Christina Malin

Senior Consultant

Christina specializes in CMC management, CMC regulatory submissions, GXP compliance, quality systems, and operation/project management. Her experience includes pharmaceuticals, biologics, nutraceuticals, ophthalmics, tissue engineering, and medical devices. She has over 20 years of experience in hands-on CMC development, scale-up, technology transfer, qualification and optimization of cGMP manufacturing and oversight. Christina has performed, developed, and optimized cGMP-compliant manufacturing and formulation of small molecules and biologics. She has hands-on experience in the design, qualification, and approval of international multiproduct contract manufacturing sites, including cell banking, fermentation, purification, and aseptic filling suites. She has managed development, clinical, commercial supply, and site-to-site technical transfer projects. Christina has participated in and managed the creation and implementation of quality management systems for pharmaceutical, biologics, packaging, and shipping operations including original creation, as well as merging and upgrading existing systems. She routinely authors and manages the compilation and submission of CMC and quality sections of regulatory filings. Christina has a B.S. in Chemical Engineering with a Minor in BioEngineering from the University of Pittsburgh.