproducible analytical methods.
Key Responsibilities
Method Development & Characterization
- Lead the development and optimization of analytical methods for polymer-based nanoparticles, with a heavy emphasis on GPC/SEC-MALS and HPLC.
- Characterize polymer molecular weight distributions, architecture, and purity to support formulation and process development.
- Translate early-stage "research" methods into robust, qualified procedures suitable for formal development.
QC, Documentation & Compliance
- Establish and execute QC protocols for incoming polymers and nanoparticle batches; perform routine testing to support internal programs.
- Author and review technical documents, including method qualification reports, SOPs, and batch records.
- Ensure all analytical activities meet phase-appropriate quality standards (moving toward cGMP/ICH alignment).
Regulatory & CMC Strategy
- Drive the analytical strategy for IND submissions, ensuring data integrity and method suitability for regulatory filings.
- Support CMC teams in defining specifications and control strategies for polymer-based delivery systems.
- Provide technical oversight for external CDMOs as methods are transferred for later-stage manufacturing.
Qualifications
Education & Experience
- Ph.D. in Chemistry, Polymer Science, or a related field with 5–8+ years of industry experience (MS/BS with equivalent proven experience will be considered).
- Direct experience in early-stage development and a clear understanding of the requirements to move a program through IND filing.
Technical Expertise (Required)
- Expert-level proficiency in GPC/SEC with MALS detection is essential.
- Strong hands-on experience with HPLC and various detector modalities (UV-Vis, RI, ELSD).
- Experience with nanoparticle characterization (DLS, NTA, Zeta potential) and biopolymer chemistry.
- Experience in authoring qualification reports and performing rigorous data review.
Leadership & Soft Skills
- Ability to work primarily onsite in a fast-paced laboratory environment.
- Strong "ownership" mindset—willing to do the bench work while thinking strategically about the long-term lifecycle of the product.
- Excellent communication skills for collaborating across chemistry and formulation teams.
Why Join BreezeBio?
- Opportunity to be a foundational member of a high-growth biotech.
- Work on cutting-edge gene therapy delivery technologies where your data directly influences the platform.
- Collaborative, science-driven culture with competitive compensation, equity, and benefits.
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.
About BreezeBio
Non-viral gene therapy delivery company (formerly GenEdit) using engineered polymer nanoparticles. Based in South San Francisco, CA.