Associate Scientist
Confirmed on the employer's own hiring board on Oct 14, 2026. First seen by Alion on Oct 1, 2026. QCS Staffing scores A on the Alion truth index.
Own and/or support analytical method transfers and validations in GMP Quality Control labs, both internally and externally - including generation of protocols, reports and acceptance criteria, co-ordination of execution, project management, and provision of program updates to leadership.Own and/or support analytical change controls for changes to global test methods or regulatory filings.Own and/or support relationships with external organizations for analytical testing supporting manufacture and release of commercial products.Provide oversight of external lab testing systems and documentation, and of associated Quality Agreements and change controls, to ensure compliance with requirements and regulatory filings.Lead and manage projects with a global mindset to direct and influence multiple remote teams.
What you’ll need:
Bachelor's degree in Biological Sciences, Chemistry or a related discipline.Extensive experience in Quality and Compliance organizations.Knowledge and experience of the commercial analytical method lifecycle.Demonstrated knowledge of analytical methods (in-process, release and stability for late-stage/commercial biologics), and of health authority regulations.Experience with analytical change controls in a GMP environment.
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