PhD level biomedical scientist with over 15 years of experience in drug development, gene therapy, and ophthalmology, I am a highly accomplished biomedical professional. My career has been marked by leadership, scientific expertise, regulatory intelligence, and cross-functional collaboration skills. I have led the end-to-end drug development of multiple products from initial research and development to clinical trials and have excelled in managing drug product life cycles. My passion is to advance healthcare and deliver innovative therapies to patients suffering from debilitating diseases.Manufacturing Expertise:• Developed manufacturing process for three AAV-based gene therapies and one fusion protein.• Drove manufacturing process development for gene therapies across GLP, phase 1/2, and phase 3 stages.• Spearheaded the development and validation of analytical methods for in-process samples, drug substance (DS), and drug product (DP) release, along with stability-indicating methods for AAV-GTs, monoclonal antibodies, and fusion proteins.• Led the development and execution of phase 3, process characterization, and PPQ (Process Performance Qualification) strategy for BLA submission.• Formulated process characterization strategies for DS and DP fill-finish.• Conducted stability studies for DS and DP, adhering to ICH guidelines.• Designed and executed real-time, freeze-thaw, accelerated temperature, and shipping validation studies.• Designed and implemented in-use stability and device compatibility studies for clinical formulations.Pharmacology and Toxicology studies:• Designed and guided nonclinical studies in mice, nonhuman primates, minipigs for multiple ocular disease programs.• Collaborated with academic groups and CROs for IND-enabling pharmacology, safety and biodistribution studies.• Development and validation of Bioanalytical methods (ADA, qPCR ELISA, ELISpot) across different tissue matrices.Regulatory work:• Devised effective regulatory strategies and led the preparation of over 15 regulatory submissions for diverse ocular programs, including responses to information requests, resulting in a 100% success rate.• Successfully led four IND submissions and secured approvals.• Submitted six Orphan Drug Designations to the US FDA and three to the EMA for ocular products, defending and winning approval through written and oral presentations.• Prepared multiple briefing packages for End of Phase 2 and pre-BLA meetings with the US FDA, resulting in approvals.