Integrated Supply Chains is a niche consulting services company operating in the pharma and medical device industry. As our website indicates our key advantage is that all our Principal consultants are ex-pharma personnel who have held senior positions within the industry. This experience means that we are intimately aware of the issues and challenges that face organisations and managers in the industry both from a business and compliance perspective. We mainly operate in the Manufacturing, Supply and Quality operations areas providing continuous improvement, cost reduction, performance improvements and organisation restructuring to our clients. Our approach to assignments tends to be a hands on partnership where we will work with client personnel to deliver improvements and the objectives of the assignment. Specialist skills contained within the group include automation, business system implementation, process and computer validation, vendor auditing and Lean Operations.

Led the implementation of an Electronic Batch Record (EBR) system for a new autologous cell therapy product for the manufacturing facility in the Netherlands. The project, which successfully met a challenging 7-month deadline, involved: Project Leadership: Oversaw all phases from planning and design to system qualification and post-go-live support. Implementation & Go-Live: Managed the successful deployment of the EBR system, ensuring a smooth transition to the live production environment. Post-Implementation Support: Provided ongoing support, including managing three live cycle system upgrades within the first six months, ensuring continuous operational efficiency and system optimization. Expansion & Planning: Initiated and planned the project to expand the EBR system to support the site's second product line.

Successfully recovered and led a high-stakes Electronic Batch Record (EBR) system implementation for an autologous cell therapy product manufacturing process in the US. This project was critical for meeting FDA requirements and improving the patient-to-patient turnaround time. Key responsibilities and achievements included: Project Recovery & Strategy: Revitalized an overdue project by changing the system to an enterprise corporate standard and restructuring the effort into two separate projects: one to upgrade the existing legacy system and another for the new system implementation. Accelerating Patient Timelines: A key objective of this project was to leverage the new system's automation capabilities to reduce manual and double verifications. This effort successfully shortened the patient-to-patient turnaround time, bringing the organization into alignment with critical FDA standards. Implementation Leadership: Managed the full project lifecycle for the new system, from initial planning and design to system qualification, training, and go-live.

Seasoned global executive specializing in Operations, Supply Chain, and Project Management for Pharmaceutical, Biotechnology & Cell Therapy. I help clients solve challenges, control costs, and deliver tangible value

Led a rapid organizational and operational shift, delivering a 40% boost in capacity and fundamentally improving quality standards. This required overhauling the organization—from restructuring the team and defining new workflows to driving the full recruitment cycle. Crucially, I led the operational build-out, installing a new production line, while strategically analyzing quality failures and initiating a strategic supplier improvement program to ensure sustainable, high-quality output

My assignment involved conducting the critical pre-acquisition technical due diligence for a product family of sterile products. These were a combination of both terminally sterilized and aseptically filled products. The primary objective was to identify and quantity and risks in proceeding with the acquisition as the products were out of stock in all markets at the time. This was due to the filed CMO ceasing operations prior to the completion of the transfer of the product manufacturing to a new CMO This assessment was essential for establishing the baseline operational risk and defining the scope of work required to successfully complete the subsequent tech transfer, scale-up, and commercial launch.

The assignment involved comprehensive program management to recover a high-risk Cell Therapy (CT) facility expansion. The project, converting the site from one large DS/DP suite for a cancelled product to five new Grade B suites, was stalled in design, jeopardizing critical timelines for customers. I immediately assumed control to finalize the design and cost models, which unlocked the subsequent streams: initiating the recruitment and organizational plan, executing the complex facility qualification, and integrating the final product technology transfer to meet commercial and clinical deadlines.

My assignment was to conduct a comprehensive design review of the existing Cell Therapy (CT) Clinical Facility to assess its suitability for U.S. regulatory requirements. This review was a critical pre-cursor to any FDA submission, focusing on verifying that the current facility design, layout, and utility systems met the stringent FDA GMP standards necessary to support the supply of Phase 3 clinical product to the United States

As a direct follow-on from the foundational Cell Therapy Facility construction program, I executed a crucial engineering feasibility study designated as Phase 2 Commercial Expansion. This study was the strategic blueprint for the next generation of growth, focused on analyzing and determining the optimal path for rapidly expanding the existing Viral Cell Therapeutic Commercial Facility on the Texas campus. This ensured all future expansion plans were technically sound, economically justified, and aligned with long-term commercial demand.

My assignment was to direct the complete program for a greenfield expansion in Texas, overseeing the design, construction, and qualification of both a new Clinical and Commercial Viral Cell Therapeutic Facility. I was responsible for integrating the workstreams of all internal and external partners to ensure the seamless progression of the project. A key deliverable was ensuring the facilities were fully compliant with EMA and FDA requirements for global supply, specifically engineered around single-use disposable systems for next-generation viral therapeutic manufacturing

Manage critical improvement projects on client site to ramp up capacity and improve costs. Projects include • Machine shop expansion and equipment installation. This project also included re-designing the material flows • Re-layout of Warehouse to improvement service and inventory accuracy through assessment of inventory management system and re-design of inventory processes. This included updating of procedures and retraining operators • Management of the sites regulatory testing programme to obtain EU approval for 4 new products

In my role as a Technology Consultant on Facility Due Diligence, I focused on evaluating operational factories within Europe for a Private Equity Client. My responsibilities included assessing their current conditions and identifying risks and opportunities. This analysis was crucial for informing acquisition assessments and ensuring informed investment decisions.

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