Girish Kapur

 Site Head for 3 locations at Hyderabad, India (Director and Board Member,India)  Member, Global Leadership Team of USP-https://www.usp.org/about/leadership  Advisor-Diversity, Inclusion and Belonging, Global Strategic Initiative  Sponsor-Global Women Network - USP India  Member of Agile Leadership, Strategy and Operations Working Group SKILL SET SUMMARY (Technical /Leadership /People Manager /Strategic) Personal Effectiveness Project Management Impact and Influence People Development Strategic Thinking Operational Excellence Quality and Compliance Risk Management Financial Planning Problem Solving & decision making Manage external interfaces

Head, Drug Product Analytics Core member of Global Analytical R&D Leadership team (GARD-LT ) Core member of Novartis R&D site technical board for recruitment of talent Core member of Novartis India Grievance Redressal Committee(GRC) Core member of Site Review Board (SRB) Lead a Technical Development Team responsible and accountable for analytical activities (method development, method validation and technology transfer) for products under multiple therapeutic segments Team Size: ~50+, NCE’s portfolio – 40+ nos.(Early and Late Phase) Contribute to definition and implementation of the global line function strategy and ensure both strategic and operational objectives are met. Drive within the global line function leadership team to ensure optimal allocation of projects, people, assets,equipment in order to best serve project needs. Ensure that all deliverables are achieved with committed resources for development and life cycle management projects Responsible for ensuring financial spend remains in line with Global ARD budget. Ensure high quality and timely preparation of documents for regulatory submissions. Develop and maintain best-in-class partnership with vendors and service providers. Strive for operational excellence by ensuring continuous improvement of processes. Ensure and be accountable for delivery in compliance to all relevant standards (e.g. HSE, GMP, ISEC), corporate, legal guidelines and quality requirements. Effectively manage the interface between the team and stakeholders in other functions within and outside of Technical R&D Direct people management responsibility for all team associates in collaboration with supporting roles in the team.

Team Lead, Late Phase Portfolio and Head, Operations(PHAD IN)

Team Lead ,Late Phase Portfolio.

Core Member of Global Pharmaceutical Sciences Leadership Team (PSLT) - Pfizer Core member of Manager Talent Advisory Committee (M-TAC) to carve and implement charter for Manager Development Lead and represent analytical function at various internal and external forums for scientific, strategic and financial decision making process Heading a team of Analytical Scientists at Pfizer Pharmaceutical Sciences R&D centre ,responsible and accountable for NCE development ,transfer to manufacturing and CMC filing of NADA,NEB’s,LCM’s ( API and Formulation ) for regulated markets (US,EU) as per VICH guidelines Pharmaceutical Sciences Team Leader ( PSTL) for project teams with members from diverse functional areas ( QA,Regulatory ,Clinical ,Supply Chain,Manufacturing and Marketing) Lead and manage QC function involved in GMP testing , release and stability of raw materials and finished products (Solids ,Liquid and Sterile Dosage Forms) Batch Release – Clinical Supplies, Pilot Plant Batches, Scale Up lots of DP

Led a team of scientists for guidance and direction for analytical activities related to ANDA's ( including Para-IV FTF ) as per ICH guidelines Major activities included but not limited to Excipient compatibility studies,Innovator Characterisation,Discriminatory and Bio relevant Dissolution studies, Batch analysis and Release for Pilot and Pivotal Bioequivalence stduies,Pilot and Method Development,Method Validation,Stability Studies(including Photostability and Freeze Thaw experiments ) Accountable for co-ordinating technology transfers (Inter-Lab-Qualifications) to manufacturing locations across the globe (Markets :US,EU) Dosage Form handled:Solid Orals,Liquid Orals ,Suspensions,Parenterals,Topicals Created and implemented processes for effective utilization of available resources (Men ,Machine and Materials) thereby increasing efficiency and productivity Lead ,coordinate and resolve any queries arising during Technology Transfers to manufacturing locations in india and abroad Core member of the team for preparation of audits at all manufaturing locations Creation and revision of SOP's (Systems,Processes, Equipments) Respond timely to regulatory queries pertaining to regualted markets(US and EU) Represent analytical function in Product Review committees(PRC) on regular basis and propose alternatives to accelerate the overall filing process . Actively participate in Cross Functional teams (CFT) for various Para IV projects to review and assess progress .