Cell & Gene Therapy Data Scientist – CTD Expert, Hybrid

BioPharma Consulting JAD Group; Boston; Hybrid; USD 90,000 - 120,000; Full time

Job summary

BioPharma Consulting JAD Group in Boston, MA, seeks a biotechnology professional to verify, trend and interpret analytical data for CTD/eCTD Module 3 content that supports regulatory submissions. The role involves leading data verification, trending across manufacturing, stability and validation, and authoring CTD Module 3 sections.

You will collaborate with Analytical Development, QA, Regulatory, MSAT and external labs to ensure data integrity and robust justification for submission packages.

Qualifications

• Bachelor's degree or higher in Biology, Biochemistry, Analytical Chemistry or related field.
• 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.

Responsibilities

• 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.

Skills

Data analysis

Statistical analysis

Data mining

Data visualization

Technical writing

Education

Bachelor's degree or higher in Biology/Biochemistry/Analytical Chemistry

Tools

JMP

Spotfire

Power BI

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.

• 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.

• Contract: 6 months (November 16, 2026 – May 14, 2027), with possible extension
• Shift: Hybrid, standard business hours (40 hours/week)