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

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.