Samantha Burton

Samantha joined BioTechLogic in 2022 with over nine years of intensive experience in the startup biotechnology space. As part of the BioTechLogic team, Samantha provides consulting services in aseptic and cGMP process optimization, process and facility remediation, facility design and management, and preparation of CMC regulatory submissions. Her role includes preparing and reviewing qualifications, validations, risk assessments, gap assessments, batch records, and other technical documents. She also supports project management associated with contract manufacturing, process scale-up, technology transfer, commercialization, and regulatory submissions. During her time at BioTechLogic, Samantha has had the pleasure of working with a wide range of clients of varying sizes and with products at all design stages and process scales. She has supported clients in multiple sectors, including cell and gene therapy, oligonucleotide and peptide therapeutics, recombinant proteins, and vaccines. While Samantha appreciates helping all clients however possible, the projects she cherishes the most are the extensive remediation projects and the projects that grow and evolve with the client’s needs; as these longer projects require in-depth integration with the client and their team.

Previously, Samantha was a Senior Engineer / Program Manager at COUR Pharmaceuticals, where she was responsible for process design and management of new and existing drug product manufacturing. During her tenure at COUR, she coordinated translational activities of five immune-modulating nanoparticle therapies from R&D to GMP production and was the project lead for designing a large-scale pilot manufacturing facility. Prior to COUR, Samantha was a Product Development Engineer at a biotechnology company in Massachusetts, which develops innovative solutions for cell culture, tissue repair/regeneration, and offers biologic contract research and manufacturing services. In Massachusetts, Samantha led all cleanroom operations and process development efforts for emerging therapies and commercial products. She has an in-depth understanding of cleanroom design, design control, process validation, and Good Manufacturing Practices. Samantha received her B.S. in Chemical Engineering with a Biomolecular Concentration from the University of Notre Dame.

• Facility and Equipment Controls Gap Analysis for cGMP clinical manufacturing and commercial readiness.
• Draft and author CMC regulatory dossiers, including CTD (Module 3 and Module 2 QOS) for INDs and BLAs, Briefing Books, and IMPDs.
• Prepare detailed project plans and schedules in support of projects being managed. Assemble and lead project kick-off meetings. Provide timely communication of project progress and coordinate project meetings, as well as any necessary review cycles.

COUR Pharmaceuticals Development Company, Inc.
Program Manager / Senior Engineer

Arteriocyte, Inc. DBA Compass Biomedical
Product Development Engineer

Isto Biologics
Project Manager

University of Notre Dame
B.S. in Chemical Engineering, Biomolecular Concentration