Research Specialist/Scientist, PK Bioanalytical Assays

BreezeBio is a rapidly-growing, early-stage company developing a proprietary and novel delivery platform with the potential to transform genetic medicine. Our interdisciplinary team works together across chemistry, payload design, formulation, and screening and preclinical groups to advance our NanoGalaxy® hydrophilic nanoparticle (HNP) platform toward a pipeline of therapeutic candidates. BreezeBio fosters an exciting and dynamic environment where we value impactful data and creative solutions. We are seeking talented and motivated individuals to join our team as we expand across all functions within the organization. Join us in Brisbane, CA, to be at the forefront of the future of genetic medicine. We are seeking a talented and motivated Researcher to join our Immunology team supporting non-clinical pharmacokinetic (PK), biodistribution, and pharmacodynamic (PD) evaluation of BreezeBio's NanoGalaxy® hydrophilic nanoparticle (HNP) platform for nucleic acid–based therapeutics. This individual will report to the Principal Scientist leading PK Bioanalytical Assays within the Immunology team and will be an individual contributor responsible for developing, executing, and interpreting quantitative bioanalytical and immune-monitoring assays that support IND-enabling non-clinical studies. The ideal candidate will have hands-on experience with quantitative bioanalytical platforms in complex biological matrices, nucleic acid–based PK/biodistribution assays, and pharmacodynamic immune assays, gained in the context of emerging therapeutic modalities such as gene therapy and nucleic acid therapeutics. Individuals with a successful track record of independent bench execution, rigorous data analysis, and teamwork in a fast-paced biotech environment are preferred. Job title and level will be commensurate with the candidate’s depth of scientific expertise and relevant experience. **Responsibilities** This is primarily a bench-based role (approximately 75% hands-on assay execution), spanning bioanalytical, pharmacokinetics, pharmacodynamic, and biodistribution downstream assays, including: - **Bioanalytical assay execution:** Develop, optimize, and independently execute quantitative bioanalytical assays — RT-qPCR, ELISA, and MSD — to quantify nucleic acid payload and protein analytes in complex biological matrices (serum, plasma, tissue homogenates) supporting PK, biodistribution, and toxicokinetic evaluations of mRNA-HNP and other nucleic acid–based therapeutics. - **Study design and execution:** Contribute to design, protocol development, and execution of in vivo downstream assays for PK, biodistribution, PD, and toxicology studies (Bioanalytical and PD assays) in rodent and other preclinical models supporting IND-enabling programs. - **Pharmacodynamic assays support:** Support executing PD assays integrated with PK sample collection, including multicolor flow cytometry–based immune cell phenotyping, functional assays (e.g., IFNγ ELISpot/FluoroSpot, Treg suppression assays), and cytokine multiplex profiling (MSD, CBA) to characterize antigen-specific immune activation, tolerance, and target engagement across in vivo studies. - **Method development and rigor:** Support bioanalytical method development, qualification, and troubleshooting in alignment with regulatory bioanalytical expectations; maintain assay robustness, reproducibility, and appropriate documentation for regulatory submissions. - **Data analysis and reporting:** Independently analyze, interpret, and summarize PK, biodistribution, and PD data (e.g., non-compartmental PK parameters, tissue distribution profiles, immune modulation endpoints); present results at team, cross-functional, and external meetings. - **Collaboration and communication:** Significant interaction with Discovery Biology team in developing PD and Immune monitoring cooperatively with peers across Invivo, and Formulation, in a highly matrixed lab environment; keep detailed and organized lab records/ELN entries. **Education and Qualifications** - Ph.D. or equivalent in Pharmacology, Toxicology, Immunology, Molecular Biology, or a related life science field, with 0–2 years of relevant biotech/pharma industry or postdoctoral experience. - Hands-on experience with quantitative bioanalytical assay platforms — RT-qPCR, ELISA, and MSD — in complex biological matrices (serum, plasma, tissue homogenates) is required. - Experience with mRNA-LNP biodistribution assays or other nucleic acid–based PK assays (e.g., quantification of mRNA/LNP payload in tissues, ASO/siRNA PK) strongly preferred. - Experience working with emerging therapeutic modalities — gene therapy, nucleic acid therapeutics (mRNA, ASO, siRNA) — in an academic, CRO, or industry setting. - Hands-on experience with pharmacodynamic and immune-monitoring assays integrated with PK sampling, including: - Immune cell phenotyping by multicolor (8+ color) flow cytometry. - Functional assays such as IFNγ ELISpot/FluoroSpot and Treg suppression assays. - Cytokine multiplex profiling (MSD, CBA) and related immune-based readouts. - Familiarity with bioanalytical method development/qualification principles (e.g., consistent with FDA/ICH bioanalytical method validation guidance) preferred. - Proficiency with relevant data analysis software (e.g., GraphPad Prism, FlowJo, Phoenix WinNonlin) and electronic lab notebook/LIMS systems. - Strong written and verbal communication skills, with the ability to present data clearly to cross-functional teams. - Work authorization in the US is required. **Abilities and Attributes** - A highly professional, enthusiastic, self-starting, and goal-focused scientist. - Intellectually agile, curious, and able to thrive in a fast-paced, dynamic environment. - Excels at technical innovation and creative problem solving, prevention, and solution. - Open-minded, cooperative, and capable of adapting quickly to shifting program priorities. - Experience working collaboratively across functional groups and with external partners (CROs, academic collaborators). - Personable, sociable, and eager to help build BreezeBio's culture and future. 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.