Principal/Senior Scientist, PK/PD Assays
Core
Lead the design, development, and qualification of pharmacokinetic (PK) and pharmacodynamic (PD) assays to characterize the biodistribution and biological activity of mRNA-LNP medicines in preclinical and IND-enabling studies.
Role type
Principal/Senior Scientist, PK/PD Assays
Builds
Bioanalytical assays for mRNA-LNP therapeutics
Domain
Biotechnology / Epigenetic reprogramming / mRNA-LNP therapeutics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
quantitative bioanalytical assay platforms (RT-qPCR, ddPCR, ELISA, MSD, Olink, SOMAscan, NGS), bioanalytical method qualification/validation (ICH M10), primary cell culture, tissue-derived sample workflows, biomarker discovery and validation
Preferred skills
bioanalytical method transfer, CRO management, preclinical drug development timelines, regulatory submissions (IND, TGA, CTD), nucleic acid–based PK assays, emerging therapeutic modalities (gene therapy, cell therapy)
Technologies
RT-qPCR, ddPCR, ELISA, MSD, Olink, SOMAscan, NGS
Responsibilities
Design and qualify PK/PD biomarker assays across platforms; discover and validate pharmacodynamic biomarkers; drive data analysis and reporting for bioanalytical studies; contribute to sample processing workflows including tissue harvesting and cell culture; mentor research associates and establish SOPs
Seniority
Senior, hands-on IC with mentorship responsibilities