Principal Specialist, Data Review – Analytical Method Development
Job Description
Key Responsibilities
- Independently review analytical method development data, protocols, reports, and supporting documentation to ensure accuracy, completeness, and scientific soundness.
- Evaluate chromatographic method development strategies, experimental design, and data interpretation for alignment with client expectations and regulatory requirements.
- Verify analytical data, including chromatographic outputs (e.g., HPLC, GC, IC, GCMS, LCMS), calculations, system suitability, and method performance characteristics.
- Ensure all work complies with GMP, data integrity principles (ALCOA+), internal SOPs, and applicable regulatory guidelines (e.g. ICH).
- Identify discrepancies, errors, or gaps in data and documentation, and drive resolution with appropriate stakeholders.
- Partner with Analytical Scientists and Project Group Leaders to ensure accurate interpretation and reporting of method development work.
- Provide client support as needed by offering technical insight and clarification related to data review findings.
- Serve as a technical resource for junior reviewers and scientific staff, providing guidance on data review practices and regulatory expectations.
- Contribute to the development and refinement of review procedures, best practices, and training materials.