Analytical Data Reviewer – LNP and Lipids
Core
Review and evaluate analytical data packages for lipid nanoparticle (LNP) formulations and lipid-based materials to ensure data integrity and regulatory compliance in a GMP environment.
Role type
Senior Analytical Data Reviewer (LNP/Lipids)
Builds
Data packages for stability studies, method development, and investigations supporting sample release and regulatory submissions.
Domain
Biopharmaceutical / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical chemistry knowledge, chromatographic data interpretation (HPLC, UPLC, LC-MS), GMP regulations, data integrity principles, Good Documentation Practices, attention to detail
Preferred skills
Lipid nanoparticle (LNP) technologies, lipid characterization, analytical method development, electronic laboratory systems (Veeva, SLIMS, JMP, LIMS)
Technologies
HPLC, UPLC, LC-MS, Veeva, SLIMS, JMP, LIMS
Responsibilities
Review analytical data packages for LNP formulations and lipid raw materials; Evaluate chromatographic data for accuracy and compliance; Verify calculations and instrument outputs; Review OOS and OOT investigations; Ensure records comply with GMP requirements; Maintain review timelines and tracking systems; Collaborate with cross-functional teams to resolve data discrepancies.
Seniority
Mid-Senior, hands-on IC
