• Lead cross-functional teams to develop and manufacture viral (AAV) and non-viral (LNP) gene-therapy drug candidates for Muscular Dystrophy and Haemophilia A Indications• Established and managed B2B relationships with contract development & manufacturing organizations (CDMOs). Responsible for overseeing the CDMO Strategy and Deliverables• Deployed strategies for the commercial launch of clinical assets accounting for Gross Margin, NPV, Market Competition, Manufacturing Capacity, and Technical feasibility

• Led the CMC team to successfully manufacture, release, and submit IND application for AAV based gene therapy targeting Huntington’s Disease• Worked with the regulatory authorities to address FDA comments and successfully enabled the lifting of a clinical hold

• Led MS&T group to perform successful Process Performance Qualification (PPQ) campaign at commercial scale. Drove authoring of PPQ protocols, reports, and campaign summaries. Authored and supported the successful submission of BLA for commercial production • Designed and implemented 2 major Operation Improvements resulting in decreased operating costs and improved productivity with a net effect of > $2 million in cost avoidance and hard savings year over year• Participated in audit activities from various Health Authorities (FDA, EMA, Japan PDMA) and responded to questions related to Process Robustness and Quality Control

• Pioneered the design and implementation of continuous manufacturing in Bristol-Myers Squibb leading to improved productivity and reduced downstream operating costs• Led cross-functional teams (Upstream, Downstream, Analytical and Drug Product) of 14 people to conduct late-stage process development, process characterization and process performance qualification (PPQ) at commercial-scale facilities. Authored BLAs and IND amendments• Led tech transfer to internal & external clinical manufacturing facilities enabling the production of clinical trial material for human use

• Lead downstream group in developing scalable purification processes (Chromatography & Filtration) for early and late-stage biologics• Implemented Design of Experiments (DOE), Failure Mode and Effects Analysis (FMEA), Process Characterization (PC) and data analysis using statistical concepts (SAS-JMP Software)• Authored IND amendments and responded to health authority questions

• Designed and executed experiments both at Column scale and Robotic High Throughput scale (Tecan) to support upstream and downstream process development activities• Authored Process Development reports and contributed to Facility Fit reports and manufacturing batch records

• Revealed the structural dynamics of natural iron sensor and regulator in human body; FBXL5 hemerythrin. This discovery directly enabled the research in understanding the mechanisms to address Anemia and Sickle Cell Disease• Served as Chairperson for the UT Southwestern Post-Doctoral Association overseeing activities including training, organizing symposiums, budget and setting regulatory guidelines