QC Data Scientist, GMP Lab Analytics & LIMS Insights

BioSpace; City of Rensselaer (NY); On-site; USD 79,000 - 129,000; Full time

Job summary

Regeneron is building a digital Quality Control laboratory and seeks a QC scientist focused on data. You will validate instrument-to-LIMS data, maintain control limits, and turn QC data into actionable information for analysts and stakeholders.

The role involves statistical modeling, data visualization, and collaboration across QC, informatics, and IT/OT to ensure a healthy data pipeline and GMP compliance.

Qualifications

• BS/BA in Biochemistry, Chemistry, Biology with 6+ years of hands-on QC or analytical laboratory experience and data and statistics experience in a GMP pharmaceutical or biotechnology setting.
• A PhD with 2+ years of relevant experience is strongly preferred.
• Direct experience generating, reviewing, or troubleshooting analytical data from methods such as HPLC/UPLC (Empower), bioassays (cell-based potency, ELISA), or similar release and stability testing.
• Working knowledge of analytical and bioassay variability, including system suitability, assay controls, and distinguishing true signal from noise.
• Experience with GMP data integrity (ALCOA+), deviations, investigations, and CAPAs.
• Applied statistics: trending, control limits, and multivariate methods (PCA/PLS).
• Experience with at least one statistical or modeling tool (JMP, Minitab, SIMCA, Discoverant, MATLAB) and at least one visualization tool (Tableau, Spotfire, Power BI).

Responsibilities

• Execute daily validation and reconciliation of instrument-to-LIMS data flows across the lab bus, confirming the completeness, accuracy, and integrity of data transferred from instruments into LIMS and data lake solutions.
• Maintain and monitor statistically valid control limits and RBE logic. Triage flags and out-of-trend signals with method-specific scientific judgment and elevate issues.
• Validate parsing and data-transformation configurations for every new method onboarding, instrument qualification, and software release, ensuring analytical outputs are interpreted correctly before they reach LabWare.
• Troubleshoot data-transfer discrepancies at the scientific level, distinguishing formatting and rounding artifacts from true signal-integrity issues and drive them to resolution.
• Build and maintain dashboards, reports, and analytics that turn QC data into actionable information for analysts, managers, and stakeholders.
• Apply statistical and machine-learning-supported tools (multivariate analysis, trending, anomaly detection) to performance-monitoring programs and technical investigations.
• Support GMP data integrity (ALCOA+) for the scientific data layer, and contribute to investigations, CAPAs, and inspection readiness.
• Partner with QC analysts, laboratory informatics/IT, and OT to keep the scientific data pipeline healthy.
• Use LLMs (Claude, ChatGPT, etc.) to accelerate drafting, coding, and analysis, with the judgment to keep probabilistic AI out of validated GMP data and quality decisions.

Skills

SQL

Python

R

JMP

Minitab

SIMCA

Discoverant

MATLAB

Tableau

Spotfire

Power BI

Education

BS/BA in Biochemistry, Chemistry, Biology

PhD with 2+ years experience preferred

Tools

LabWare LIMS

Empower

LIMS

Job description

Regeneron is building a digital Quality Control laboratory and seeks a QC scientist focused on data. You will validate instrument-to-LIMS data, maintain control limits, and turn QC data into actionable information for analysts and stakeholders.

The role involves statistical modeling, data visualization, and collaboration across QC, informatics, and IT/OT to ensure a healthy data pipeline and GMP compliance.