Mark McElligott is a seasoned professional with over 20 years of diversified experience in Process Engineering, currently serving as the Owner and Principal Process Engineer at bioX LLC. His extensive expertise encompasses the development, design, and deployment of Single-Use Systems, making him a subject matter...
Mark McElligott is a seasoned professional with over 20 years of diversified experience in Process Engineering, currently serving as the Owner and Principal Process Engineer at bioX LLC. His extensive expertise encompasses the development, design, and deployment of Single-Use Systems, making him a subject matter expert (SME) in this rapidly evolving field. At bioX LLC, Mark leads a variety of key projects that focus on the process engineering life cycle for monoclonal antibodies (mAb), engineered recombinant therapeutics (ERT), gene cell therapies (GCT), hemoglobin-based oxygen carriers (HBOC), vaccines, and metered-dose inhalers/dry powder inhalers (MDI/DPI).
Mark's proficiency in process development and R&D laboratory operations is complemented by his hands-on experience in process design, product development, and comparability testing. He is adept at designing process equipment and instrumentation, ensuring that all systems meet stringent regulatory requirements, including Good Manufacturing Practices (GMP) and compliance with 21 CFR Part 11. His skill set also includes process simulation, technology transfer, and the development of Standard Operating Procedures (SOPs), which are critical for maintaining quality and consistency in biopharmaceutical production.
In his role, Mark is committed to delivering innovative solutions that enhance operational efficiency and product quality. His approach to consulting integrates a thorough understanding of Corrective and Preventive Action (CAPA) methodologies, ensuring that potential issues are proactively addressed. With a strong focus on biological, materials, chemical, and functional applications testing, Mark is dedicated to advancing the capabilities of bioX LLC and supporting the biopharmaceutical industry in achieving its goals.
