Senior Scientist, Process Robustness & Investigations (CPV/APQR)

Integrated Resources, Inc.; Madison (NJ); Híbrido; USD 110.000 - 170.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Travel opportunities

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Data science tools (R, Python)

Statistical analysis

Data visualization

Educación

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

Herramientas

JMP

Minitab

Spotfire

Tableau

Power BI

Descripción del empleo

Work Location: 50% onsite at Giralda Farms

Hours: Mon - Fri 9:00 AM - 5:00 PM

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.

Travel: Up to 10% global travel required.