Mark Rogers brings over 30 years of quality and regulatory leadership in the cell, gene, and regenerative medicine space to his role as VP of Quality and Regulatory Affairs at Merakris. Most recently, Mr. Rogers served as Chief Quality and Regulatory Officer at Surgenex, and a Senior Director of Quality Technical Services for a cell and gene therapy company where he led the validation of QC analytical methods, facility expansions, and process validations to support a Biologics License Application (BLA) for synovial sarcoma.
Mr. Rogers spent eight years as Vice President of Quality Assurance and Regulatory Affairs at MiMedx. He provided critical quality and compliance oversight during a period of tremendous growth, with the company’s regenerative tissue products expanding from $40 million to over $400 million in annual sales. Mr. Rogers also led MiMedx’s IND submissions to initiate Phase II and III trials across multiple indications including plantar fasciitis, knee osteoarthritis, and Achilles tendinosis.
Leveraging over two decades of experience spanning vaccines, monoclonal antibodies, small molecule pharmaceuticals and regenerative medicines, Mr. Rogers is exceptionally qualified to lead Merakris’ quality and regulatory operations. This includes providing expert guidance on IND-enabling activities, clinical trial governance, and preparing future BLAs as Merakris advances its pipeline of novel therapeutics for wound healing.
Mr. Rogers holds an MBA from UNC Chapel Hill and a BS in Chemistry from North Carolina State University. His deep technical knowledge paired with quality excellence makes him an outstanding fit to steer Merakris’ growth while ensuring patient safety remains paramount.