Dharmesh Ojha

Background

About Dharmesh Ojha

I am a visionary pharmaceutical leader with over 22 years of diverse pharmaceutical expertise, spearheading cross-functional projects across esteemed organizations, including Pfizer, Teva, and Ranbaxy. Adept at managing technology transfers for sterile injectable and driving product launches in regulated markets like the US, Europe, and Japan, ensuring compliance with USFDA, MHRA, and PMDA standards.Demonstrated excellence in end-to-end management of complex technology transfer programs, leading the successful commercialization of 5 oncolytic molecules across 55 markets with 135 regulatory submissions, achieving $5M+ cost savings through e;ciency and operational excellence initiatives.Extensive experience in managing GMP-compliant API Pilot Plants and delivering lifecycle programs, including new manufacturing line launches, R&D molecule commercialization, and due diligence of alternate suppliers. Expertise spans process validation, analytical thinking, and Six Sigma methodologies.Proven ability to lead and in>uence cross-cultural, remote teams in a matrix organization, optimizing global operations. Successfully centralized stability transfer programs, implemented cost-saving measures, and streamlined manufacturing processes for scalability and regulatory compliance.