Scientist I, PK/PD Bioanalytical Assays, Immunology

BreezeBio • Brisbane, CA

3d • Onsite

About The Position

BreezeBio is seeking a talented and motivated Scientist to join their Immunology team. This role will support non-clinical pharmacokinetic (PK), biodistribution, and pharmacodynamic (PD) evaluation of BreezeBio's NanoGalaxy® hydrophilic nanoparticle (HNP) platform for nucleic acid–based therapeutics. The individual will report to the Principal Scientist leading PK/PD 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.

Requirements

• 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, ddPCR, ELISA, and MSD — in complex biological matrices (serum, plasma, tissue homogenates) is required.
• 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.
• 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.
• 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.

Nice To Haves

• 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.
• Familiarity with bioanalytical method development/qualification principles (e.g., consistent with FDA/ICH bioanalytical method validation guidance) preferred.

Responsibilities

• Develop, optimize, and independently execute quantitative bioanalytical assays — RT-qPCR, ddPCR, 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.
• Execute 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.
• 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.
• Support bioanalytical method development, qualification, and troubleshooting in alignment with regulatory bioanalytical expectations; maintain assay robustness, reproducibility, and appropriate documentation for regulatory submissions.
• 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.
• Significant interaction with Discovery Biology team in developing PD and Immune monitoring assays.
• Work cooperatively with peers across Invivo, and Formulation, in a highly matrixed lab environment; keep detailed and organized lab records/ELN entries.

What This Job Offers

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