# Analytical Science and Technology Scientist

**Company:** [BioPharma Consulting JAD Group](https://jobs.workable.com/companies/pScfjBzGATtPx3geL93jwD.md)
**Location:** Boston, United States
**Workplace:** hybrid
**Employment type:** Contract

[Apply for this job](https://jobs.workable.com/view/77880708-e94f-40e5-b6b2-880f69acb928)

## Description

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).

## Requirements

**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

## Benefits

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