Nethra S Pmp® Email and Phone Number

Biosimilars-Bioassay:-Lead the development and validation of Bioassays in compliance with regulatory guidelines.-Reviewing scientific documents like Technical report, method development and validation reports, tech transfer reports and regulatory dossiers.-Biosimilar stability study, forced degradation study, immunogenicity risk assessment studies and analytical similarity assessment.-Budgeting, work forecasting, planner preparation, resource management, vendor assessment, inventory management and risk assessment for all bioassay projects. -Scientific data generation, interpretation and recording by using many scientific applications like soft max pro, graph pad prism, gen 5 and ELN/LIMS.-Part of 3 BLA submissions by generating analytical similarity data, review of relevant sections of regulatory submissions and support in addressing technical queries from various regulatory bodies for biosimilars.-Handling change controls, deviations and implementing CAPA’s and many more QMS related documents.-Data presentation and communication with internal and external stakeholders of all inhouse and outsourced methods.-Provide mentorship, training and guidance to associate level staff and contribute to their development.

Antibody development and project management.-Lead the upstream module (ExpiCHO and Expi293) for monoclonal and oligoclonal antibody production.-Antibody titer check using Indirect ELISA and western blot.-Method development for Stable cell line generation of ExpiCHO-S cells.-Development and standardization of small scale antibody production system using different cell lines like ExpiCHO, Expi293 and HEK293.-High throughput method development for selection of high titer Ab producing clones and sera.-Support antibody launch process by collaborating with internal and external stakeholders.-End to end project management. (Includes antigen design support, materials ordering, budgeting, tracking the project flow in different modules, risk assessment, risk mitigation etc...).-Antigen conjugation to support downstream process on polyclonal antibody purification.-Tech transfer from R&D to manufacturing.

Drug Discovery-Metabolic disorders and fibrosis.-Bioassay development for target drug screening.-Cell model development to mimic the metabolic and fibrotic condition.-Part of target identification team.-Handling of cell lines, cell banking, culture and characterization.-Developed and screened target molecules using cell and tissue based assays by using ELISA's, gene expression (RT-qPCR), western blotting, HTRF .-Development of high throughput methods for identifying mode of action and screening of target compounds.-Project planning, execution and collaboration with internal and external stakeholders.

- Responsible for Raw material and finish product analysis in compliance with Indian and European pharmacopeia. -Facilitating the internal and external auditing.- Release document preparation and review.