Senior QC Data Scientist (GMP Analytics & LIMS)

Regeneron Pharmaceuticals, Inc.; City of Rensselaer (NY); On-site; USD 79,000 - 129,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Rensselaer, NY seeks a QC scientist who blends hands‑on laboratory work with data and statistics to ensure data integrity from instrument to LIMS.

You will validate methods, maintain control limits, build dashboards, and apply multivariate analysis and ML‑assisted tools to turn QC data into actionable insights for analysts and management. Collaborating with QC, informatics, IT/OT teams, and leveraging LabWare LIMS and visualization tools, you will help advance

Qualifications

• BS/BA in Biochemistry, Chemistry, Biology or related life science with 6+ years hands-on QC experience.
• PhD with 2+ years relevant experience preferred.
• Experience with HPLC/UPLC (Empower) and bioassays.
• Proficiency in GMP data integrity (ALCOA+), deviations, investigations, and CAPAs.
• SQL and Python or R; familiarity with JMP, Minitab, SIMCA, Discoverant, MATLAB; visualization tools.

Responsibilities

• Validate instrument-to-LIMS data flows ensuring data integrity.
• Maintain control limits and RBE logic; triage flags and out-of-trend signals.
• Validate parsing/configurations for new method onboarding and software releases.
• Troubleshoot data-transfer discrepancies and distinguish artifacts from true signals.
• Build dashboards and analytics turning QC data into actionable information for analysts and managers.
• Apply statistical and machine-learning tools to monitoring programs and investigations.
• Support GMP data integrity and contribute to CAPAs and inspections.
• Collaborate with QC analysts, informatics/IT, and OT to keep the scientific data pipeline healthy.

Skills

Hands-on QC laboratory experience

Data analysis

Statistical knowledge

SQL and Python and/or R

Education

BS/BA in Biochemistry, Chemistry, Biology or related life science

PhD with 2+ years relevant experience preferred

Tools

LabWare LIMS

JMP

Minitab

SIMCA

Discoverant

MATLAB

Tableau/Power BI/Spotfire

Job description

Regeneron Pharmaceuticals, Inc. in Rensselaer, NY seeks a QC scientist who blends hands‑on laboratory work with data and statistics to ensure data integrity from instrument to LIMS.

You will validate methods, maintain control limits, build dashboards, and apply multivariate analysis and ML‑assisted tools to turn QC data into actionable insights for analysts and management. Collaborating with QC, informatics, IT/OT teams, and leveraging LabWare LIMS and visualization tools, you will help advance