Senior Scientist: Process Robustness & CPV Investigations

Integrated Resources, Inc.; Madison (NJ); Hybrid; USD 110,000 - 170,000; Full time

Benefits offered by this job

Travel opportunities

Job summary

Integrated Resources, Inc (IRI) is seeking a Senior Scientist for the Global MSAT team in New Jersey. The role focuses on CPV and APQR activities across the cell therapy manufacturing network, monitoring process and product performance, and ensuring timely regulatory reporting.

You will apply SPC, multivariate analysis, and data analytics to evaluate process robustness and drive continuous improvement, partnering with Manufacturing, QA, QC, Supply Chain, PMO, and site/global MSAT teams.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• MS or PhD in Life Sciences or related discipline preferred.
• Experience with CPV, APQR, process validation lifecycle concepts and GMP regulations.

Responsibilities

• Monitor CPV parameters and trends to keep processes in control.
• Prepare CPV and APQR reports within timelines and regulatory expectations.
• Perform statistical analysis, SPC, and multivariate modeling to improve process understanding.
• Evaluate statistical alert events, identify trends or gaps, communicate findings to stakeholders.
• Support investigations, root cause analyses, and data-driven decisions.
• Author, review, and approve GMP documentation and technical reports.
• Identify operations excellence opportunities and drive continuous improvements.
• Collaborate with global and site teams to monitor manufacturing performance and quality objectives.

Skills

Data science tools (R, Python)

Statistical analysis

Data visualization

Education

Bachelor's degree in Life Sciences or related field

MS or PhD in Life Sciences, Biotechnology, Chemical Engineering, Statistics, Pharmaceutical Sciences, Data Science or related discipline

Tools

JMP

Minitab

Spotfire

Tableau

Power BI

Job description

Integrated Resources, Inc (IRI) is seeking a Senior Scientist for the Global MSAT team in New Jersey. The role focuses on CPV and APQR activities across the cell therapy manufacturing network, monitoring process and product performance, and ensuring timely regulatory reporting.

You will apply SPC, multivariate analysis, and data analytics to evaluate process robustness and drive continuous improvement, partnering with Manufacturing, QA, QC, Supply Chain, PMO, and site/global MSAT teams.