Samuel May

Samuel May has extensive experience in the field of quality assurance and regulatory compliance. Samuel currently works as a Principal Technical/Business Consultant at Soft Planet Synergy, LLC, where they are responsible for implementing QMS, regulatory strategy, and filing services. Samuel also facilitates GMP/GCP audits and provides regulatory and contract services. Additionally, Samuel recruits technical staff and recommends them for employment based on client needs.

Prior to their current role, Samuel worked as a Principal Quality Assurance Engineer at AGC Biologics. In this position, they led the development and scale-up of biologics manufacturing for quality compliance and customer satisfaction. Samuel also recruited and mentored staff and implemented principles of quality engineering. Samuel was involved in strategy and integration of capital projects, as well as support for acquisition and staffing of retrofitted/scaled facilities.

Before joining AGC Biologics, Samuel served as the Executive Director for Quality/Regulatory/Compliance at InvisiDerm Healthcare. Samuel was responsible for overseeing quality, regulatory, and compliance activities in the organization.

Samuel also held positions at Hitachi America- Pharmaceutical Division as an Associate Director, Nektar Therapeutics as a Senior Validation Specialist, Amgen as the Colorado Site Manager (Corp & Site Quality), PharmComm/Cetan Technologies as the West Coast Operations Director, Theratech/Watson Pharmaceuticals as a Regulatory Research Scientist, and Mountain States Analytical (Division of Lancaster Laboratories) as an Associate Chemist/Client Services.

Throughout their career, Samuel has demonstrated a strong commitment to ensuring regulatory compliance, implementing quality programs, and leading teams to achieve success in the biotech and pharmaceutical industries.

Samuel May's education history includes a Master of Business Administration (MBA) degree in Management from Golden Gate University's Ageno School of Business, which they completed in 2010. Prior to that, they obtained a Bachelor's degree in Chemistry (Pre-med) from Brigham Young University in 1995. Samuel also pursued coursework in Graduate Pharmacology at the University of Utah, Medicine at Ross University School of Medicine, and Regulatory and Clinical Science at the University of Southern California. In terms of additional certifications, Samuel obtained a Quality and Regulatory certification from ISPE in January 2010. Samuel also has a certification in Rational Unified Process (Iterative Development Project Management), although the institution and date of obtaining this certification are not specified.