Association for Accessible Medicines
601 New Jersey Ave NW, Suite 850
Washington, DC 20001
E: [email protected]
Anupama is a biosimilars development proficient. In her current role she heads program management office for Quality function. Project planning, monitoring, and reporting of routine operations, development products testing & Regulatory inspections are under the scope of her role. 17 years of Biosimilars:
• Process development of G-CSF and PEG G-CSF
• Analytical method development for PEG G-CSF, mAbs and Insulins
• Global Regulatory Lead (GRL) for rHI
• Portfolio & Alliance management of Insulins
• Quality function PMO
In her tenure at R&D, Anupama developed CMC expertise from hands on purification process development and analytical method development. Developed analytical similarity packages for biosimilar products at Biocon Biologics. In her role as Global Regulatory Lead for rHI program, Anupama spearheaded BPD meeting request packages (type-2 & type-3). She also played instrumental role in drafting BLA dossier. Anupama decided to move to business aspects of biosimilars and played a role of program & alliance management for Insulins portfolio. She is now heading PMO for the Quality function focused on QMM, operational excellence and site readiness for Regulatory inspections.
She holds a bachelor’s degree in Genetics & Biochemistry and a master’s degree in Biotechnology from Bangalore University, India.
Anupama is a blend of strong technical and management skills. She is appreciated for her planning, time management, assertive communication, and leadership skills.