Senior Scientist - Statistical Process Control (SPC) & Data Analytics
About The Position
The Senior Scientist specializing in Statistical Process Control (SPC) and Data Analytics supports a Global Manufacturing Science & Technology (MSAT) team in the pharmaceutical industry. The role combines hands-on data preparation, applied statistical analysis, and coding to support manufacturing process monitoring, reporting, and continuous improvement. The position is hybrid, based in Madison, New Jersey, with 50% onsite work and flexible onsite days. The schedule is Monday–Friday, 9 AM–5 PM EST, with core hours of 10 AM–4 PM EST; the maximum is 40 hours per week. Global travel of up to 10% may be required. This is a W-2 contract initially for six months, with a possible extension subject to client needs and budget approval. The hourly rate is $55.80–$60.80. No C2C arrangements or visa sponsorship are available. The client may hire the contractor directly.
Requirements
- Bachelor's degree in Life Sciences, Biotechnology, Engineering, Statistics, Data Science, or a related discipline.
- At least 5 years of pharmaceutical experience in a GMP-regulated environment.
- At least 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 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.
Nice To Haves
- 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.
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.
- Perform 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.
Benefits
- Health insurance with dental and vision insurance options.
- Holiday pay.
- 401(k) program.
- Employee referral bonus program.
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What This Job Offers
Career Level
Senior
