Walk-in Interviews - Analytical R&D @ Tuni

MSN Group

4 - 7 years

3 - 6 Lacs

hyderabad

Posted:23 hours ago| Platform:

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Skills Required

analytical method validation analytical method validation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Develop, optimize, and validate analytical methods (HPLC, UPLC, GC, LC-MS, dissolution, etc.) for oncology drug substances and drug products.
Perform characterization, stability testing, and release testing of clinical and commercial oncology formulations.
Prepare analytical documentation including method validation protocols, reports, SOPs, and regulatory submission documents as per ICH and FDA/EMA guidelines.
Support formulation development teams by providing analytical insights for process development, scale-up, and tech transfer activities.
Conduct forced degradation and impurity profiling studies for oncology drug candidates.
Ensure all analytical work is compliant with
GLP/GMP
and applicable regulatory requirements.
Troubleshoot analytical challenges and provide technical guidance to junior team members.
Interface with QA, Regulatory Affairs, Formulation Development, and Manufacturing teams to ensure seamless project execution.

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