Research Specialist/Scientist, PK Bioanalytical Assays
Core
Develop, execute, and interpret quantitative bioanalytical and immune-monitoring assays to support non-clinical PK, biodistribution, and PD evaluations of nucleic acid-based therapeutics.
Role type
Research Specialist/Scientist (PK Bioanalytical Assays)
Builds
IND-enabling non-clinical studies for NanoGalaxy® hydrophilic nanoparticle (HNP) platform
Domain
Biotechnology / Gene Therapy / Nucleic Acid Therapeutics
Required skills
RT-qPCR, ELISA, MSD, multicolor flow cytometry, IFNγ ELISpot/FluoroSpot, Treg suppression assays, cytokine multiplex profiling, non-compartmental PK analysis, bioanalytical method development/qualification
Preferred skills
mRNA-LNP biodistribution assays, gene therapy experience, FDA/ICH bioanalytical guidance familiarity, GraphPad Prism, FlowJo, Phoenix WinNonlin
Responsibilities
Develop and optimize quantitative bioanalytical assays for nucleic acid payload and protein analytes; execute in vivo downstream assays for PK, biodistribution, and toxicology; support PD assays including immune cell phenotyping and functional assays; maintain assay robustness and regulatory documentation; analyze and summarize PK, biodistribution, and PD data; collaborate with Discovery Biology, Invivo, and Formulation teams.
Seniority
Junior to Mid-level, hands-on IC