Manager, Analytical Data Science – CGT (Hybrid Boston)

Biopharma-Consulting-Jad-Group

Boston (MA)

Ibrido

USD 100.000 - 167.000

Tempo pieno

7 giorni fa

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Descrizione del lavoro

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

You will collaborate across QA, Regulatory, Manufacturing, and MSAT, author technical reports and support

Competenze

Bachelor's degree in biology/biochemistry/analytical chemistry or related field.
Minimum 5 years of pharmaceutical/biopharmaceutical industry experience.

Mansioni

Lead analytical data verification, trending and data mining across commercial manufacturing, stability, process validation and lifecycle programs.
Compile, review and analyze analytical datasets to identify trends, investigate anomalies and support scientific 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 preparation, review and lifecycle maintenance of CTD/eCTD Module 3 content (methods, specifications, validation summaries, stability, comparability and post-approval changes).