Group Leader Spotlight

Denise L. Miller-Group Leader, Quality Assurance

Denise L. Miller, Group Leader of Quality Assurance, is responsible for guiding the company in support of the preparation of Toxicology and Phase I/Phase II Clinical Trial Materials. This role requires directing, working with, and providing instruction to Quality Staff and support to Project Directors. In addition, as the Group Leader of Quality Assurance, she is to ensure the effective execution of the necessary procedures in completing a project using her working knowledge of appropriate methods, techniques, and compliance with all associated regulatory requirements.

Denise began her career with Lyophilization Technology, Inc. in 2008, joining the Quality Assurance Group in 2014. Over the years, through her experience and dedication to learning quality and understanding the different aspects of processing and lyophilization, she was promoted to Quality Assurance Associate, then Quality Assurance Compliance Specialist, and her current role as Group Leader, Quality Assurance. Before joining LTI, Denise was an allied healthcare professional, working directly with patients in the field. This experience provides the additional patient-first dedication required when working with clinical material. 

Denise has published and presented various presentations at focused industry events. She is also a member of the American Society of Quality (ASQ). Denise focuses on ensuring clients receive the highest quality and safe lyophilized drug products for their patients. 

Ralph G. Shults-Group Leader, Maintenance Team

Ralph G. Shults is the Maintenance Team Group Leader. He has extensive experience in the maintenance, repair, and service of a wide range of machinery and equipment. His troubleshooting skills are exceptional in HVAC, refrigeration, and pressure systems especially when focusing on Lyophilizers and steam sterilizers. He also has an extensive background in aseptic fill finish for lyophilized materials. 

Ralph began his career in the United States Navy as an Aviation Support Equipment Technician. He leveraged off the skills and leadership in the military when he joined the pharmaceutical field as a Lead Manufacturing Technician and Lyophilization Operator at American Pharmaceutical Partners from 1998 through 2008. Ralph joined LTI in 2008 as a Clinical Manufacturing Technician II, quickly advancing to Lyophilizer Maintenance Technician, and his current role as Group Leader. He has completed several courses related to HVAC, refrigeration, PLC controls, and electrical fundamentals. Ralph’s diligence, critical thinking, and hands-on mechanical aptitude has proved invaluable to LTI.  

To schedule a meeting about your lyophilization needs, please contact Bob Cashman, VP of Business Development at [email protected] or CLICK HERE to fill out the information to initiate the next project.