Job Summary

The Analytical Development Scientific Expert provides senior‑level scientific oversight and guidance for analytical development activities, with a regulatory‑authority level mindset and critical thinking approach. The role is responsible for reviewing, challenging, and strengthening investigational and analytical development reports to ensure they are scientifically robust, internally consistent, data‑driven, and defensible under potential regulatory scrutiny.

This role applies health‑authority‑style expectations when evaluating analytical strategies, data interpretation, conclusions, and justifications. The position ensures that analytical documentation is developed and finalized as if it were subject to regulatory authority assessment, enabling confident progression into submissions, inspections, and lifecycle management activities.

Key Responsibilities

• Perform expert review of investigational reports, analytical development reports, method development and validation reports, transfer reports, comparability assessments, and stability reports.
• Evaluate analytical data, interpretations, and conclusions with health‑authority level rigor and critical challenge.

Challenge assumptions, identify gaps, inconsistencies, and weak rationales, and drive scientifically sound improvements

Skill Requirements

Other Requirements