Madhavi Adusumilli

Manager

Biological E. Ltd.

Hyderabad

11.2016 - Current

Handling of Pneumococcal conjugate vaccine (14 valent & 24 valent), HPV and Polyoma vaccine projects
Supervised a team of three members and facilitated the juniors from cross functional teams on handling of equipment
Design of DOEs for the development of chromatographic methods (ICS, SEC-MALS & CE) to study the vaccines
Optimization of ELISA kit-based methods for impurity profiling (residual host cell proteins and host cell nucleic acids)
Preparation and review of the method development reports of all analytical methods
Pre-validation of analytical methods for product characterization and successful transfer of methods to QC
Assign and supervise the day-to-day lab activities and summarize the analytical results
Review to check the data integrity and ensure all experimental analysis are carried out as per GLP guidelines and review of LNB
Have knowledge on analytical requirements for manufacturing clinical batches and RCGM filing
Preparation of STPs, SOPs, protocols, reports, URS and SLIA
Preparation of In-house reference standards (IHRS) based on the requirement
Have knowledge on Document Management System (DMS), Learning Management System (LMS) and change controls
Responsible for release of COAs for the Pneumococcal Conjugate Vaccine at Drug Product stage and Polyoma VLPs at Drug Substance stage
Maintenance, calibration and troubleshooting of equipment/Instruments –HPLC, SEC-MALS, DIONEX, CE, Nitrogen Evaporator, Milli-Q System
Ensure & manage the resources including raw materials required for the projects as well as involving in the CAPEX discussions
Supporting upstream and downstream process team in optimizing their process.