This is a key hands-on, non-supervisory position. In this role, the Scientist initiates and executes stability studies for reference standards using appropriate compendial methods. Additionally, the incumbent will be responsible for performing analytical method development and validations for Impurity RS and maintaining safety and GLP environment in the lab.
Experience of formulation plant and knowledge of GLP & GDP. Should have knowledge of Microbiological testing, Environmental monitoring, Water system analysis, HVAC validation, QMS
Ensures that justified extension requests are made before the investigation deadline and that the investigations and CAPAs are closed within the required timeframe. Acts as a guardian of metrics by carrying out periodic follow-ups regarding investigations and CAPAs opened with internal and external partners.
Candidate having experience of Bio-similar product manufacturing. Large scale bioreactor, Continuous centrifuge
Trouble shooting, risk assessment, root cause analysis.
UNDERSTAND DESIGN, SETUP, AND EXECUTION OF IN VIVO PHARMACOLOGY MODELS FOR EXPERIMENTS ASSOCIATED WITH GROSS IMMUNOLOGY, SOLID TUMORS, AND HEME-ONCOLOGY