Patrick Haley

Background

About Patrick Haley

15 years industrial experience in biopharmaceuticals, drug development, and project management. • 10 years of experience managing professionals in the lab or managing outsourcing relationships, projects, and functional teams. • 10 years of experience with technology transfer problems and resolutions at both research/GLP and cGMP contract manufacturing organizations. • 9 years of experience with cGMP phase I, II, and clinical production and CMC sections for IND submissions. • 8 years of experience with biologics project management and client and CMO relationship management. • 8 years of experience with lean six sigma, 5S, and continuous improvement methodologies. • Experience with upstream and downstream manufacturing equipment from shake flask through 3500L fermenters/bioreactors and associated downstream processing equipment. • Experience with statistical design of experiments (DOE) generation, implementation, and analysis. CAREER SUMMARY DIRECTOR, PROJECT MANAGEMENT, qualified to lead direct reports and team members to execute large projects to support corporate needs, client needs, CMC timelines, and budgets. Proven skills developing cross- functional team relationships, facilitating project meetings, and aligning teams on integrated decisions. Experience in client based project management and CMO selection, contract initiation and detailed scope build out, relationship management, team formation and leadership, and project monitoring. Qualified in research, development, and production scale manufacturing processes necessary for successful recovery of live bacterial cell and enzymatic products. Proficient in applying standard and novel manufacturing methods to the development and technology transfer of biotherapeutic and enzymatic products. Recognized by management for exceptional communication skills, laboratory product development, and scientific input to cGMP production.