Indhumathi M Email and Phone Number

Product Analytics• Independently analyzed, optimized, developed, transferred, and qualified analytical methods for biosimilar and bio fusion molecules (mAbs), including RP-HPLC, SEC HPLC, IEX HPLC, Protein A HPLC, CE-SDS, CZE, Peptide Mapping by HPLC and UPLC, Sialic Acid and N-Glycan by HPLC and UPLC.• Involved in digitalizing sample analysis data by creating and implementing templates for dashboards.• Skilled in investigative analysis methods and ensuring compliance with… Show more Product Analytics• Independently analyzed, optimized, developed, transferred, and qualified analytical methods for biosimilar and bio fusion molecules (mAbs), including RP-HPLC, SEC HPLC, IEX HPLC, Protein A HPLC, CE-SDS, CZE, Peptide Mapping by HPLC and UPLC, Sialic Acid and N-Glycan by HPLC and UPLC.• Involved in digitalizing sample analysis data by creating and implementing templates for dashboards.• Skilled in investigative analysis methods and ensuring compliance with regulatory standards.• Designed, planned, and executed stress stability studies (including pH, thermal, agitation, and oxidation stress) to assess the impact on product stability in accordance with quality and regulatory compliance standards.• Deliver timely and comprehensive written documentation, including laboratory notebooks, SOPs, and development and qualification protocols/reports, as well as provide effective oral communications to both internal and external stakeholders. Show less

Analytical R&DWorking at developing, qualifying and transferring the pharmaceuticals large molecules like mAbs-IgG, IgM and enzymes of raw materials and stability studies.• Independently develop/optimizing, identifying and determining the analytical methods to characterize protein/antibody by HPLC, UPHLC, Spectroscopy, SDS PAGE, CE-SDS, ELISA, Cell-based bioassay methods.• Capable of troubleshooting the analytical instruments and involved in root cause… Show more Analytical R&DWorking at developing, qualifying and transferring the pharmaceuticals large molecules like mAbs-IgG, IgM and enzymes of raw materials and stability studies.• Independently develop/optimizing, identifying and determining the analytical methods to characterize protein/antibody by HPLC, UPHLC, Spectroscopy, SDS PAGE, CE-SDS, ELISA, Cell-based bioassay methods.• Capable of troubleshooting the analytical instruments and involved in root cause investigations.• Deliver timely and comprehensive written Laboratory notebooks, SOPs, Development and qualification protocol/Reports & Oral communications to both internal and external stake holders. Show less

Analytical R&D•Worked at developing, qualifying and transferring the pharmaceuticals large molecules like mAbs-IgG, IgM and enzymes of raw materials and stability studies.• Independently develop/optimizing, identifying and determining the analytical methods to characterize protein/antibody by HPLC, UPHLC, Spectroscopy, SDS PAGE, CE-SDS, ELISA, Cell-based bioassay methods.• Capable of troubleshooting the analytical instruments and involved in root cause… Show more Analytical R&D•Worked at developing, qualifying and transferring the pharmaceuticals large molecules like mAbs-IgG, IgM and enzymes of raw materials and stability studies.• Independently develop/optimizing, identifying and determining the analytical methods to characterize protein/antibody by HPLC, UPHLC, Spectroscopy, SDS PAGE, CE-SDS, ELISA, Cell-based bioassay methods.• Capable of troubleshooting the analytical instruments and involved in root cause investigations.• Deliver timely and comprehensive written Laboratory notebooks, SOPs, Development and qualification protocol/Reports & Oral communications to both internal and external stake holders. Show less

• Provided research and technical support with the upstream team on multiple projects.• Monitored cell cultures and harvest via Distributed control system.• Performed cell vial thaw, transferred to cell cultures flasks and bioreactor. Involved in tech transfer and scale up activities and documentation.