Turn analytical data into decisions for commercial cell and gene therapy products at a leading biotechnology company in Boston, Massachusetts. You will verify, trend and interpret analytical data, then author the CTD Module 3 content that supports regulatory submissions.

What you'll do

• Lead analytical data verification, trending and data mining across manufacturing, stability and validation.
• Investigate anomalies; build statistical analyses and visualizations (JMP, Spotfire, Power BI).
• Author technical reports, scientific justifications and CTD/eCTD Module 3 sections.
• Partner with Analytical Development, QA, Regulatory, MSAT and external labs.

Requirements

• Bachelor's degree or higher in Biology, Biochemistry, Analytical Chemistry or related.
• 5+ years in pharma/biopharma; analytical methods for biologics or cell and gene therapy.
• CTD/eCTD Module 3 authoring or review (required).
• Data integrity, trending and statistics; GMP and ICH; strong technical writing.

Benefits

• Contract: 6 months (November 16, 2026 – May 14, 2027), with possible extension
• Shift: Hybrid, standard business hours (40 hours/week)