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Analytical Science and Technology Scientist - Cell and Gene Therapy

BioPharma Consulting JAD Group · Boston, Massachusetts, United States (Hybrid)

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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, with possible extension Shift: Hybrid, standard business hours (40 hours/week) Start: October 26, 2026