Senior Scientist Engineer Investigator

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.