Sr. Scientist Engineer Investigator

The Senior Scientist is a key member of the Global Manufacturing Science & Technology (MSAT) Process Robustness and Investigations team, responsible for Continued Process Verification (CPV) and Annual Product Quality Review (APQR) activities across the cell therapy manufacturing network. The successful candidate will leverage statistical process control (SPC), multivariate analysis (MVA), and data analytics tools to prepare data, evaluate process robustness, identify process drifts, support investigations, and drive continuous improvement initiatives.

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Who We Are
Net2Source Inc. isn’t just another staffing company, we’re a powerhouse of innovation, connecting top talent with the right opportunities. Recognized for 300% growth in the past three years, we operate in 34 countries with a global team of 5,500+. Our mission? To bridge the talent gap with precision—Right Talent. Right Time. Right Place. Right Price.

Job Title: Senior Scientist, Process Robustness & Investigations (CPV/APQR)
Work Location: 50% onsite at Giralda Farms, Madison, NJ 07940
Duration: 06+ Months (Extendable)
Hours: Mon-Fri 9am-5pm
 
Pay Rate: $55.00 - 60.82/hr on W2
 

Name Required Experience data science Yes 3-5 yrs   JMP statistical software Yes 3-5 yrs   R language Yes 3-5 yrs   Automation w/Python No     Compliance & Regulatory reporting No

 
 
 
Must Have List:

• Strong working knowledge of data preparation tools in R.
• Strong working knowledge of general statistical analysis tools in JMP, R, or Python and specifically tools for process monitoring and capability analyses.
• Ability to successfully engage and support stakeholders as part of a matrix team.
• 5+ years pharmaceutical experience in a GMP-regulated setting
• 3+ years in a data management and analytics role

 
Summary:
The Senior Scientist is a key member of the Global Manufacturing Science & Technology (MSAT) Process Robustness and Investigations team, responsible for Continued Process Verification (CPV) and Annual Product Quality Review (APQR) activities across the cell therapy manufacturing network. This role supports commercial manufacturing by monitoring process and product performance, analyzing manufacturing and quality data, identifying trends, assessing process control, and ensuring timely reporting to meet regulatory and business requirements.
The successful candidate will leverage statistical process control (SPC), multivariate analysis (MVA), and data analytics tools to prepare data, evaluate process robustness, identify process drifts, support investigations, and drive continuous improvement initiatives. This position collaborates closely with cross-functional stakeholders, including Manufacturing, Quality Assurance, Quality Control, Supply Chain, Project Management, and site and global MSAT teams.
 
Key Responsibilities
• Monitor and trend CPV parameters to ensure processes remain in a state of control.
• Support preparation of CPV and APQR reports in accordance with established timelines and regulatory expectations.
• Perform statistical analysis, SPC monitoring, and multivariate modeling to improve process understanding and product robustness.
• Evaluate statistical alert events, identify trends or gaps, and communicate findings to stakeholders.
• Support investigations, root cause analyses, and data-driven decision making.
• Author, review, and approve technical reports, procedures, and other GMP documentation.
• Identify operational excellence opportunities and recommend continuous process improvements.
• Partner with global and site functions to support process monitoring, manufacturing performance, and quality objectives.
 
Qualifications
• Bachelor's Degree, MS or PhD in Life Sciences, Biotechnology, Chemical Engineering, Statistics, Pharmaceutical Sciences, Data Science, or a related discipline.
• Strong knowledge of data science tools such as or R and Python.
• Experience in biopharmaceutical, pharmaceutical, cell therapy, or advanced therapy manufacturing environments, including CPV, APQR, process validation lifecycle concepts, and GMP regulations.
• Experience with statistical analysis, SPC, process capability analysis, and data visualization tools such as JMP, Minitab, Spotfire, Tableau, Power BI.
• Demonstrated ability to analyze large datasets, support investigations, and communicate technical findings effectively.
• Strong technical writing, project management, and cross-functional collaboration skills.
• Experience in cell therapy manufacturing and Lean Six Sigma methodologies is preferred.
 
Why Work With Us?
We believe in more than just jobs—we build careers. At Net2Source, we champion leadership at all levels, celebrate diverse perspectives, and empower you to make an impact. Think work-life balance, professional growth, and a collaborative culture where your ideas matter.
Our Commitment to Inclusion & Equity
Net2Source is an equal opportunity employer, dedicated to fostering a workplace where diverse talents and perspectives are valued. We make all employment decisions based on merit, ensuring a culture of respect, fairness, and opportunity for all, regardless of age, gender, ethnicity, disability, or other protected characteristics.
Awards & Recognition
• America’s Most Honored Businesses (Top 10%)
• Fastest-Growing Staffing Firm by Staffing Industry Analysts
• INC 5000 List for Eight Consecutive Years
• Top 100 by Dallas Business Journal
• Spirit of Alliance Award by Agile1
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