Technical skills
Business intelligenceQuality AssuranceTechnical writing
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.
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