Senior Analytical Data Scientist — CGT (Contract, Hybrid)

BioPharma Consulting JAD Group

Boston (MA)

Hybrid

USD 120,000 - 160,000

Full time

7 days ago

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Job summary

BioPharma Consulting JAD Group seeks an Analytical Science and Technology (ASAT) Scientist at the Manager level to support analytical lifecycle management for commercial CGT products in Boston, MA. This role emphasizes data verification, trending, and data mining to support manufacturing, lifecycle management, regulatory submissions and health authority interactions.

The ideal candidate has a strong background in analytics for biologics or CGT, with at least 5 years in pharma, proficiency with

Qualifications

Minimum 5 years of pharmaceutical/biopharmaceutical industry experience.
BS or higher in Biology, Biochemistry, Analytical Chemistry or related field.

Responsibilities

Lead analytical data verification, trending and data mining across programs.
Compile, review and analyze analytical datasets to identify trends and support conclusions.
Generate statistical analyses, data visualizations, summaries and technical assessments.
Collaborate with Analytical Development, Quality, Manufacturing, Regulatory Affairs, MSAT and external laboratories.
Author and review technical reports, data summaries, scientific justifications and regulatory support documents.
Support CTD/eCTD Module 3 content maintenance (methods, specs, validation summaries, stability, changes).