Scientist, CMC Quantitative Sciences
Core
Scientist applying statistics, data science, machine learning, and mechanistic modeling to solve scientific and operational problems across product, process, and platform lifecycles in CMC.
Role type
Senior IC quantitative scientist (CMC)
Builds
Reproducible analyses, models, code, visualizations, dashboards, and pipelines for CMC decision-making
Domain
Biopharmaceutical manufacturing and development
Deliverable
production ML models | dashboards & analysis | research
Required skills
applied statistics, machine learning, predictive modeling, mechanistic modeling, data engineering, R, Python, SQL, JMP, Statistica, Minitab, regulatory guidance (ICH/FDA/EMA/WHO), GxP principles
Preferred skills
multivariate modeling, manufacturing data systems (MES/LIMS/SAP), automated reporting, cloud data platforms, risk-based decision-making
Technologies
R, Python, SQL, JMP, Statistica, Minitab, MES, LIMS, SAP, DeltaV, Chromeleon
Responsibilities
Independently plan and execute quantitative analyses and models; translate scientific questions into analytical objectives; lead defined workstreams and manage timelines; partner with cross-functional teams to design studies and translate results; develop reproducible code and documentation aligned with GxP; evaluate data quality and improve data practices; communicate complex technical findings to diverse audiences; mentor colleagues and contribute to knowledge sharing.
Seniority
Senior, hands-on IC with leadership of workstreams