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Varadharaj VIJAYAKUMAR

Associate Director

Company
WUXI BIOLOGICS
Position
Associate Director
Biography
Varadharaj Vijayakumar is an Associate Director (Aseptic Processing) at Wuxi Biologics, bringing over 16 years of experience in the Pharma/BioPharma industry. Specializing in pharmaceutical technical operations, his expertise encompasses aseptic processing, sterility assurance, manufacturing technology, process validation, failure investigations, troubleshooting, continuous improvement, and Lyophilization Technology. He is also highly skilled in Isolators with VHP cycle developments and resolving complex technical, regulatory, and GMP issues. Throughout his career, Varadharaj has successfully managed GMP inspections and audits, addressing inspectional observations from leading regulatory bodies such as WHO, USFDA, UK-MHRA, ANVISA, INVIMA, and CDSCO. His broad experience includes working with well-established pharmaceutical and biologics manufacturers, including Franz Ziel GmbH Germany, Pfizer India, Dr. Reddy's Laboratories Ltd, Emcure Pharmaceuticals (Oncology Division), and Biocon Biologics (India) Ltd. Varadharaj has played an integral role in numerous projects, from concept design (greenfield and brownfield) to the successful commercialization of products and their continuous improvement. He has led teams in tackling operational and regulatory challenges, including regulatory reviews, production output, validation constraints, and addressing inspectional observations. A registered pharmacist with a postgraduate degree in Pharmaceutical Sciences, Varadharaj is an active member of professional organizations such as ISPE, PDA, GENAP Summit, Pharma Days, Innovotrix, TBM, Speak Pharma, R&Y, Conferenzia, and Lyophilization World. In addition to his industry work, Varadharaj contributes to the field by publishing technical articles, teaching students, and delivering webinars and training sessions on topics like qualification and validation for aseptic processing. His international experience, which spans countries such as Russia, the UK, the USA, Ireland, India, and Germany, has allowed him to train operational personnel through both short-term assignments and long-term global engagements.

Speaker on

Impact of the New EU Annex 1 on Lyophilization in the Pharmaceutical Industry

Educational How to manage the revision of cGMPs Annex 01 for sterile products
06/04/2025 | 13:20 - 13:35 | TPD Room

How to manage the revision of cGMPs Annex 01 for sterile products

Panel Discussion How to manage the revision of cGMPs Annex 01 for sterile products
06/04/2025 | 14:15 - 14:30 | TPD Room