President, Owner, and Operator
Sarah is the President, owner and operator of Kymanox. She funded Kymanox during its start-up and first year of operation and has led the following areas at Kymanox: Business Operations, Sales and Marketing, Client Services, and Human Resources.
Prior to Kymanox, Sarah held positions of increasing responsibility for market development at J. P. Morgan Chase , Oakwood Corporate Housing, Texas Guaranteed (TG), Keller Graduate School of Management, Northwestern University, and North Carolina State University. Sarah graduated from Saint Mary’s College with a Bachelor’s of Arts degree. She is a member of Project Management Institute (PMI), Women in BIO, and Parenteral Drug Association (PDA).
Stephen is the CEO and founder of Kymanox. He has over 20 years of CGMP biopharma manufacturing experience as a process engineer, project manager, and regulatory advisor. Before starting Kymanox, Stephen held various leadership roles supporting successful scale-up, start-up and commercialization initiatives at M+W Group, Abbott Laboratories, Covance Biotechnology Services, Diosynth Biotechnology and Human Genome Sciences.
Stephen graduated with high honors with a degree in Chemical Engineering from the University of Notre Dame. He has also studied at the graduate level at Purdue University. Stephen speaks regularly as an industry expert on technology transfer, project management, risk management, and validation.
Senior Director, Client Services
Ash is an accomplished Supply Chain (CSCP) and Operations Director with more than 20 years of experience in Supply Chain, Quality & Manufacturing Operations, Engineering, Capital Projects, Validation, and IT/Automation systems. He oversees all aspects of sales, marketing, and business development at Kymanox. He has general management experience in multi-national biotech companies with a strong focus on compliance, change management and value creation.
Ash also has highly developed communication and leadership skills to coach, manage, and motivate diverse professionals in challenging environments. International and domestic assignments that encompass plant expansions, Global Supply Chain and Global Footprint Expansion in the Asia Pacific and Latin America Regions with clear knowledge, experience and implementation of relevant regulatory requirements (e.g., EMA, FDA).
Kevin brings over twenty years of technology and systems integration experience to Kymanox including extensive expertise in the development and project management of large-scale, on-demand applications.Kevin has spearheaded the integration of internet technologies into all aspects of the business, including the development of CMOLocator and KymaSTORE.
Kevin is also experienced in Computer Software Validation, helping clients achieve FDA approval on software for pharmaceuticals and medical devices.
Kevin graduated with honors from the University of Notre Dame with a Bachelor of Business Administration and a concentration in Management Information Systems. Kevin is PMP Certified and a member of the Triangle Technology Executives Council (TTEC) and the Project Management Institute.
Senior Manager, Quality + Compliance
Nathan Blazei is the Senior Manager of the Quality + Compliance group at Kymanox. Nathan has been an integral member of the Kymanox audit team and the Food and Drug Administration (FDA) response team for the past 3 years, working with clients domestically and internationally to achieve compliance with Current Good Manufacturing Practice (CGMP) regulations for drug products and the Quality System Regulation (QSR) for medical devices.
He has nearly 15 years of health care industry experience spanning biologics, biopharmaceuticals, pharmaceuticals, medical devices, and combination products. He is skilled in various quality management system tools, and he has written sections of regulatory filings at various times in his career.
Manager, Atlanta Operations
Mitchel Kevern heads up the Atlanta office for Kymanox. He is also a senior project manager with focuses on Process Operations, Engineering, Quality, Regulatory Compliance, and Validation.
Mitchel has experience in the medical device, biopharmaceutical, and biotech industries developing processes, authoring and implementing standard operating procedures (SOPs), co-authoring regulatory submissions, auditing quality systems, validating equipment and computer systems, and managing multi-million dollar projects.
Director, Manufacturing Operations
Rich Motruk is the Director of Manufacturing Operations, with responsibliity of leading both the Validation and Process Engineering teams at Kymanox. Rich has Extensive experience in many aspects of medical device and pharmaceutical manufacturing and management, including quality assurance, manufacturing, engineering, maintenance & reliability, tech transfer, clinical research and continuous improvement. Proven ability to recruit, motivate and coach both highly educated and skilled professionals as well the production floor work force.