QC Data Reviewer - LNP and Lipids
Core
Reviewing and evaluating analytical quality data for LNP formulations and lipid materials across stability studies, method development, and investigations to ensure data integrity and regulatory compliance.
Role type
QC Data Reviewer (LNP and Lipids)
Builds
Analytical data packages and OOS/OOT investigation reports for LNP and lipid-based products
Domain
Biopharmaceuticals / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP regulations, Good Documentation Practices, chromatographic data interpretation (HPLC, UPLC, LC-MS), data verification, regulatory compliance
Preferred skills
LNP and lipid technologies familiarity, method development experience, software systems (SLIM, Veeva, JMP, LIMS)
Responsibilities
Review analytical data packages from stability studies, method development, and investigations; Evaluate OOS/OOT investigation reports for completeness and scientific soundness; Verify calculations, data transcriptions, and chromatographic data; Ensure documentation adheres to GMP and regulatory guidelines; Maintain review timelines and tracking logs; Partner with analytical and quality teams to resolve data discrepancies
Seniority
Mid-level, hands-on IC
