Job Description
Job Title - Manager MS&T - Analytical Development
Job Summary
Responsible for leading analytical method transfer, verification, and lifecycle management for drug substance and drug product methods across R&D, QC, manufacturing, and external sites. The role provides MS&T support for scale-up, process validation, commercialization, and post-approval changes through scientific troubleshooting, comparability assessment, method robustness evaluation, and application of advanced analytical platforms in compliance with global regulatory guidelines.
Key Result Areas
- Ensure successful analytical method transfer across R&D, manufacturing, QC, and external CRO/CDMO sites.
- Deliver scientifically sound transfer packages, including protocols, gap assessments, risk evaluations, reports, and equivalence studies.
- Establish robust acceptance criteria, system suitability, and comparability requirem...
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