SANDEEP SHANTHARAM

• Developed and executed chromatographic and spectroscopy methods for protein content estimation in whole cell broth samples from yeast and fungal sources
• Designed and supervised stability studies for in-house product IRS qualification, ensuring compliance with market standards
• Supported upstream and downstream teams with regular sample analysis and facilitated method transfer activities to CMO sites
• Led pre-validation of two in-house methods, including report writing and closure in accordance with quality requirements
• Collaborated with the strain team on UPLC method development for deep well plate samples and coordinated with the engineering team for HPLC/UPLC maintenance and PM activities
• Interpreted and presented analytical data to stakeholders, ensuring clear communication of findings
• Conducted regular lab maintenance, including instrument calibration, troubleshooting, and performance qualification
• Participated in internal lab audits, managed deviations, and prepared SOPs, protocols, and technical documents
• Generated protein assay and stability data for FDA-GRAS filing requirements.

• Executed and supervised HPLC / UHPLC Method development, method qualification, sample analysis of Insulin Analogues mainly RP, IEX and SEC
• Executed stability studies like Force degradation, Freeze thaw of the DS and DP w.r.t protocol and report preparations as per ICH guidelines
• Executed Analytical similarity assessments for new Biosimilar filing including different mass spectroscopy techniques
• Responsible for method transfers and performing method transfer activity
• Responsible for generation of QTPP data for ranges with different sources of the molecule which assist in deriving acceptance criteria for bio-similarity studies and supporting filings
• Responsible for addressing queries, updating the stability data and COA preparation as per the regulatory requirements for agency submissions
• Study initiations, sample pull-outs, with data trending and timely report closures which supported the CTA filings
• Responsible for preparation, updating & reviewing of SOP's, MDRs, MQPs, MQRs, amendments for the existing studies, & all other related documents
• Impurity profiling and characterization through mass spectrometry analysis including but not limited to Intact mass, Reduced mass and PMF analysis
• Data compilation using statistical tools, discussion with CFTs within R&D, QC and manufacturing site.

QUALITY

· Preparation and review of SOPs that are relevant to GDP and analytical quality system.

· Responsible for timely reporting and closure of deviations, OOS, OOT and incidents support in the quality data generated for the smooth batch releases.

· Deviation, change management and CAPA management through TRACKWISE.

LAB MANAGEMENT

· Supporting Installations and calibration activities of analytical instruments, performing and taking care of activities assigned as part of laboratory management.

· Assisting the vendors in the new installation Planning and maintaining inventories of chemicals and consumables required for project.

• Developed and qualified analytical methods for the purification and separation of insulin analogues, monoclonal antibodies, and excipients using HPLC and other analytical techniques
• Led analytical method transfers and investigations for pilot plant facilities, and supported the preparation of analytical similarity/QTPP reports for global product submissions
• Conducted troubleshooting for product-related and analytical methods, supporting end users in resolving issues
• Estimated protein impurities and identities using RP-HPLC, SE-HPLC, and salt-based methods; planned and executed experiments in response to specific queries
• Analyzed in-process samples, drug substances, drug products, and stability samples for insulin and its analogues utilizing various biochemical techniques
• Performed stability, stress, and forced degradation studies of proteins in compliance with ICH guidelines
• Authored technical reports, method validation protocols, and transfer documents, ensuring compliance with regulatory requirements
• Managed and presented analytical data to stakeholders, customers, and end users, ensuring clarity and actionable insights
• Operated, maintained, and calibrated HPLC/UPLC/UHPLC systems, including Agilent, Waters, and Shimadzu models
• Developed methods for quantifying monoclonal antibody excipients and process-related additives such as polysorbates, amino acids, and sugars
• Maintained compliance with ICH guidelines, GMP, 21CFR part 11, GLP, and GDP, and supported R&D documentation and specification management.

• Shadowed daily activities of office staff, gaining understanding of [protein estimation and characterization]
• Assisted in the setup, calibration, and validation of chromatographic systems, including HPLC and UHPLC, ensuring accurate and reliable performance
• Prepared and standardized various buffers and solutions used in chromatographic procedures, adhering to established protocols and maintaining consistency
• Conducted systematic sample collection from various sources, ensuring proper labeling, documentation, and storage for subsequent analysis
• Organized inventory and labeled products appropriately
• Determination of surface hydrophobicity using UV spectrometer and Fluorescence spectrometer for Insulin Analogues
• Impurity characterization by LCMS/MS (MALDI-ToF) and Method development to identify the molar extinction coefficient based on industry standard procedure at Characterization Development Lab (CDL).

• Supporting ongoing experiments related to enzyme development and enzyme applications
• Preparing and processing samples for analysis, including enzyme assays, viscosity, density and biochemical tests
• Preparing buffers, reagents, and solutions used in enzyme assays and other laboratory activities
• Assisting with routine maintenance of laboratory equipment and ensuring a clean and organized work environment
• Championed adherence to company policies with meticulous attention to detail
• Worked on Enzymatic Oil Extraction and Enzyme applications for developing the efficient oil extraction process.