Dynamic and result-oriented Pharmaceutical New Product Launch Operations Project Management Leader/Assistant General Manager with 20+ years of proven success in managing end-to-end new product launches, biologics manufacturing, and global supply chain operations
Adept at driving complex product introductions (OSD, Injectables, Topicals) across regulated markets (US, EU, RoW), with deep expertise in Formulation Products Launch Operations, project management, cross-functional teams, and CMO strategic alliance management
Track record of managing complex, multi-site product launches with full ownership from development to commercialization, including strategic alliance & contract management, compliance oversight, and product lifecycle management
Demonstrates sharp business acumen in integrating Lean Delivery Methodologies (LDM) with cross-functional execution strategies to meet customer-centric project management of new product launch timelines and regulatory compliance goals
Brings a strong technical background in Formulation Projects, biologics, fermentation, peptide purification, and vaccine manufacturing, coupled with hands-on leadership in development QA, technology transfers, and global supply chain operations mgmt
Expert in leveraging Lean methodologies and project governance frameworks to accelerate time-to-market, while aligning operational goals with corporate strategy
Recognized for building high-performance teams, navigating complex stakeholder environments, and delivering strategic value through operational excellence and continuous improvement
Strong command over ANDA filing processes, scale-up execution, validation, and regulatory compliance
