Senior Scientist - Statistical Process Control (SPC) & Data Analytics
SOKOL GxP Services · Madison
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.
Requirements
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.
Benefits
- 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.
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