BreezeBio Research Specialist/Scientist at BreezeBio to develop and execute quantitative bioanalytical and immune-monitoring assays supporting non-clinical PK, biodistribution, and PD studies. Focus on nucleic acid–based therapeutics.
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 assays. Work 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.
