Sri Krishna Yasaswi Maddirala

Sr Scientific Manager @Aragen Life Sciences

Hyderabad, IN

Strategically leading, coordinating, and overseeing R&D initiatives, providing critical guidance, and recommending essential improvements to drive innovation and results Directing and inspiring a team of chemists and scientists in the design and execution of experiments, ensuring excellence in method development and validation Guiding and developing fellow scientists by providing expert mentorship and training in diagnosing and resolving equipment issues and experimental challenges Driving and overseeing all aspects of method development, validation, verification, and transfer for APIs and drug products to ensure robust & compliant analytical processes Ensuring full compliance with cGMP standards by rigorously meeting regulatory audit requirements and maintaining meticulous documentation Supervising a wide range of functions, including:o Planning and executing analytical method validation protocols, reports, test methods, and specificationso Managing post-authorization activities such as revisions and change control for approved test methods and specifications Contributing to the identification and selection of API vendors, while leading the planning and execution of stability sample analyses to determine product shelf life following ICH guidelines