Sagar Shakya

I have worked on manufacturing processes for small molecule drug substances (DS) or active pharmaceutical ingredients (API) processes at preclinical, Phase I, Phase II, Phase III stages of development and the commercialization stage. This includes route selection, phase appropriate scale up, process characterization (establishing acceptable processing ranges, fate and purge studies to set specifications), process validation (or process performance qualification PPQ), and commercial manufacturing. I have embraced department and corporate goals and driven the team to achieve them. As an experienced Chemistry, Manufacturing and Controls (CMC) leader I collaborate well with other functional areas, and I have worked with several structurally complex APIs for different indications targeted to treat patients. Applying synthetic chemistry and regulatory knowledge to drug development programs is very intellectually rewarding since it ultimately helps with patient care. I have led and participated in several CMC teams and collaborated well with various functional area team members as well as team members at CROs/CMOs. I am passionate about contributing to the benefit of patients and organizations involved in such activities. Let’s connect to discuss ways I can contribute to your success!