Global Product Development and Supply - Senior Scientist Engineer Investigator

Position Overview: 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 consultant will leverage Statistical Process Control (SPC), Multi-Variate Analysis (MVA), and data analytics tools to prepare data, evaluate process robustness, identify process drifts, support investigations, and drive continuous improvement initiatives.

Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a Global Product Development and Supply - Senior Scientist Engineer Investigator for our client in Madison, NJ.

ECLARO’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!

Position Overview:

• 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 consultant will leverage Statistical Process Control (SPC), Multi-Variate 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.

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 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.

Pay Rate: $62.12 - $65.89 / Hour

If hired, you will enjoy the following ECLARO Benefits:

• 401k Retirement Savings Plan administered by Merrill Lynch
• Commuter Check Pretax Commuter Benefits
• Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO

If interested, you may contact:
Paul Quibuyen

Christian.Quibuyen@eclaro.com

646-695-2942
Paul Quibuyen | LinkedIn

Equal Opportunity Employer: ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.