Analytical Science and Technology Scientist

Biopharma-Consulting-Jad-Group; Boston (MA); Ibrido; USD 100.000 - 167.000; Tempo pieno

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).

Conoscenze

Data verification

Data integrity

Trend analysis

Data mining

CTD/eCTD support

Regulatory submissions

JMP

Excel

Power BI

Spotfire

Minitab

GMP knowledge

Technical writing

Formazione

B.S. in Biology/Analytical Chemistry/Related

Strumenti

JMP

Excel

Power BI

Spotfire

Minitab

Descrizione del lavoro

We are seeking an Analytical Science and Technology (ASAT) Scientist at the Manager level to support analytical lifecycle management for commercial Cell and Gene Therapy (CGT) products at a biopharmaceutical company in Boston, Massachusetts. This role focuses on analytical data verification, trending, mining and interpretation to support commercial manufacturing, product lifecycle management, regulatory submissions and health authority interactions.

Key Responsibilities

• 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).

Education and Experience

• B.S. or above in Biology, Biochemistry, Analytical Chemistry or related field
• Minimum 5 years of pharmaceutical/biopharmaceutical industry experience

Required Knowledge and Skills

• Strong understanding of analytical methods for biologics and/or cell and gene therapy products
• Experience with data verification, data integrity review, trend analysis and data mining
• Experience supporting CTD/eCTD Module 3 documentation and regulatory submissions
• JMP, Excel, Power BI, Spotfire, Minitab or similar statistical tools
• Familiarity with GMP, data integrity principles, ICH guidelines and global regulatory expectations
• Strong technical writing, organization and communication skills

• Contract position: approximately 6 months (October 2026 – April 2027), with possible extension
• Shift: Standard business hours, 40 hours/week
• Hybrid – Boston, Massachusetts