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