Specialist, Regulatory

3 days ago


Hyderabad, Telangana, India Aurigene Pharmaceutical Services Limited Full time
Job description Analytical Specialist to support analytical development and testing activities within a Contract Development and Manufacturing Organization (CDMO) environment. The role requires expertise in analytical method development, validation, structural characterization, elucidation, impurity profiling, impurity identification and troubleshooting for drug substances (APIs) and its intermediates, while effectively managing multiple client projects, timelines, and regulatory expectations. Serving as a mentor to junior team members. Proficient in interpreting analytical data and making informed decisions for the project.

Key Responsibilities:

Analytical Development & Validation

Develop, optimize, validate, and
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