CGT Analytics Specialist — Data, Trends & Submissions

Vertex Pharmaceuticals LLC; Boston (MA); In loco; USD 69.000 - 74.000; Tempo pieno

Descrizione del lavoro

Vertex Pharmaceuticals LLC in Boston seeks a Specialist, Analytical Science & Technology (ASAT) to support analytical lifecycle management for commercial CGT products within CMSC. The role focuses on data verification, trending, mining, and interpretation to support manufacturing, lifecycle management, and regulatory submissions.

Strong understanding of analytical methods for biologics/CGT is required, along with CTD/eCTD Module 3 experience, data integrity, and cross-functional collaboration.

Competenze

• Requires a B.S. or higher in Biology, Biochemistry, Analytical Chemistry, or related field.
• Minimum 5 years of pharmaceutical/biopharmaceutical industry experience.
• Experience supporting CTD/eCTD Module 3 documentation and regulatory submissions.

Mansioni

• Lead analytical data verification, trending, and data mining across programs (commercial manufacturing, stability, process validation).
• Compile, review, and analyze datasets to identify trends and support scientific conclusions.
• Generate statistical analyses and data visualizations for regulatory submissions and internal decision-making.
• Collaborate with cross-functional teams to collect, assess, and interpret data.
• Author and review technical reports and regulatory support documents.
• Support lifecycle maintenance of CTD/eCTD Module 3 content including methods, specs, validations.

Conoscenze

Data verification

Trend analysis

Data mining

Statistical analysis

Technical writing

GMP compliance

Data integrity

Project management

Formazione

Bachelor's degree in Biology/Biochemistry/Analytical Chemistry

Strumenti

JMP

Excel

Power BI

Spotfire

Minitab

Descrizione del lavoro

Vertex Pharmaceuticals LLC in Boston seeks a Specialist, Analytical Science & Technology (ASAT) to support analytical lifecycle management for commercial CGT products within CMSC. The role focuses on data verification, trending, mining, and interpretation to support manufacturing, lifecycle management, and regulatory submissions.

Strong understanding of analytical methods for biologics/CGT is required, along with CTD/eCTD Module 3 experience, data integrity, and cross-functional collaboration.