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 optimization strategies, resulting in $550K in annual savings through supplier segmentation and sourcing alternatives. By partnering closely with QA and QC, ensured the timely receipt and release of GMP and non-GMP materials, further enhancing commercial and clinical supply operations. Actively collaborated as a CMC team member for clinical programs, ensuring seamless interaction with CMOs, CMC teams, and external manufacturing to meet clinical timelines and ensure successful patient dosing by managing the shipment of clinical supplies and drug products to clinical sites. Coordinated just-in-time labeling, packaging, distribution, and expiry extensions to support clinical trial demands, which is key in driving efficient clinical trial timeline management. Also worked closely with external quality and clinical teams, reviewing and approving clinical trial protocols, pharmacy manuals, batch records, and label generation and approvals.

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 Hemophilia B. Worked closely with the Quality team, managing inspection readiness and internal audit logistics, while conducting site walkthroughs to assess facility, process, and product risks. Addressed identified issues, ensuring the facility, equipment, processes, and personnel were fully prepared for regulatory inspections. In response to increased production demand following the commercial license, innovative scheduling strategies were introduced that allowed for parallel production of clinical and commercial batches. This approach effectively met the demand while mitigating cross-contamination risks under strict cGMP compliance. Additionally, collaborated with site leadership to implement tier structures, actively participating in daily forums to track and analyze operational KPIs.

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 and commercial batches while maintaining a strong commitment to compliance by overseeing all QMS activities, including deviation investigations, CCRs, CAPA, and internal audits. Spearheaded commissioning, qualification, and validation (CQV) activities, ensuring the facility and equipment functioned as required and operators were trained and qualified. Promoted a safety-focused culture by conducting classroom training on cGMP, aseptic techniques, and cleanroom behavior. Additionally, partnered with HR to drive employee engagement initiatives, successfully recruiting and onboarding new talent while enhancing team performance through SMART goal-setting and individualized development plans.

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 excursions, and worked with quality assurance to ensure timely document reviews and maintain cGMP compliance. Participated in deviation investigations, partnering with cross-functional teams to identify root causes and implement corrective actions, driving continuous improvement and operational efficiency.

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 execution, including smoke studies for BSCs and RABS.

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 the timely completion of PD studies.

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 harvest tanks, successfully executing media and harvest transfers according to the MPS. Conducted aseptic sampling for cell counts and testing. Leveraged comprehensive knowledge of mammalian tissue culture in large-scale bioreactors to resolve equipment, process, and compliance issues while coordinating daily bioreactor suite activities and training new employees.

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 certifications. Maintained ISO 9001:2000 certification by updating and reviewing documents and conducting associate awareness training. Proven success in improving associate performance through behavioral coaching, positively impacting performance metrics. Additional responsibilities included workflow scheduling, customer service, problem resolution, and capacity planning.

Charlotte, Nc, Us

Master Of Science - Ms, Regulatory Affairs

Bachelor Of Science - Bs, Biotechnology

Associate Of Science - As, Biotechnology