Scientist I, PK/PD Bioanalytical Assays, Immunology

BreezeBio

$80K — $95K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Ph.D. or equivalent in a relevant life science field with 0-2 years of biotech/pharma experience.
  • Hands-on experience with quantitative bioanalytical assays, specifically RT-qPCR, ddPCR, ELISA, and MSD.
  • Experience with mRNA-LNP biodistribution or nucleic acid-based PK assays preferred.
  • Familiarity with emerging therapeutic modalities like gene therapy and nucleic acid therapeutics in varied settings.
  • Knowledge of pharmacodynamic and immune-monitoring assays integrated with PK sampling is essential.
  • Proficient in data analysis software (GraphPad Prism, FlowJo) and electronic lab notebook systems.
  • Strong communication skills for data presentation to cross-functional teams.

Responsibilities

  • Develop and execute quantitative bioanalytical assays for nucleic acid payload quantification.
  • Conduct pharmacodynamic and immune-monitoring assays in support of in vivo studies.
  • Contribute to design and execution of protocols for PK and biodistribution studies.
  • Support bioanalytical method development and ensure compliance with regulatory standards.
  • Analyze and summarize data for PK, biodistribution, and PD studies; present findings at meetings.
  • Collaborate with Discovery Biology and other teams to execute laboratory tasks effectively.
  • Maintain detailed lab documentation and organized records.

Benefits

  • Opportunity to work on cutting-edge therapeutics in a dynamic biotech environment.
  • Collaboration with skilled professionals across various scientific disciplines.
  • Access to advanced technologies and methodologies in bioanalytical sciences.
  • Encouragement of innovation and creative problem-solving in research.
  • Support for professional development and growth within the organization.
Full Job Description
We are seeking a talented and motivated Scientist 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/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. Responsibilities This is primarily a bench-based role (approximately 75% hands-on assay execution), spanning bioanalytical, pharmacodynamic, and biodistribution downstream assays, including: - Bioanalytical assay execution: 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. - Pharmacodynamic and immune-monitoring assays: Execute PD assays integrated with PK sample collection, including multicolor flow cytometry-based immune cell phenotyping, functional assays (e.g., IFN 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. - 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. - 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, ddPCR, 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 IFN 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.

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