Craig Mathews
About Craig Mathews
Craig Mathews is a Manufacturing Specialist at Andelyn Biosciences, where he focuses on the production of gene-based therapeutics. He has a background in bioengineering and biomedical engineering, with experience in cGMP clean room practices and FDA regulation compliance.
Work at Andelyn Biosciences
Craig Mathews has been employed at Andelyn Biosciences as a Manufacturing Specialist since 2021. In this role, he focuses on the production of gene-based therapeutics for clinical phase trials. His responsibilities include ensuring compliance with current Good Manufacturing Practices (cGMP) and maintaining quality assurance and quality control standards in an aseptic environment. He operates within the RB3 facility of Nationwide Children’s Hospital Research Institute, contributing to the advancement of innovative therapies.
Education and Expertise
Craig Mathews holds a Bachelor of Applied Science in Bioengineering and Biomedical Engineering from Miami University, which he completed from 2013 to 2017. Additionally, he studied Full-Stack Network Engineering at NexGenT from 2019 to 2020. His educational background provides a solid foundation in both engineering principles and technical skills relevant to the biomedical field.
Background in Biomedical Engineering
Before joining Andelyn Biosciences, Craig Mathews worked as a Biomedical Engineering Technician I at OhioHealth's Grant Medical Center from 2019 to 2021. Prior to that, he served as a Research Assistant at The Ohio State University Wexner Medical Center for eight months in 2018. These roles allowed him to develop practical skills in biomedical engineering and gain experience in healthcare settings.
cGMP and Regulatory Compliance Skills
Craig Mathews possesses thorough experience in cGMP clean room policies and procedures. He is proficient in recording and reviewing technical government documentation in compliance with CFR Title 21 guidelines established by the FDA. His expertise ensures that manufacturing processes adhere to industry standards, which is critical in the production of therapeutics.
Technical Proficiencies
In addition to his regulatory knowledge, Craig Mathews is skilled in using OpenFoam CFD Analysis software for computational fluid dynamics applications. This technical proficiency enhances his ability to contribute to projects requiring advanced modeling and simulation techniques in the biomedical engineering field.