Mike Morelli

Background

About Mike Morelli

VICE PRESIDENT OF QUALITY WITH 20+ YEARS OF EXPERIENCE • Responsible for Quality Assurance, Quality Control, Product Development, Validation and Regulatory Affairs at five concurrent operating sites. • Evaluated acquisitions of operating divisions, planned and implemented necessary corrective actions, and achieved corporate annual revenues >$100 million. • Performed scientific, technical, and regulatory examination and evaluations to enable companies to enter, and exit new businesses and product classifications. • Lead company representative for numerous FDA inspections and Quality Audits. Responsive key member of FDA inspection and ISO certification teams. Experience in rehabilitation of non-compliant companies and facilities. • Commercialized ~500 products with partners from major pharmaceutical and consumer packaged goods companies. Developed and commercialized chewable supplement products with annual revenues >$25 million, with sales to J&J, Costco, and major retailers. • Established a new pharmaceutical manufacturing company based around BFS Technology: o Planned and implemented a $100 million dollar facility build-out. o Established the framework and core structure of the operating company. o Developed business strategies. • Lead and directed company activities with a thorough understanding of Quality Systems, Regulations, ICH Guidelines, manufacturing principles, chemistry, biochemistry, biology and microbiology. • Extensive management and supervisory experience, leading organizations in a broad range of healthcare manufacturing industries. • Interacted at the highest levels with representatives from government agencies, certifying bodies, corporate management, and critical customers. • Ability to work independently as well as in teams, with excellent supervising skills. • Excellent verbal and writing communication skills. • Developed corporate compliance and development strategies, formulated and implemented regulatory responses and agency submissions. • Strongly self-motivated to establish Validation practices immediately after FDA rule. Developed and implemented Validation programs at many drug/device sites. • Coordinated all aspects of R&D from competitive product analysis and formulation through prototype development/screening, proof of concept, method and process development, technology transfer, and validation. • Authored submissions to regulatory agencies including CMC sections for applications. • Hands-on knowledge of manufacturing sterile and non-sterile drugs, medical devices, dietary supplements, medical foods, and cosmetics.