Ryan Downey

WORK HISTORY

EDUCATION

SKILLS

ABOUT RYAN DOWNEY

25+ years in Pharmaceutical Quality and Manufacturing environments. Experience leading a business and product commercialization efforts for proprietary and contract manufacturing organizations. From my Analytical, Quality Management and Operations background I am closely familiar with all aspects of staffing, managing and operating a GMP regulated manufacturing facility. Looking to network with others in similar or related fields in an effort to gain knowledge on industry trends and opportunities in support of executing the growth vision at August Bioservices.Accomplishments-Currently leading all technical evaluations of incoming project at August Bioservices and key opinion leadership for ongoing client projects-Supported teams managing CMC planning and execution for the FDA approval of novel drug products -Launched a cGMP 503B Outsourcing Facility business segment to complement other core business efforts-Experience in solving complex laboratory and manufacturing related problems in a team environment-Direct involvement with numerous regulatory audits by the FDA, EMEA, Spanish Health Authority, Irish Medicines Board and others with no major/critical observations-Supported implementation and upgrades of flagship laboratory systems such as Chromatography Data systems and Laboratory Information Management systems-Developed laboratory training programs-Supported on-time launch of pharmaceutical products both proprietary and generic.Specialties: Technical skills for management of manufacturing and laboratory systems. Spirit for team leadership and continuous improvement. Creative thinking for solving complex problems. Interdepartmental networking skills to facilitate organization wide accomplishments. Hands on experience implementing lean manufacturing concepts in a laboratory and production environment.