Aditya Jondhale

Quality Control Officer @Serum Institute Of India Pvt. Ltd

Pune, IN

Led ELISA-based antigen quantification and potency analysis for HPV vaccine batches, supporting criticaldecision-making for batch release.• Performed biochemical profiling including carbohydrate/lipid quantification and detection of host cell DNA & residual proteins, ensuring bioproduct purity and safety.• Oversaw ED50-based ELISA immunogenicity studies in laboratory animals, evaluating immune responsepotency and dose-response relationships.• Ensured full GMP compliance across vaccine stability chambers, cold chain storage, and quality oversightoperations.• Executed HPLC assays for related substances, purity analysis, and active pharmaceutical ingredientquantification, with method optimization and validation.• Directed instrument calibration, preventive maintenance, and performance qualification for analyticalplatforms including ELISA readers, HPLC systems, incubators, and stability chambers.• Managed batch release workflows and coordinated documentation with the Central Drug Laboratory(Kasoli) for approval and licensing.• Authored and reviewed GMP documents: SOPs, Master Test Requirements (MTRs), validation protocols,datasheets, and stability reports, aligning with EU ALCOA+ data integrity standards.• Supervised sample lifecycle management, including inward receipt, outward distribution, and transfer ofHPV vaccine-related samples across cross-functional QC labs — Microbiology QC, Raw Material QC, andStability QC. Ensured traceability and temperature integrity during inter-lab movement under GMP protocols.Coordinated sample tracking via LIMS and maintained compliance with QMS standards.

College of Agricultural Biotechnology, Loni-Pravara

B.Tech, Biotechnology