Senior Quality Control Data Scientist

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

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a QC scientist focused on data to join its digital Quality Control laboratory in Rensselaer, NY. You will validate instrument-to-LIMS data, maintain control limits behind RBE, and translate QC data into actionable insights for leadership.

The role requires hands-on QC or analytical lab experience in GMP settings, plus strong data and statistics skills. Expect on-site work with collaboration across IT/OT and QC teams.

Qualifications

• Hands-on QC or analytical lab experience in GMP/pharma setting.
• Experience generating, reviewing, or troubleshooting analytical data from methods such as HPLC/UPLC, bioassays, or related tests.
• Strong data and statistics skills to validate data integrity and drive decision making.

Responsibilities

• Validate instrument-to-LIMS data flows ensuring completeness, accuracy, and integrity of data.
• Maintain control limits and RBE logic; triage flags and investigate out-of-trend signals.
• Build dashboards and analytics turning QC data into actionable information for analysts and managers.

Skills

Hands-on QC

Data analysis

Statistics

SQL

Python

R

HPLC/UPLC

GMP data integrity

Education

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

PhD with 2+ years relevant experience (preferred)

Tools

Empower

LabWare LIMS

JMP

Minitab

MATLAB

Tableau

Power BI

Job description

Regeneron is building the digital Quality Control laboratory and needs a QC scientist who works in data. This role is for someone with hands‑on QC laboratory experience who also has strong data and statistics skills. You will validate that what reaches LIMS is exactly what left the instrument, maintain the statistical control limits behind Review by Exception (RBE), and turn QC data into information leaders can act on. Your judgment about analytical and bioassay variability is what makes this role work. You will work across the orchestration layer, LIMS, and instrument software, helping bring Industry 4.0 laboratories into practice. Day to day, you will deliver the QC scientific data framework 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 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. You lead 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 GMP data and quality decisions.

This Role Requires

• BS/BA in Biochemistry, Chemistry, Biology, or a related life science, 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).
• SQL and Python and/or R for data manipulation.
• Experience with at least one statistical or modeling tool (JMP, Minitab, SIMCA, Discoverant, MATLAB) and at least one visualization tool (Tableau, Spotfire, Power BI).

Preferred Experience

• LabWare LIMS experience
• Anomaly detection and machine‑learning exposure
• ETL, data cleansing, and data‑modeling experience

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 https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$78,700.00 - $128,700.00