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 requirements to ensure transfer readiness. Drive timely resolution of transfer-related issues through effective trou...

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