Area of Expertise:
Jeff Pudlo, PhD
Jeff is a seasoned chemistry, manufacturing and controls (CMC) expert who provides developmental, operational, regulatory, quality, project management and business support to the healthcare products industry worldwide. He specializes in the areas of API and drug product development, technical transfer, method and process development and validation, container closure development and stability programming, supply chain establishment, CMC regulatory submissions, GXP compliance, quality management systems, and diligence/quality audits and operations/project management. His experience includes pharmaceuticals, biologics, and medical devices. Jeff has been involved in all stages of development and has provided both strategic and technical guidance. He has direct experience in the following: CMC program design, budgeting, and management; the provision of both technical and strategic support; CMO/vendor identification, contracting, and oversight; the design of scaleable and cost effect API manufacturing; formulation development; the establishment of compliant materials controls and specifications; written CMC/Quality sections of INDs, IMPDs, DMFs, and MAAs; interacted with cross-functional teams to ensure efficient development plans & execution; design of quality systems; compliance auditing and remediation; market and licensing due diligence reviews; and scientific/regulatory issue research and analysis. Jeff has a Ph.D. in Organic Chemistry from the University of Michigan.