Senior Scientist, Data Science and Reporting (CPV/APQR)- Pharma (Hybrid- Madison, NJ) 

Senior Scientist, Data Science and Reporting (CPV/APQR) Pharma (Hybrid- Madison, NJ)

We are seeking a Senior Scientist, Data Science and Reporting (CPV/APQR) for a global pharmaceutical client. 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.

This is a 40-hour per-week, 6-month contract (extensions possible), 50% onsite role at client s office in Madison, NJ.

This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.

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.

Requirements

• 5+ years pharmaceutical experience in a GMP-regulated setting and 3+ years in a data management and analytics role
• Strong knowledge of data science tools such as JMP 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.
• Bachelor's Degree, MS or PhD in Life Sciences, Biotechnology, Chemical Engineering, Statistics, Pharmaceutical Sciences, Data Science, or a related discipline.

Please submit your resume to our network at https://www.stage4solutions.com/careers/ (please apply to the Senior Scientist, Data Science and Reporting (CPV/APQR) Pharma (Hybrid- Madison, NJ) role).

Please feel free to forward this project opening to others who may be interested.

Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.

Compensation: $58/hr. - $60.82/hr.