Executive Team
The Xcelience culture is completely reliant on the quality of our people, and we have shown the ability to attract and retain top talent.
Derek G. Hennecke
President and CEO
Derek G. Hennecke is a founding member, CEO and President of Xcelience. He has a long history of growing strong businesses around the world. Blending a scientific and business background, he has nearly two decades of international experience in the healthcare industry and a track record as a highly successful international turn-around manager in the global development community. Xcelience is the first company Mr. Hennecke has managed as an owner, having launched a management buy-out from MDS Pharma Services in 2006. The newly formed company immediately embarked on a robust pattern of strong growth. This growth was recognized in May 2008, when Mr. Hennecke was selected as a finalist for the coveted 2008 Ernst & Young Florida Entrepreneur of the Year award, a nomination based on the demonstration of extraordinary success in the areas of innovation, financial performance, personal commitment to community, and perpetual growth. Mr. Hennecke was also recognized as a finalist for the Ultimate CEO award by the Tampa Business Journal and for the Small Business of the Year award by the Greater Tampa Bay Chamber of Commerce in 2008. Before founding Xcelience, Mr. Hennecke spent more than 10 years abroad working for the Dutch-based conglomerate DSM. In Montreal, he as GM of a 250-staff Biologics plant for more than 2 years. In Cairo, Egypt, as GM, he oversaw a radical turn-around in an anti-infectives plant that had been slated for closure. He spent two years in Holland developing new Pharma intermediates, and two years in Mexico as Commercial Director covering Central and South America. He also worked for Roche, both in Canada and Germany. Mr. Hennecke has a BSc in Microbiology from the University of Alberta and an MBA from the Erasmus University in The Netherlands.
Randall H. Guthrie
Vice President
Randall Guthrie has over thirty years of experience in the Pharmaceutical Services Industry. In his role as Vice President at Xcelience, he oversees all Business Development and Marketing. Prior to the launch of Xcelience, Mr. Guthrie led MDS Pharma Services and legacy Phoenix International, as Vice President of Business Development and Vice President of Strategic Development. With hands on experience that spanned across all five MDS Pharma Services business segments, he is well versed in the drug development continuum, and the needs and requirements of the formulation development process. Prior to 1996, Mr. Guthrie held numerous positions at PPD and the legacy Wisconsin Analytical Research Services. He held positions including Director of Business Development for Phase I Clinical, Bioanalytical and GMP Pharmaceutics. He was the founder of their GMP Services Group and served as Laboratory Director. Mr. Guthrie was instrumental in launching Lancaster Laboratories’ pharmaceutical business where he served as Manager of Pharmaceutical Development Services. He also spent 11 years with Johnson Matthey in which he held roles in Research & Drug Development, Bulk Drug Production, Quality Assurance & Control & Corporate QA. Mr. Guthrie received his BSc degree in Biology from Gannon University in Erie, PA in 1977 and completed several graduate level courses at Pennsylvania State University and West Chester State University. Over the years, Randall has been involved with teaching several quality improvement programs, which included Juran & Philip Crosby. He is currently on the planning committees for the University of Wisconsin School of Pharmacy’s LOL International Industrial Pharmaceutical Research & Development Conference. He helped the University establish both the LOL Bioanalytical conference and Drug Metabolism & Applied Pharmacokinetics. He is an active member of AAPS.
Paul Skultety, PhD
Director, Pharmaceutical Development Services
Paul Skultety has a unique background in pharmaceutical development combining extensive experience with contract development and innovator companies. At Xcelience, he leverages his broad drug development expertise and his successful track record of developing new chemical entities from pre-IND to commercialization, to recommend potential drug development and clinical solutions. These strategies enable pharmaceutical companies to maximize speed to clinic while utilizing less active pharmaceutical ingredient (API). In his leadership responsibility for the Pharmaceutical Development Services division, he oversees a team of highly skilled scientists in the areas of drug preformulation, analytical method development, and formulation development.
Prior to Xcelience, Dr. Skultety held leaderships positions such as Vice President, Pharmaceutics for Quintiles, Director of Solids Formulation Development for Hoechst Marion Roussel (HMR), and various management positions within Marion Merrell Dow and Marion Labs which were predecessors to HMR. He has 9 US formulation and composition patents.
Dr. Skultety holds a B.S. in Pharmacy from the University of Iowa, College of Pharmacy, and a Ph.D. in Pharmaceutics from the University of Iowa, College of Pharmacy. He has written a number of publications. made numerous scientific presentations, and been a member of AAPS since its inception.
Theodore S. Koontz
Director, Operations
Theodore Koontz manages the Manufacturing, Warehouse and Facility Departments at Xcelience. He helps to ensure that all drug products manufactured by Xcelience meet or exceed cGMP requirements, as well as servicing the wide-ranging and stringent demands of Xcelience’s many customers. Mr. Koontz has more than 17 years of industry experience with solid oral dosage forms in the areas of manufacturing, operations, analytical and formulation development. He is renowned for his ability to apply his considerable experience, creativity and knowledge of cGMPs to develop processes which allow customers to utilize unconventional methods to create clinical trial materials that meet a wide variety of needs. As a founding member of the Manufacturing Department when it was part of MDS Pharma Services, Mr. Koontz played the key role in developing the manufacturing systems and facilities, as well as expanding the manufacturing team as the company grew. Mr. Koontz left MDS in 2003 to serve as manager of GMP Operations at Shire Labs, Inc. (currently known as Supernus Pharmaceuticals, Inc.). He returned to Xcelience in 2006 to lead the Manufacturing Department again, and has since taken leadership responsibility for the Warehouse and Facilities Departments. Mr. Koontz also has prior experience with Somerset Pharmaceuticals, Inc., in formulations development and analytical chemistry.
Irene E. LoJacono
Director, Project Management
Irene LoJacono has been responsible for the project management, contracts, and administrative/accounting groups at Xcelience (formerly MDSPS Tampa) for over 11 years. Prior to working at MDSPS, she worked at Bausch & Lomb Pharmaceuticals Division as a Master Planner, and International/Contracts Planner, at Johnson & Johnson as a Forecast/Planning Manager and at Bristol-Myers Squibb as a Master Planner. She is a 38 year veteran in the formulation development industry.
Xcelience Program Management provides a disciplined, centralized point of contact for early phase development projects. Ms. LoJacono leads a team with over 25 years combined experience in managing and optimizing integrated formulation development, analytical and manufacturing programs, and with a strong record of success with technology transfer. Acting as your logistical and scientific interface, members of Ms. LoJacono’s team coordinate scientific and operational resources, and regularly communicate project status to ensure that timelines and budget remain on track as defined in your customized development plan.
Thomas M. Kolessar
Director, Quality Affairs
Thomas Kolessar played a major role in developing the Quality Systems at Xcelience and has been responsible for compliance to Federal, DEA and State Regulations since the start-up of the company in 1998. He has led the company through numerous regulatory inspections of which contributed to a clean regulatory history. Prior to working at Xcelience he was Q.A. Director at Separation Technology and was employed at Wyeth-Ayerst Laboratories for fifteen years where he served in the capacity of GLP and GMP Auditor, Coordinator II-QC, and Supervisor, Stability Services, QA. He has gained the experience and understanding of the governing regulations, including cGLP’s and sGMP’s, and developed a risk-based approach necessary to meet the compliance challenges presented during early stage drug development. He leads a dedicated team of quality assurance experts responsible for ensuring Xceliences’ compliance to current regulations as well as the unparalleled satisfaction of Xcelience’s clients. His education includes a B.S. in Biology from Delaware Valley College, PA.
