Analytical Science and Technology Scientist

We are seeking an Analytical Science and Technology (ASAT) Scientist at the Manager level to support analytical lifecycle management for commercial Cell and Gene Therapy (CGT) products at a biopharmaceutical company in Boston, Massachusetts. This role focuses on analytical data verification, trending, mining and interpretation to support commercial manufacturing, product lifecycle management, regulatory submissions and health authority interactions.

Key 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 (methods, specifications, validation summaries, stability, comparability and post-approval changes).

Requirements

Education and Experience

• B.S. or above in Biology, Biochemistry, Analytical Chemistry or related field
• Minimum 5 years of pharmaceutical/biopharmaceutical industry experience

Required Knowledge and Skills

• 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
• 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

Benefits

• Contract position: approximately 6 months (October 2026 – April 2027), with possible extension
• Shift: Standard business hours, 40 hours/week
• Hybrid – Boston, Massachusetts