Senior Quality Control Data Scientist

Regeneron; City of Rensselaer (NY); On-site; USD 120,000 - 180,000; Full time

Job summary

Regeneron is building a digital Quality Control laboratory and seeks a QC Data Scientist to ensure instrument-to-LIMS data integrity, monitor control limits, and turn QC data into actionable insights for analysts and managers.

You will validate data flows, build dashboards, apply multivariate analyses and ML tools, troubleshoot data-transfer issues, and support GxP data integrity across the scientific data layer in collaboration with QC, informatics, and IT.

Qualifications

• Must have strong analytics and data interpretation skills.
• Experience with QC data, LIMS data flows, and data validation.
• Experience with statistical control limits and trend analysis.

Responsibilities

• Validate instrument-to-LIMS data transfers for completeness and integrity.
• Maintain statistical control limits and Review by Exception logic.
• Build and maintain dashboards translating QC data into actionable insights.
• Apply multivariate analysis and anomaly detection to monitor performance.
• Troubleshoot data-transfer discrepancies and ensure data quality.
• Support GxP data integrity and assist investigations and CAPAs.

Skills

Statistics & data analysis

SQL & data modeling

Python or R

Tableau/Power BI/Spotfire

Machine learning basics

Education

BS/BA in Biochemistry, Chemistry, Biology, Data Science or related field

PhD preferred

Tools

Tableau

Spotfire

Power BI

JMP

Minitab

SIMCA

Discoverant

MATLAB

Job description

Build our future together:

Regeneron is building the digital Quality Control laboratory, and looking for a QC Data Scientist to keep that data layer running: validating that what reaches LIMS is what left the instrument, maintaining the statistical control limits behind Review by Exception, and turning QC data into information leaders can act on. Working across the orchestration, LIMS, and instrument software, helping to bring Industry 4.0 laboratories into practice, this role delivers the QC scientific data framework day to day, with strong scientific judgment.

When & where:

• Monday-Friday, 8:00am-4:30pm
• Location: Rensselaer, New York, United States

Discover your role:

• 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 (Empower and others) into LIMS and data lake solutions.
• Maintain and monitor statistically valid control limits and Review by Exception (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 the pipeline interprets analytical outputs correctly before they reach LabWare.
• Build and maintain dashboards, reports, and analytics that translate QC data into actionable information for analysts, managers, and stakeholders.
• Apply statistical and machine-learning-supported tools (multivariate analysis, trending, anomaly detection) to support performance-monitoring programs and technical investigations.
• Troubleshoot data-transfer discrepancies at the scientific level distinguishing formatting and rounding artifacts from true signal-integrity issues and driving them to resolution.
• Support GxP data integrity (ALCOA+) for the scientific data layer; contribute to investigations, CAPAs, and inspection readiness.
• Partner with QC analysts, laboratory informatics / IT, and OT to keep the scientific data pipeline healthy leading the scientific and data-quality dimension while infrastructure and platform administration remain with IT / OT.
• Use LLMs (Claude, ChatGPT, etc.) to accelerate drafting, coding, and analysis with the judgment to keep probabilistic AI out of validated GxP data and quality decisions.

This role requires:

• BS/BA Biochemistry, Chemistry, Biology, Data / Computational Science, or a related field; with 6+ years relevant analytical or QC data experience - preferably in the pharmaceutical or biotechnology industries. PhD strongly preferred with 2+ years relevant experience.
• Proven understanding of analytical and bioassay variability and the statistical basis for control limits, trending, and Review by Exception.
• Applied statistics and data analysis: multivariate methods (PCA / PLS), trending, and anomaly detection; exposure to machine-learning tools.
• Strong SQL and data-modeling skills (ETL, data cleansing, transformation) and programming for data manipulation (Python and/or R).
• Specialized statistical / modeling software (e.g., JMP, Minitab, SIMCA, Discoverant, MATLAB).
• Experience with Tableau, Spotfire, and Power BI.

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit ht