Senior Scientist - Statistical Process Control (SPC) & Data Analytics

SOKOL GxP Services; Madison (NJ); Hybride; USD 110 000 - 160 000; Plein temps

Avantages offerts par ce poste

Health insurance with dental andVision

Holiday pay

401(k) program

Employee referral bonus program

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Statistical Process Control

Data Analytics

R programming

Python

Cross-functional collaboration

Communication

Formation

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

Outils

JMP

Python

Description du poste

We are seeking a Senior Scientist specializing in Statistical Process Control (SPC) and Data Analytics to support commercial cell therapy manufacturing within a Global Manufacturing Science & Technology (MSAT) organization.

This role focuses on preparing and analyzing manufacturing data, monitoring process performance, supporting Continued Process Verification (CPV) and Annual Product Quality Review (APQR) reporting, and configuring analytical systems to automate monitoring and reporting activities.

Key responsibilities:

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

Position details:

• Contract length: initial 6-month contract with potential extensions, up to 2 years in total, based on performance and client needs;
• Location: Madison, NJ 07940;
• Work arrangement: Hybrid, 50% onsite with flexible onsite days;
• Schedule: Monday–Friday, 9 AM–5 PM EST, 40 hours per week;
• Travel: Up to 10% globally;
• W-2 contract position;
• No C2C options;
• No visa sponsorship.

Required:

• Bachelor’s degree in Life Sciences, Biotechnology, Engineering, Statistics, Data Science, or a related discipline;
• 5+ years of pharmaceutical experience in a GMP-regulated environment;
• 3+ years of experience in data management and analytics;
• Strong hands-on experience with R for data preparation, manipulation, and analysis;
• Strong working knowledge of statistical analysis using JMP, R, or Python;
• Experience with statistical process control (SPC), process monitoring, and capability analysis;
• Applied coding experience supporting data analytics, reporting, or process monitoring;
• Ability to analyze manufacturing or quality datasets, identify trends, and communicate findings;
• Strong communication, technical writing, and cross-functional stakeholder management skills;
• Ability to work effectively within a matrix team.

Preferred:

• Experience supporting SPC for commercial cell therapy manufacturing;
• Experience with Continued Process Verification (CPV) and Annual Product Quality Review (APQR);
• Experience with multivariate analysis and process engineering;
• Experience configuring or automating statistical monitoring and reporting systems;
• Python automation experience;
• Experience leading meetings and managing small projects;
• Experience with Lean Six Sigma or Operational Excellence methodologies.
• Health insurance with dental and vision insurance options.
• Holiday pay.
• 401(k) program.
• Employee referral bonus program.
• The client retains the right to hire the contractor directly.