We are looking for a Senior Scientist specializing in Statistical Process Control (SPC) and Data Analytics to support a Global Manufacturing Science & Technology (MSAT) team within the pharmaceutical industry.
This role combines hands-on data preparation, applied statistical analysis, and coding to support manufacturing process monitoring, reporting, and continuous improvement. The ideal candidate is comfortable working with R or Python, preparing and validating datasets, applying statistical methods, and improving analytical workflows. Experience with AI-assisted coding tools is welcome.
Key Responsibilities:
- Prepare, clean, merge, validate, and analyze manufacturing and quality datasets using R or Python;
- Apply statistical process control (SPC), control charts, process capability analysis, and comparative statistical methods;
- Monitor process performance, identify trends, investigate statistical alerts, and communicate findings;
- Execute routine and ad hoc analyses and prepare reports and presentations for stakeholders;
- Improve analytical tools, data preparation workflows, and reporting processes through coding and automation;
- Support Continued Process Verification (CPV) and Annual Product Quality Review (APQR) activities;
- Contribute to analytical system configuration, technical documentation, and process improvements;
- Collaborate with MSAT, Manufacturing, Quality, and other cross-functional stakeholders.
Position details:
- Hourly rate: $55.80–$60.80;
- Contract length: Initial 6 months with possible extension, subject to client needs and budget approval;
- Location: Madison, NJ 07940 (Giralda Farms);
- Work arrangement: Hybrid, 50% onsite with flexible onsite days;
- Schedule: Monday–Friday, 9 AM–5 PM EST, with core hours of 10 AM–4 PM EST;
- Maximum hours: 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;
- Hands-on coding experience using R or Python for data preparation, manipulation, analysis, or reporting;
- Ability to assess data completeness, identify inconsistencies, and prepare reliable datasets for statistical analysis;
- Practical experience applying statistical methods, including statistical process control (SPC), process monitoring, capability analysis, or comparative statistics;
- Demonstrated project experience applying coding and statistical analysis to real business or technical problems;
- Strong analytical thinking, problem-solving, and technical communication skills;
- Ability to collaborate with cross-functional stakeholders and work effectively within a matrix team;
- Authorization to work in the United States without visa sponsorship.
Preferred:
- Experience in pharmaceutical manufacturing, process development, analytical development, or MSAT;
- Experience with Continued Process Verification (CPV) and Annual Product Quality Review (APQR);
- Experience supporting statistical process monitoring in commercial cell therapy or biopharmaceutical manufacturing;
- Experience with JMP, Minitab, or other statistical analysis software;
- Experience with control charts, Shewhart charts, Western Electric rules, t-tests, or Wilcoxon tests;
- Experience with coding automation or AI-assisted coding tools;
- Experience developing or improving analytical reporting systems;
- Knowledge of GMP requirements and pharmaceutical manufacturing processes;
- Experience with matrix leadership, project coordination, or stakeholder negotiation.
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.