Cell & Gene Therapy Analytics Scientist (CTD Module 3)

Biopharma-Consulting-Jad-Group; Boston (MA); Hybrid; USD 83,000 - 152,000; Full time

Job summary

Biopharma-Consulting-Jad-Group in Boston, MA is seeking a specialist to turn analytical data into regulatory-ready CTD Module 3 content. The role involves verifying, trend analysis and data mining across manufacturing, stability and validation to support submissions.

You will author CTD/eCTD Module 3 sections, prepare technical reports and coordinate with Analytical Development, QA, Regulatory, MSAT and external labs. Hybrid work with standard business hours, contract for 6 months.

Qualifications

• Bachelor's degree or higher in biology, biochemistry, analytical chemistry, or related field.
• 5+ years in pharma/biopharma with analytical methods for biologics or cell/gene therapy.
• CTD/eCTD Module 3 authoring or review experience required.
• Data integrity, trending and statistics; GMP and ICH familiarity; 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 CTD/eCTD Module 3 sections and technical reports.
• Partner with Analytical Development, QA, Regulatory, MSAT and external labs.

Job description

Biopharma-Consulting-Jad-Group in Boston, MA is seeking a specialist to turn analytical data into regulatory-ready CTD Module 3 content. The role involves verifying, trend analysis and data mining across manufacturing, stability and validation to support submissions.

You will author CTD/eCTD Module 3 sections, prepare technical reports and coordinate with Analytical Development, QA, Regulatory, MSAT and external labs. Hybrid work with standard business hours, contract for 6 months.