Scientist I, PK/PD Bioanalytical Assays, Immunology

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 pharmacodynamic 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.

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 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.