Hari Prakash Chanumolu
Quality Associate @ Moderna | Regulatory Affairs
- Role
- Quality Associate Ii at Moderna
- Location
- Somerville, MA, US
- LinkedIn followers
- 500 followers
About Hari Prakash Chanumolu
Moderna benefits from my role as a Quality Associate, where I contribute to ensuring…
Experience
Quality Associate Ii
Apr 2024 — Present · Noorwood, MA, US
Developed and optimized in vitro assays to assess product stability, cellular response, and assay reproducibility, contributing foundational skills toward immune functional assay development. Collaborated with cross-functional R&D teams to validate bioanalytical methods, ensuring high-throughput data generation for biologics under development. Participated in the review and validation of cell-based assays, supporting SAR and MoA studies for early-stage therapeutic candidates. Supported cytokine quantification and biomarker analysis using ELISA-based platforms and multiplex assays as part of QC release testing for biologics. Performed Western Blotting and RT-qPCR to evaluate target expression levels and product consistency across production batches. Contributed to development and standardization of SOPs and lab protocols, enhancing the lab\'s throughput, reproducibility, and regulatory compliance. Generated and analyzed experimental data using GraphPad Prism and Excel, preparing comprehensive technical reports and presenting findings to cross-functional teams. Partnered with R&D Scientists to investigate target expression and pathway modulation as part of quality release criteria for immunotherapy candidates. Ensured accurate and timely data reporting in line with GMP/GLP standards, supporting critical decision-making in early drug development.
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