Bawan Elayathamby Email & Phone Number

United States

Amsterdam, 1105BP, NL

Led supply chain operations with a focus on the planning, sourcing, purchasing, and timely delivery of raw materials for clinical and commercial batches. In addition to managing the procurement team, collaborated cross-functionally to achieve operational goals and provided oversight to warehouse operations when required, and successfully implemented cost.

Amsterdam, 1105BP, NL

Led the AAV5-based GMP manufacturing operations for gene therapy from early-stage clinical batches to commercial production. In 2022, as Interim Head of Manufacturing, successfully guided the team through a Pre-Approval Inspection (PAI) for HEMGENIX, resulting in FDA, EMA, MFDS, HLfGP, and Health Canada approvals for the first AAV5-based gene therapy for.

Amsterdam, 1105BP, NL

Led the Lexington site during the challenging period of the COVID-19 pandemic, navigating global supply chain disruptions and staffing shortages. Successfully managed these challenges, ensuring material availability and completing the process validation (PV) campaign for HEMGENIX. Collaborated cross-functionally to meet critical timelines for both clinical.

Amsterdam, 1105BP, NL

Oversaw a team of 12 direct reports, managing and providing hands-on support for clinical batches for various programs, including buffer preparation, autoclave operation, media fill qualification, and Cell and virus bank processes, while conducting real-time batch record reviews. Collaborated closely with quality control to plan testing, manage EM.

Amsterdam, 1105BP, NL

Utilized extensive experience in insect cell cultivation and AAV production and supported clean room daily operations for both upstream and downstream processes, Including production of cell/virus bank drug product fill and visual inspection operation. Collaborated with QA for batch record reviews, deviation investigations, and validation protocol.

Amsterdam, 1105BP, NL

As the process owner for research and development batches, supported the production of AAV-based drug substance and drug product batches for early-stage programs, including manual drug product fills under BSCs in R&D labs. I also supported the Process Development (PD) team by facilitating upstream, downstream, and buffer preparation activities, ensuring.

Paris, France, FR

Managed the upstream process, expanding CHO cell lines from cryo vial thaw to 200L and scaling up to a 2000L bioreactor for the production of Fabrazyme and Cerezyme, ensuring the availability of enzyme replacement therapy for Fabry and Gaucher patients. Performed CIP and SIP procedures to sterilize 200L and 2000L bioreactors, as well as 5000L media and.

Paris, France, FR

Tokyo, JP, JP

Supported downstream UF/DF and column chromatography operations, including column packing for Replagal and the upstream roller bottle process for Elaprase, ensuring the availability of enzyme replacement therapies for patients with Fabry disease and Hunter syndrome.

Tokyo, JP, JP

Charlotte, NC, US

Managed workflow to ensure all service level agreements were met while coaching and developing 10 associates using “The What and The How” tactics to enhance performance, increase production, and minimize waste. Led associates through ISO 9001:2000 certification and sustainable 5S implementation, providing one-on-one training for machine operator.

Charlotte, NC, US

Master Of Science - Ms, Regulatory Affairs

Bachelor Of Science - Bs, Biotechnology

Associate Of Science - As, Biotechnology