Senior Scientist Engineer Investigator

About this role

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.