John Walker Email & Phone Number

Dublin, Ie

Dublin, Ie

Dublin, County Dublin, Ireland

Dublin City, County Dublin, Ireland

Development and implementation of a comprehensive small-scale model of a small-scale mammalian-cell (CHO) process, enabling optimization of key process parameters and driving a robust troubleshooting environment for large-scale deviations.Optimized aseptic cell culture procedures, maintaining 3L bioreactors to ensure comparability with large-scale processes. Applied expertise in BGA, metabolite analysis, cell counters, and osmometers to provide investigation support, allowing for reduction in timelines for deviations by approx. 20%. Identified the need for eLogbooks and integrated the system, resulting in a reduction in documentation errors and improved audit readiness reduction in work hours of approximately 5 hours per week for the team. Orchestrated the seamless adoption of the Second-Generation Process, resulting in providing troubleshooting support during large-scale tech transfer.Conducted Vmax Study to facilitate second sourcing of filters; authored protocols, executed testing, and compiled comprehensive reports. Spearheaded a rigorous study to evaluate the extension of raw material ambient storage time, utilizing a small-scale model; identified opportunities to extend ambient storage time by 48 hours, increasing warehouse operational efficiency. Created and implemented a comprehensive qualification protocol for the new working cell bank, conducting rigorous testing and analysis to confirm suitability for Keytruda small-scale runs, keeping timelines on track. Continuous Improvement Champion for MS&T Department, tracking and implemented improvements.

County Dublin, Ireland

Developed and executed a comprehensive tech transfer plan for a groundbreaking Stem Cell Manufacturing process, resulting in the successful implementation of the process type in Ireland for the first time. Led and facilitated tech transfer activities, including training, documentation creation, and execution of engineering and process validation runs, achieving seamless integration of new technologies, achieving timelines. Implemented a systematic approach to support micro, QC, QA, and validation teams in the manufacturing process; developed and maintained MES BMRs, resulting in fewer errors and quicker review process, 20-man hours per batch. Arranged and delivered interactive workshops on aseptic technique, enhancing team's skills and knowledge while reducing errors, ensuring adherence to timelines. Spearheaded the creation of a comprehensive Contamination Control Strategy, leveraging industry best practices, contributing to a successful first time GMP audit. Served as the subject matter expert for Alofisel Manufacturing, providing guidance and expertise on drug substance and drug product processes, ensuring compliance with regulatory standards and driving successful audits. Led the development and execution of a Process Simulation Strategy, encompassing risk assessments, SOPs, and BMRs, ensuring that product manufacturing was in control, meeting patient needs for product. Led the end-to-end process of raising and completing change controls and deviations, leading to timely closure of records and reducing repeat deviations.

County Galway, Ireland

The primary objective of this course is to provide formal training in cellular bioprocessing for clinical application for those who wish to study key emerging technologies for medical intervention. The course is designed according to Good Manufacturing Practices and provides a rigorous scientific underpinning for the development of a cellular therapy.

County Galway, Ireland

Work Experience in the Galway Blood and Tissue Establishment. Focusing on Environmental monitoring, material transfer, documentation and cryopreservation.

County Waterford, Ireland

Worked as a bartender, often leading functions such as outdoor marquee wedding receptions.

Master Of Science - Ms, Cellular Manufacturing And Therapy, First Class Honours

My master's degree in Cellular Manufacturing and Therapy is multifaceted, from current cutting-edge research of potential therapies.

Bachelor Of Science - Bs, Biological And Biomedical Sciences, 2Nd Class Honours