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Analytical Science and Technology Scientist - Cell and Gene Therapy

BioPharma Consulting JAD Group · Boston, · Hybrid

  • Escritório em Boston
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Description

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