Shannon Wadman – Owner and Principal Consultant
An accomplished professional successfully running my own consulting business since 2013. My business serves clients in the pharmaceutical, medical device, gene-editing biotechnology, and biomaterials manufacturing industries. I currently provide a variety of services, including business development for new products or new market positioning for existing portfolio products, regulatory support, technical writing, and project management services to clients of all sizes; from start-up to multi-national conglomerates. I have made this business a success based on my diverse experience, including:
- More than 10 years of project management and regulatory affairs experience related to products using gene-editing biotechnologies and/or complex biotherapeutics including cell-based and multi-specific antibodies. Experience includes support for USA and international regulatory submissions and product registrations
- More than 15 years of corporate cross-functional project management experience in pharmaceutical and medical device industries and a successful track record of leading and working within interdisciplinary teams to gain product market approval
- Seven years of experience leading projects and people within an ISO 13485 certified and 21 CFR 820 compliant Quality Management System, including leadership of manufacturing process and quality system improvement projects
- Experience in pharmaceutical translational R&D supporting medical, clinical, and scientific affairs including managing competitive intelligence at major medical conferences
- Experience managing large contract R&D programs related to antibody and small molecule drug delivery product development including manufacturing planning in an environment compliant with FDA Current Good Manufacturing Practices (21 CFR parts 210/211 and aseptic processing for sterile drug products)
- Advanced problem solving and analytical capabilities including well developed skills in statistical methods, technical writing, and presentation of complex topics across a broad spectrum of audiences
- Well established reputation for synthesizing complex technical and market information into cohesive focused messaging to motivate innovation and development that aligns clearly with high value customer needs and business objectives