Analytical Trending Scientist
Core
Facilitate commercial stability studies, track batch enrollment, analyze and report stability data to ensure product quality and regulatory compliance.
Role type
Senior IC analytical scientist (stability)
Builds
Stability data reports, CTD dossiers, Annual Product Quality Reports
Domain
BioPharma / Pharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
stability data analysis, statistical software (JMP), LIMS, regulatory guidelines (ICH Q1A, Q5C), cGMP, batch identification, change control management, CTD authoring, risk-based judgment
Preferred skills
drug substance/product manufacturing knowledge, analytical/microbiological methods, project management, team leadership
Technologies
JMP, LIMS, SAP, TrackWise, Veeva, Microsoft Office
Responsibilities
Initiate and track commercial stability studies; author stability protocols and CTD sections; analyze and trend stability data; manage batch enrollment and annual requirements; support health authority inspections and CAPA activities; ensure compliance with stability procedures and regulations.
Seniority
Senior, hands-on IC
