Susan is coming up to her 3rd year with XL-Lead. She is a proven leader in product development, project management, and operations in the medical device and pharmaceutical industry. She has over 30 years of experience in management of new product development programs from concept through commercialization. She has expertise in cutting edge manufacturing operations that increase product quality as well as manufacturing throughout, in the areas of generic drug product, packaging systems, sterilization, printing, serialization, secondary packaging, and regulatory submission.
She has a strong background in the following areas: Plastic resin selection, resin handling, injection molding, film extrusion, blow molding. Drug and device development, primary packaging development for injectable drugs, equipment selection and design for manufacturability, manufacturing process flow, as well as process development on a global platform. She is also an expertise in technology transfer, CMO management, regulatory requirement, and FDA submission. She has proficient knowledge of intellectual property management as well. Susan has supported the following projects in the last 3 years she has been with XL-Lead; Technology Transfer, Product Development, External Manufacturing Portfolio and Technical Management and China GMP and PTR Remediation Program and technical management.