ARD Chemist/ Scientist

Job Title:

Location:

Job Summary:

We are seeking a motivated and detail-oriented individual to join our ARD team. The candidate will be responsible for method development and validation, impurity profiling, and instrumental analysis to support our Synthesis R&D and quality operations.

Key Responsibilities:

1 Method Development & Validation

• Develop HPLC, GC, and LC-MS analytical methods for monitoring in-process reaction samples from the Synthesis R&D team.
• Develop and validate HPLC methods suitable for AMV (Analytical Method Validation) and transfer to QC.

2 Impurity Profiling & Characterization

• Perform impurity profiling of APIs and intermediates.
• Identify and characterize impurities using advanced techniques like mass spectrometry.

3 Instrument Handling & Calibration

• Ensure all analytical instruments (HPLC, GC, LC-MS, etc.) are maintained in optimal working condition.
• Perform regular calibration and documentation of analytical instruments.

4 Documentation & Compliance

• Maintain proper records as per regulatory and internal quality standards.
• Support preparation of SOPs, protocols, and technical reports.

Key Skills Required:

• Strong knowledge of HPLC, GC, and LC-MS techniques
• Experience in method development and impurity profiling
• Familiarity with ICH guidelines and regulatory requirements
• Proficiency in analytical software like Empower/Chromeleon
• Good documentation and communication skills