John McShane, M.B.A.
John McShane, M.B.A., Vice President, Cell & Gene Therapy, Compliance and Business Development at Lachman Consultants, oversees and manages the Cell & Gene Therapy division within the Compliance Practice Group. An accomplished professional, Mr. McShane has extensive industry experience in international biopharmaceuticals, cell and gene therapy, and biotechnology. His distinguished career spans traditional pharmaceutical modalities and various ATMPs with a particular focus on cell and gene therapies. Mr. McShane delivers high-level biotechnology, biopharmaceutical, and cell and gene therapy project oversight/management, workflow planning, and analysis to Lachman clients. He is proficient in scale-up activities, manufacturing, distribution, and pre-approval inspection readiness/licensure. He is also an expert in Quality System build, technical transfer, engineering, and research and development. Knowledgeable of FDA regulations and industry best practices, Mr. McShane guides Lachman clients in project assessment, providing recommendations based on regulatory requirements and compliance processes.