Paul Hafey joined the Company as Vice President, Research and Development in 2008 with more than twenty nine years of experience in pharmaceutical operations, quality and research. He was promoted to his current position in October 2016. He received his Bachelor of Arts degree in Chemical Laboratory Administration from Capital University in Columbus, Ohio. He also holds an Associate of Arts degree from The Ohio State University.
Paul began his career as a laboratory technician at Roxane Laboratories, ultimately progressing to Section Head of Quality Assurance and gaining a strong operations background covering laboratory, quality assurance and production functions. He then moved to UCB Pharmaceuticals (formerly Medeva and Celltech) where he oversaw various research and development groups as Manager, Associate Director and Director. During that time, Paul was responsible for numerous functional areas including pre-formulation, formulation, process development, method development and method transfer. He has extensive experience in global product development, product evaluation and protection of intellectual property.
As President of Sovereign, Paul's expertise and experience are assets that help him direct resources effectively, he not only provides oversight of the firm's CGMP capabilities and NDA/ANDA projects but also manages the organizational and ancillary issues that these capabilities and projects require as the Company continues its expansion.
Kathleen Parker joined Sovereign in 1995 as a Quality Control team member. She soon transitioned to Purchasing where she has held various positions of increasing responsibility. As Director of Purchasing, Kathleen is now responsible for the purchase of active pharmaceutical ingredients (APIs), excipient raw materials and packaging components as well as the Company's business supplies.
Kathleen graduated with a Bachelor of Science degree in Consumer Science from Texas Women's University in Denton, Texas.;
Kathleen has developed excellent relationships with our suppliers and maintains an extensive network of contacts in order to assist customers in locating sources for ingredients where FDA acceptance is critical. Likewise for packaging components, she works with customers and suppliers to ensure that our component sources meet product specific dimension and performance criteria.
Jeremy White is responsible for drug substance and drug product analytical method development, commodity evaluations, method validation, formulation support, method transfers, and support of the eCTD modules and sections for all ANDA, NDA and ANADA submissions.
Dr. White has over 15 years combined experience in pharmaceutical method development and analytical chemistry. He received his doctorate degree in Analytical Chemistry from The Ohio State University, in Columbus, Ohio. He started his pharmaceutical career working with branded and generic products at Mylan Pharmaceuticals, where he developed analytical methods for numerous approved ANDA applications. Dr. White has experience and expertise in method development and formulation support of immediate, modified, and controlled-release tablets, capsules, oral solutions, suspensions, topical creams, gels, and otic solutions.
Since joining Sovereign in 2013, Dr. White has led a team of development scientists in the successful development and validation of over 60 analytical methods that support approved ANDA, ANADA, NDA and OTC products. He serves as the main contact for analytical support at Sovereign and is responsible for post-submission communication with the FDA for all chemistry related questions. He has improved the technical quality and through-put of method development activities with his leadership, experience and strong technical writing skills. Jeremy and his team strive to develop quality, robust and economical methods in support of all Sovereign products from early development to commercialization.
Ruth Collins joined the Company as a Senior Regulatory Affairs Associate in 2012 after 22 years of pharmaceutical experience as a chemist, technical writer, and regulatory affairs associate. She has a Bachelor of Science degree in Chemistry from Bob Jones University and a MBA from Loyola University in Chicago.
Ruth began her career as a chemist with Geneva Laboratories, a contract laboratory in Wisconsin. She has experience with several chromatographic techniques, reviewing new technology for implementation, and the IQ/OQ/PQ of new technologies. She then moved to IVAX Pharmaceuticals (eventually a subsidiary of Teva Pharmaceuticals USA) as a Technical Writer and eventually promoted to Manager of Analytical Services. While leading a group of 10 people including chemists and writers preparing laboratory documentation for submission, she interacted with several of the Regulatory Affairs groups at Teva. Ruth was asked to transfer to Regulatory Affairs to bring her chemistry knowledge to the department while learning the science of regulatory submission with the Agency.
Ruth obtained RAC certification in 2011 and maintains the certification through continuous classes and training. After moving to Sovereign Pharmaceuticals, Ruth continued to provide quality submission including 505(b)(2) NDAs and ANDAs. She was promoted to her current position as Manager in 2017 where she continues to ensure quality submissions and helping client’s plan regulatory strategies.
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