Analytical Science and Technology Scientist

BioPharma Consulting JAD Group • Boston, MA

21h • Hybrid

About The Position

The Analytical Science and Technology (ASAT) Scientist supports analytical lifecycle management for commercial Cell and Gene Therapy (CGT) products at a biopharmaceutical company. The role focuses on analytical data verification, trending, mining, and interpretation to support commercial manufacturing, product lifecycle management, regulatory submissions, and health authority interactions. It is a manager-level position based in a hybrid work arrangement in Boston, Massachusetts, with standard business hours and a 40-hour workweek. The contract is approximately six months, from October 2026 to April 2027, with a possible extension.

Requirements

• B.S. or above in Biology, Biochemistry, Analytical Chemistry, or a related field.
• Minimum 5 years of pharmaceutical or biopharmaceutical industry experience.
• Strong understanding of analytical methods for biologics and/or cell and gene therapy products.
• Experience with data verification, data integrity review, trend analysis, and data mining.
• Experience supporting CTD/eCTD Module 3 documentation and regulatory submissions.
• Knowledge of JMP, Excel, Power BI, Spotfire, Minitab, or similar statistical tools.
• Familiarity with GMP, data integrity principles, ICH guidelines, and global regulatory expectations.
• Strong technical writing, organization, and communication skills.

Responsibilities

• Lead analytical data verification, trending, and data mining across commercial manufacturing, stability, process validation, and lifecycle programs.
• Compile, review, and analyze analytical datasets to identify trends, investigate anomalies, and support scientific conclusions.
• Generate statistical analyses, data visualizations, summaries, and technical assessments.
• Collaborate with Analytical Development, Quality, Manufacturing, Regulatory Affairs, MSAT, and external laboratories.
• Author and review technical reports, data summaries, scientific justifications, and regulatory support documents.
• Support preparation, review, and lifecycle maintenance of CTD/eCTD Module 3 content, including methods, specifications, validation summaries, stability, comparability, and post-approval changes.

What This Job Offers

• Career Level: Manager