Namrata Ramakrishna Shastri

• Expert in analytical method development and qualification for the purification and separation of monoclonal antibodies, biosimilars, and excipients, utilizing HPLC, CE-SDS, and other advanced analytical and characterization tools to ensure precision and regulatory compliance.
• Ensured compliance with International Council for Harmonisation (ICH) guidelines in analytical procedures, and wrote a technical report as needed according to compliance requirements.
• Reviewed and approved the method development report, method validation/qualification protocols, transfer protocols, and associated reports for both Research & Development (R&D) and Quality Control (QC) facilities. Ensured adherence to industry standards and regulatory requirements.
• Conducted a thorough data review and prepared analytical similarity documentation for the FDA, EMA, and Japan, as well as ROW submissions, ensuring compliance with global regulatory requirements.
• Managed R&D documentation, ensuring proper specification management for raw materials, intermediates, and finished products. Maintained data integrity in compliance with GMP and GLP standards.
• Verified laboratory compliance through the investigation and reporting of change control, deviation, out-of-specification (OOS) results, and Inter Office Memo (IOM). Implemented corrective actions as necessary.
• Managed team to ensure effective communication and collaboration leading to successful project milestones.
• Guided new employees through essential practices in analytical methods and quality management systems.
• Oversaw the implementation of Viatris acquisition and established supply chain management for the European market, coordinating activities in Ireland.
• Directed strategies to lower manufacturing costs and improve quality standards for key drugs such as Bevacizumab, Pertuzumab, Trastuzumab, and PEG-GCSF.
• Publication: Analytical similarity assessment of MYL-1402O to reference Bevacizumab.

https://doi.org/10.1080/14712598.2021.1973426

• Design of experiments in plasma protein purification, column chromatography using monolithic supports
• Administrative responsibilities: inventory management, coordination with vendors for procuring consumables, preparation of periodic reports

• Development and Qualification of HPLC-UV Methods for monitoring related substances of Protein Pharmaceutical products, with particular focus on Data integrity and traceability aspects
• Data traceability & data evaluation for HPLC and UV based methods & HPLC set up for different methods