Analytical Science and Technology Scientist - Cell and Gene Therapy

BioPharma Consulting JAD Group • Boston, MA

1d • Hybrid

About The Position

Turn analytical data into decisions for commercial cell and gene therapy products at a leading biotechnology company in Boston, Massachusetts. The role verifies, trends, and interprets analytical data and authors CTD Module 3 content supporting regulatory submissions. It is a six-month contract with a possible extension, with a hybrid work arrangement and standard business hours totaling 40 hours per week. The stated start date is October 26, 2026.

Requirements

• Bachelor's degree or higher in Biology, Biochemistry, Analytical Chemistry, or a related field.
• At least 5 years of experience in pharma or biopharma.
• Experience with analytical methods for biologics or cell and gene therapy.
• CTD/eCTD Module 3 authoring or review experience.
• Knowledge of data integrity, trending, statistics, GMP, and ICH.
• Strong technical writing skills.

Responsibilities

• Lead analytical data verification, trending, and data mining across manufacturing, stability, and validation.
• Investigate anomalies and build statistical analyses and visualizations using JMP, Spotfire, and Power BI.
• Author technical reports, scientific justifications, and CTD/eCTD Module 3 sections.
• Partner with Analytical Development, QA, Regulatory, MSAT, and external laboratories.

What This Job Offers

• Career Level: Mid Level