Senior Scientist – SPC & Data Analytics (Hybrid)

SOKOL GxP Services; Madison (NJ); Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Health insurance with dental andVision

Holiday pay

401(k) program

Employee referral bonus program

Job summary

SOKOL GxP Services in Madison, NJ seeks a Senior Scientist specializing in Statistical Process Control (SPC) and Data Analytics to support commercial cell therapy manufacturing within a Global MSAT organization.

The role focuses on preparing and analyzing manufacturing data, monitoring process performance, supporting CPV/APQR reporting, and configuring analytical systems to automate monitoring and reporting activities. Hybrid work with 50% onsite days.

Qualifications

• Bachelor’s degree in Life Sciences, Biotechnology, Engineering, Statistics, Data Science, or related discipline.
• 5+ years of pharmaceutical experience in a GMP-regulated environment.
• 3+ years of data management and analytics experience.
• Strong hands-on experience with R for data preparation, manipulation, and analysis.
• Experience with SPC, CPV and APQR is advantageous.
• Ability to analyze datasets, identify trends, and communicate findings clearly.

Responsibilities

• Prepare, clean, merge, and analyze manufacturing and quality datasets using R and statistical tools.
• Perform statistical process control, process capability, and multivariate analysis.
• Monitor CPV parameters, identify trends and drifts, and evaluate statistical alerts.
• Support CPV/APQR reporting, investigations, and root-cause analysis.
• Configure analytical systems and automate data preparation and reporting.
• Prepare technical reports and GMP documentation.
• Collaborate with Manufacturing, Quality, MSAT, Engineering, and other stakeholders.

Skills

Statistical Process Control

Data Analytics

R programming

Python

Cross-functional collaboration

Communication

Education

Bachelor’s degree in Life Sciences/ Biotechnology/ Engineering/ Statistics/ Data Science

Tools

JMP

Python

Job description

SOKOL GxP Services in Madison, NJ seeks a Senior Scientist specializing in Statistical Process Control (SPC) and Data Analytics to support commercial cell therapy manufacturing within a Global MSAT organization.

The role focuses on preparing and analyzing manufacturing data, monitoring process performance, supporting CPV/APQR reporting, and configuring analytical systems to automate monitoring and reporting activities. Hybrid work with 50% onsite days.