Scientist, Drug Product Analytical
Core
Developing and implementing analytical methods to characterize Lipid Nanoparticles (LNPs) and RNA drug substances to support nucleic acid delivery technologies and drug product development.
Role type
Scientist, Drug Product Analytical
Builds
Analytical methods for RNA and LNP characterization
Domain
Biotechnology / mRNA-LNP delivery systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Ion-Pair Reversed-Phase Chromatography (IP-RP LC-UV/FLR), Lipid purity and content analysis via LC-CAD, Capillary Electrophoresis (CE) for RNA integrity, Dynamic Light Scattering/MALS/Cryo-TEM for particle size analysis, Method qualification and validation, Tech-transfer processes
Preferred skills
ICH Q2 (R1) and Q14 guidelines, Tech-transfer to CDMOs, Design of Experiments (DoE), Statistical analysis (JMP, Python, R)
Technologies
IP-RP LC-UV/FLR, LC-CAD, CE, DLS, MALS, Cryo-TEM, JMP, Python, R
Responsibilities
Design and execute analytical methods to assess identity, integrity, and purity of RNA and LNP products; Perform deep-dive analysis into mRNA integrity and lipid content for stability studies; Act as technical expert for CRO/CDMO partners on method development and validation; Interpret analytical assay data and prepare data packages; Author technical reports, SOPs, and validation protocols for regulatory filings
Seniority
Mid-level IC (1-3 years industry experience)