Analytical R&D(API) - Mass Spectrometry

Role & responsibilities

Mass Spectrometry-Based Characterization

• Perform structural characterization of APIs, intermediates, impurities, degradants, and unknown compounds.
• Conduct impurity identification and root cause investigations using advanced mass spectrometric techniques.
• Support forced degradation studies, stability investigations, and extractables/leachable assessments.
• Develop and optimize MS methods for qualitative and quantitative analysis.
• Perform molecular weight confirmation, fragmentation pathway analysis, and elemental composition determination.

Analytical Techniques

Hands-on operation, troubleshooting, method development, and interpretation of data generated using:

Liquid Chromatography-Mass Spectrometry

• LC-MS/MS
• UPLC-MS/MS
• LC-HRMS
• Q-TOF MS
• Orbitrap HRMS
• Triple Quadrupole MS
• Ion Trap MS

Gas Chromatography-Mass Spectrometry

• GC-MS/MS
• GC-QqQ
• GC-HRMS (preferred)
• Headspace GC-MS

Technical Support

• Investigate unknown peaks, impurities, degradation products, and process-related contaminants.
• Interpret fragmentation pathways and propose structures based on accurate mass measurements.
• Identify genotoxic impurities, residual solvents, and trace-level contaminants.
• Characterize metabolites and transformation products using HRMS techniques.
• Generate comprehensive characterization reports integrating LC-MS/MS, HRMS, GC-MS/MS, and complementary analytical data.
• Support method troubleshooting and analytical problem-solving activities.