Kalyani Pemmaraju | Director - Operations (Formulation, Fill/Finish and Packaging), External Supply and Manufacturing
AstraZeneca
- Kalyani is a biopharmaceutical professional with 30 years of experience in various aspects of biologics, such as CMC development, CMC regulatory, large-scale manufacturing, launch and commercialization. She worked across multiple therapeutic areas (Immuno-Oncology, Hematology, Respiratory, Inflammation, Autoimmune and Infectious Disease) steering biologics and combination products from conception through to commercial success.
- Kalyani has a strong foundation in science and brings comprehensive knowledge and hands on experience in the development of biologics and combination products. Her focus for the past 10 years has been dedicated to mastering the intricacies of operations and supply chain management for biologics and combination products. She has in-depth experience working with internal and external manufacturing sites and end-to-end supply chain nodes. She is adept in optimizing supply chains, mitigating operational risks, swiftly adapting to changes effectively and is committed to operational excellence and strategic agility.
- As a front-line leader Kalyani is recognized for driving strong performance and delivering successful outcomes in dynamic and complex matrix environments. Her leadership approach is characterized by building trust, listening carefully, empathetic engagement and clear delineation of objectives and expectations, ensuring sustained organizational growth and success. She thrives in mentoring roles, thoroughly enjoys coaching peers and guiding cross-functional teams and nurturing talent.
- M.S. in Biotechnology, Johns Hopkins University, Baltimore USA
- M.S. in Applied Microbiology (With a concentration in Immunology, Hematology, Medical Microbiology, Virology, Genetic Engineering, and Industrial Microbiology) Padmavathi University, India
- B.S. (Major in Microbiology, Chemistry and Zoology) Osmania University, India
- CSCP (Certified Supply Chain Professional – APICS) – Since 2016
- PMP (Project Management Professional – PMI) – Since 2014
- US RAC (United States-Regulatory Affairs Certification – RAPS) – Since 2011
Appearances:
Festival of Biologics Day 2 @ 11:45
Operational Excellence in Drug Development and Supply Chain Management
- Operational Excellence in Drug Discovery Supply Chain Management" is structured to provide a comprehensive overview of how operational excellence drives efficient, resilient, and high-quality processes across the pharmaceutical value chain—from drug discovery to commercialization. The discussion opens with a focus on Operational Excellence (OpEx) in the context of drug discovery, development, and commercialization, emphasizing its pivotal role in enhancing quality, productivity, and innovation throughout the product lifecycle.
- Real-world case studies, such as the supply chain maps for Fasenra and Imfinzi, will illustrate the practical application of OpEx principles in managing the complex logistics and regulatory requirements of life sciences products. The summary then explores the core principles underpinning operational excellence, including continuous improvement, process standardization, and value creation, as well as the importance of robust business process management.
- A detailed review of the tools and techniques used to achieve operational excellence will be provided, encompassing methodologies such as Lean, Six Sigma, and digital enablement. This will be supported by further examples highlighting successful operations and supply chain initiatives, demonstrating how OpEx concepts translate into measurable performance improvements. The agenda also addresses how to navigate volatile, uncertain, complex, and ambiguous (VUCA) environments, reflecting on the need for agility and adaptability in current global supply chains. Finally, the role of people and culture in underpinning operational excellence will be considered, highlighting the importance of leadership, cross-functional collaboration, and a continuous improvement mindset.
Festival of Biologics Day 3 @ 12:30
CMOs as Strategic Partners: The Evolving Landscape of Fill-Finish in Commercial Biologics
As the commercial biologics landscape grows increasingly complex, fill-finish Contract Manufacturing Organizations (CMOs) have become critical strategic partners in ensuring product quality, supply continuity, and speed to market. This presentation will explore the evolving role of CMOs in commercial biologics manufacturing, highlighting key trends, emerging technologies, and operational challenges. Drawing from real-world experience, the talk will examine best practices for building resilient, collaborative partnerships with CMOs and provide strategic guidance on navigating capacity constraints, regulatory expectations, and global supply chain risks. Attendees will gain practical insights into how to future-proof their fill-finish strategies in an ever-changing environment.
last published: 01/Aug/25 16:05 GMT
Created by
Terrapinn is proud to be a member of isla.
Working together to build sustainable events