Thushari Bombuwala
About Thushari Bombuwala
Thushari Bombuwala is the Associate Director and CMC Program Lead at Bristol Myers Squibb, with over 17 years of experience in the biologics pharmaceutical industry.
Company
Thushari Bombuwala is currently employed at Bristol Myers Squibb, serving as the Associate Director, CMC Program Lead. In this capacity, she plays a vital role in the oversight and coordination of various CMC (Chemistry, Manufacturing, and Control) programs within the organization.
Previous Employment at Celgene
Before joining Bristol Myers Squibb, Thushari Bombuwala was an Associate Director at Celgene, where she worked for 7 months in Summit, New Jersey, from 2019 to 2020. Her role there involved significant operational responsibilities within the CMC team.
Previous Employment at Pfizer Pharmaceuticals
Thushari Bombuwala has extensive experience at Pfizer Pharmaceuticals, where she held multiple positions over 15 years. She worked as a Principal Scientist from 2010 to 2019, a Sr. Research Scientist II from 2009 to 2010, and a Sr. Research Scientist from 2004 to 2009. Her long tenure at Pfizer is marked by expert-level contributions in research and development, particularly in the biologics pharmaceutical sector.
Education and Expertise
Thushari Bombuwala achieved a Ph.D. from the University of Peradeniya between 1995 and 2000, complementing her earlier B.Sc. from the same institution (1990-1994). She furthered her education at the Karolinska Institutet from 1995 to 1997. Her academic background has provided a strong foundation for her specialized work in vaccine and ADC conjugation chemistry, as well as analytical assay development for biomolecules.
Industry Experience
With over 17 years of experience in the biologics pharmaceutical industry, Thushari Bombuwala has specialized in vaccine and ADC conjugation chemistry and analytical assay development for carbohydrates and proteins. She has led projects, collaborated with bioprocess R&D sub-teams, and worked closely with manufacturing organizations for the technical transfer of processes.
Regulatory Documentation and Quality Assurance
Thushari Bombuwala has significant experience in authoring, reviewing, and data verifying regulatory documents. This includes Biologics License Application (BLA), Investigational New Drug (IND) Drug Substance (DS) sections, and Drug Master File (DMF). She has also reviewed project reports, tech transfer documents, batch records, laboratory qualification, and critical process qualification reports.