Phonnavan G Email & Phone Number

Chennai, Tn, In

Chennai, Tamil Nadu, India

• Nitrosamine Detection Method Development: Developed and validated LC-HRMS and HPLC methods for detecting nitrosamines in drug products.• Monoclonal Antibody Characterization: Characterized monoclonal antibodies using advanced techniques like peptide mapping, subunit, and intact analysis.• Unknown Peak Identification: Identified and characterized unknown peaks in drug products using LC-HRMS.• Cross-Functional Collaboration: Partnered with Cross-Functional teams to implement nitrosamine testing for all drug products and resolve complex issues.• Market Compliance Support: Provided analytical support for market compliance samples, including method development, validation, and sample analysis.• Technical Transfer & Troubleshooting: Transferred analytical methods and technologies, supported market compliance samples, and implemented nitrosamine testing, ensuring seamless adoption and compliance

Chennai, Tamil Nadu, India

• Stability Study Oversight: Managed stability studies, handled deviations, change control, and CAPA related to stability chambers and studies.• Protocol Development: Prepared stability study protocols, photo stability study protocols, and stability study summary reports for ANDA submission.• Data Quality & Integrity: Ensured data quality and integrity, identifying and resolving discrepancies and issues

Chennai

• Product Analysis: Analysed intermediate and finished drug products from exhibit and commercial batches to ensure quality and purity.• Validation Study Analysis: Analysed samples from process validation, cleaning validation, and hold time studies to support regulatory submissions.• Quality Control Review: Conducted quality control reviews of HPLC analytical data to ensure accuracy, precision, and compliance with regulatory requirements.