(Westbury, NY – March 16, 2021) Fran Zipp, President and CEO of Lachman Consultants, Inc., a leading provider of compliance, regulatory affairs, and technical services to global life sciences organizations, today announced that John McShane has joined the firm as Vice President of Cell & Gene Therapy, Compliance and Business Development. In this role, McShane will lead the Cell & Gene Therapy division within Lachman’s Compliance Practice Group, providing leadership and insight on regulatory, compliance and enforcement standards to this mission-critical field.
McShane is an accomplished industry expert with extensive leadership, business development and project delivery background in quality, manufacturing, research and development, and engineering. His distinguished career spans traditional pharmaceutical modalities and various ATMPs with a particular focus on cell and gene therapies.
“With more than 35 years of broad industry experience, John is well-qualified to take on this multi-faceted role,” noted Zipp. “His impressive track record in navigating complicated compliance issues, combined with his strong leadership and entrepreneurial spirit will be of great value to our team – and our international clientele.”
Prior to joining Lachman Consultants, McShane was Managing Partner at Validant Consulting, where he built a successful biopharmaceutical consulting business specializing in Quality Systems, technical transfer, pre-approval inspection readiness, and gene and cell therapy quality. In addition, McShane held several Director roles at Genentech/Roche, most recently as Director, External Quality Biotech Drug Substances and Director, Global Quality System and Support. His career began at Abbott Laboratories’ Global Pharmaceutical Operations, where he took on increasingly complex roles over 27 years in Manufacturing, Research & Development, Project Management, Quality and Pharmaceutical Operations. McShane earned his M.B.A. from the University of Chicago and his B.S. in Chemical Engineering from Purdue University.
“I am excited to join the Lachman Consultants team in supporting our biopharmaceutical clients in the cell and gene therapy industry,” commented McShane. “They are developing life-saving therapies for patients around the world, and we will continue providing valuable insight and services that advance these critical efforts.”