Where Concept and Science Deliver Hope
Ed Trappler has dedicated his professional career to the study, implementation and advancement of the science and technology of lyophilization. In 1992, he founded Lyophilization Technology, Inc. to continue his aspiration of establishing a source of scientific and technical services while expanding the knowledge and understanding of lyophilization within the industry. He is actively involved in Business Development, the Scientific Advisory Board, and Marketing.
Ed has over 40 years' experience in lyophilization that ranges from product development to equipment application engineering. His experience in the pharmaceutical industry includes product development, toxicology supply preparation, clinical manufacturing, and parenteral production. Prior to founding the company, he served as a Systems Application Engineer for Hull Corporation. Ed received his Bachelor of Science degree in Chemistry from The College of New Jersey.
Active in promoting lyophilization in the health care industry, Ed has contributed chapters to six books and authored and presented numerous papers and courses in freeze drying across the North American, European and Asian continents. He has received numerous recognitions for contributions to the industry. He is an active member of the PDA, serving on a number of committees, including as chairperson of the Lyophilization Interest Group and Validation Task Force. The PDA awarded him the Gordon Personeous award for his long term contributions to the PDA and the James Agalloco award for his contribution to education. He is also a member of the AIChE, and has been active in and presents for the AAPS, ISPE, and ISL-FD.
Carrie Shults, Director of Operations, provides strategic leadership and operational oversight across manufacturing, development, and maintenance functions. She partners closely with Project Directors and Quality Assurance to support the successful production of toxicology materials and Phase I and II clinical trial supplies. Carrie also contributes her expertise as a member of the Scientific Advisory Board and participates actively on the company's marketing team.
Carrie brings more than 25 years of experience spanning academia and industry. She began her career as a research scientist in pulmonary medicine with a focus on molecular biology. Prior to joining LTI, she held scientific and operational roles at Merck and GlaxoSmithKline.
She joined LTI as a Project Director managing client programs, and her leadership and technical expertise led to successive promotions. She advanced to Associate Director, Development Sciences, where she oversaw scientific, technical, and quality aspects of all development activities, and later to Associate Director, Clinical Manufacturing, responsible for the full scope of sterile manufacturing operations.
Carrie holds a Bachelor of Science in Biology from Neumann University and a Master of Science in Clinical Research from Drexel University. Her research has been published in respected journals including the Journal of Clinical Investigation, Journal of Allergy and Clinical Immunology, and American Journal of Physiology. She has also authored and presented numerous abstracts and posters at professional conferences.
Carrie is an active member of several professional organizations, including AAPS, ACS, ISL-FD, and PDA.
Bob Cashman has recently joined Lyophilization Technology, Inc. as Vice President of Business Development.
Mr. Cashman has more than 30 years of Business Development experience in the sterile sector of the pharmaceutical industry, including senior management positions at AMRI, OsoBio, Catalent and West Pharmaceuticals. Mr. Cashman is well recognized within our industry; serving on the board of the Philadelphia Drug Exchange (PDE) as well as, a previous appointment to head the Scholarship Committee for the Drug Chemical and Allied Trade (DCAT) organization. He holds a bachelor's of science degree from Villanova University.
Amy M. Bosch has been with Lyophilization Technology, Inc. (LTI) for over 20 years and currently holds the role of Associate Director, Development Sciences. She oversees the Development and Process Laboratories, including management of the Development Technicians. She is responsible for scientific, technical, and quality oversight of development activities.
Amy began her career with LTI in 2004 as a Technician. Over the years, she was promoted to Senior Technician, Research Technician, Scientist I/II and to her current role as Associate Director, Development Sciences in 2019. She has been involved in managing client projects including product and process development, clinical and toxicological material preparation, technical support, and troubleshooting. Prior to joining LTI she held a position at GlaxoSmithKline.
Amy holds a B.S. degree from Millersville University in Biology. She has presented numerous poster presentations for industry events and has given lectures on Critical Quality Attributes of Lyophilized Products.
Denise Miller has been with Lyophilization Technology, Inc. (LTI) since 2008 and currently serves as Associate Director of Quality Assurance. She provides strategic oversight of quality operations supporting toxicology and Phase I/II clinical trial materials for sterile, non-sterile, lyophilized and liquid products. In her role, she leads the Quality Unit in ensuring compliance with global regulatory requirements while collaborating cross-functionally with Operations and Project Directors to support successful program execution.
Denise transitioned into Quality Assurance in 2014 and advanced through progressive roles, including Quality Assurance Associate and Quality Assurance Compliance Specialist. She has extensive experience in aseptic processing, parenteral manufacturing, deviation and change control management, batch record review, and risk-based quality systems. Her leadership focuses on maintaining regulatory alignment while driving operational effectiveness and continuous improvement.
Denise began her career in allied healthcare, working directly with patients in a clinical setting, which is an experience that continues to shape her patient-first approach to quality leadership. She has published and presented on quality systems and technical aspects of lyophilized products and is an active member of the Parenteral Drug Association (PDA) and the American Society for Quality (ASQ).
Kim A Michele holds the position of Finance Manager at Lyophilization Technology, Inc. overseeing the Accounting and Finance Operations of the company as this company continues to grow and expand all areas of operation. She began working with LTI in 2018 as a consultant. Kim has over 30 plus years of experience in Accounting, Business Analytics, Cash Management, Human Resources and Compliance Management. The majority of Kim's experience has been in the Retail Sector most recently for Sears Holdings Corporation located in Hoffman Estates, IL. She has held many titles and lead Business Analytic teams at District, Regional and Corporate levels and has served as a Senior Analyst and Corporate Operational Compliance Manager where her team developed a Retail Compliance Document to assist store locations to identify and correct deficiencies, while updating any changes that came about through updates to Federal, State and Local Laws and Regulations. This electronic document replaced a procedure manual that was in place for nearly 50 plus years. She has worked many years on transition projects converting manual systems to electronic/scan-based systems to improve operational efficiency and productivity. Kim's background also includes experience as a Controller in the Manufacturing Industry and a Consulting Engineering Firm in Western New York.
Kim has attended Holy Family University and the University of Hawaii (Manoa) and holds a BS Degree in Business Administration. She continues her pursuit of Knowledge while presently attending classes at Princeton University. Kim has served on Community and Educational Boards in the Delaware Valley and has been actively involved with the March Of Dimes, Lupus Foundation and the Variety Club both in Western New York and Philadelphia.
Ralph 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.
Joseph joined Lyophilization Technology, Inc. in 2019 and currently serves as Group Leader, Clinical Manufacturing. In this role, he directs and manages aseptic processing operations for the preparation of sterile and non-sterile GMP toxicology and clinical trial materials. Joseph directly supervises Manufacturing Technicians and leads cross- functional teams to coordinate and execute clinical manufacturing activities, including batch preparation, lyophilization, filtration, filling and finishing, environmental monitoring, SOP development, and validation studies.
Progressing through roles of Clinical Manufacturing Technician I and II, Manufacturing Lead, and now Group Leader, Joseph has built extensive hands-on and leadership experience in cGMP-regulated environments. He oversees scheduling, equipment readiness, utility sampling, material management, and the overall condition and compliance of the Clinical Manufacturing Area. He is also responsible for coaching and developing technical staff, supporting project timelines and budgets, and driving continuous process improvements to enhance productivity while maintaining the highest standards of quality and safety.
Prior to joining LTI, Joseph held pharmaceutical manufacturing roles at Johnson Matthey Pharmaceuticals and Wedgewood Pharmacy, where he gained experience in API production, milling operations, chromatography, environmental testing, and compounding operations within ISO and cGMP frameworks.
Joseph earned a Bachelor of Arts in History from Rowan University and has completed extensive industry training and certifications, including OSHA HAZWOPER, DOT, IATA, and RCRA. With a strong foundation in aseptic processing, team leadership, and operational excellence, Joseph is committed to delivering high-quality clinical manufacturing solutions while fostering a collaborative and performance-driven environment.
