Diluks De Silva
Executive Consultant
Diluks De Silva is a seasoned industry professional with over 20 years of expertise in Cell and Gene Therapy (CGT), Radiopharmaceutical Therapy, Theranostics, Biopharmaceuticals, Commercial Operations, and Quality. He is a seasoned executive in driving innovation and strategic leadership. Formerly the Head of North American Country Quality at Novartis, Advanced Accelerator Applications (AAA), Diluks oversaw quality operations for AAA site operations, Radio Pharmacy operations, and supply chain operations in North America. He played a crucial role as a member of the country’s commercial executive leadership team and a member of the global quality leadership team at AAA.
Diluks led the first commercial CART-T (KYMRIAHTM) Quality Manufacturing organization, successfully expanding its reach across the US, EU, and APAC regions. His pioneering efforts and ability to foster cross-functional collaboration contributed to influencing and redefining the regulatory landscape supporting Cell and Gene Therapy commercialization.
In his earlier role with Novartis, Diluks joined the BioProduction Operations Singapore team to build and commission a new 700 MUSD cell culture production site. Diluks Spent four years on the project, holding critical roles such as head of QC, director of quality, and head of strategic projects and operational readiness.
His extensive experience spans greenfield design, construction, commissioning, qualification/validation, product transfer, manufacturing, quality control, quality assurance, commercial GMP readiness, and product launches. Throughout his career, Diluks has demonstrated proficiency in handling FDA inspections (routine and PAI) for pharmaceuticals, biologics, and advanced therapeutic products. His leadership in lean manufacturing programs and sponsorship of Six Sigma initiatives in QC and QA at Novartis optimized quality and compliance, yielding significant business and patient benefits.
Diluks holds a B.S. in Biology from California State University, Sacramento, California.
