Planned and executed PK-PD assay method development/validation and non-clinical/Phase I/Phase III studies within timelines and budgets.• Supervised end-to-end study sample analysis and method validation of PK/PD projects, ensuring timely reporting of results.• Established new method development and assays for mAbs (Denosumab, Bevacizumab, Ranibizumab, Pertuzumab, Trastuzumab, Vedolizumab) and therapeutic proteins (PTH, Romiplostim).• Conducted data analysis, interpretation, and troubleshooting of analytical challenges.• Drafted and reviewed study plans, method SOPs, validation reports, and bioanalytical reports.• Managed and mentored team members, ensuring compliance with GLP and GCP standards.• Participated in regulatory inspections and facilitated responses to audit queries.• Developed robust analytical models and risk assessments, enhancing research quality and reliability.

Mentored junior researchers, contributing to their professional growth and development.• Developed innovative research methodologies and conducted thorough literature reviews.• Led method development, validation, and study sample analysis for clinical and non-clinical studies.• Managed project-specific inventory and ensured compliance with GLP and GDP standards.• Supported software validations and assisted with archival and reconciliation of project data.

• Streamlined data collection and analysis processes, enhancing research efficiency.• Performed method validation and study sample analysis according to SOPs.• Maintained inventory and calibrated laboratory instruments in compliance with GLP.• Participated in SOP preparation and communicated project status to stakeholders.• Utilized advanced statistical techniques for data analysis, uncovering significant trends and correlations.