Analytical Science and Technology Scientist - Cell and Gene Therapy

BioPharma Consulting JAD Group

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

Apply

Vacancy posted 20 days ago

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