Analytical Scientist/ Scientist

Job Summary

Brief team/department description:

The analytical team at R&D is playing an important role in product development of various dosage forms. The analytical team involves different workflows like analytical method development, stability studies, involving method verifications at CMO/CTL and post filling activities.

This role is with Azurity R&D Analytical Scientist, which required to work in product development team s analytical method development, Formulation sample analysis, method verification, Compendial method evaluation, Stability sample analysis and instruments calibrations.

Principle Responsibilities

• Follow Good documentation practices
• Execution of analytical method development of Nitrosamine impurities using high end instrument and method validation parameters for developed method.
• Execution of analytical method development for unknown impurity and Genotoxic impurity identification using HPLC-PDA/UV/ELSD and LCMS techniques.
• Ensuring all documents and data for adequacy, accuracy, and completeness during the execution and documentation.
• Execution of Formulation developmental samples analysis as per ATR, recording of online documentation and completion of the analysis on time.
• Adhere to current GLP procedure, data integrity and meeting SOP compliance requirements.
• Development of Analytical methods using different analytical techniques, method verification of compendial methods, verification of Drug substance test methods.
• Follow the safety procedure in the laboratory.
• Should have exposure in preparing the STP, MDR, MOA for the allocated products.

Qualifications and Education Requirements

• Postgraduate in Pharmacy or Science.
• minimum 3 years of experience in pharmaceutical analytical R&D handling of LCMS instrument under this category.
• Well versed with analytical method development of Nitrosamine impurities in DS, DP and Excipients.
• Knowledge of unknown impurity identification using LCMS technique in DS, DP in Pharmaceutical Research and Development.
• Understating Good Laboratory Practices and Good Document Practices.
• Should have knowledge /exposure to electronic eLN/DMS systems.
• Proficient in written and spoken English.

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