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Leadership at Sovereign

We have a growing team of innovators in the CDMO space. They're the best in the business, and our people tend to stay around for a long time.

Paul Hafey

President

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.

Johanna Hunter

Executive Vice President

Johanna Hunter is responsible for all aspects of customer service, production planning, and business development. She joined Sovereign in May 2000 and has held positions of increasing responsibility including Customer Service and Production Planning, Manager, and Senior Manager, Sales and Marketing.

She received her Bachelor of Science degree in Biomedical Science from Texas A&M University in College Station.

Johanna served as a team member for the Fourth Shift Software implementation for both Sovereign and its sister company. She serves as the main contact for customer relations. She is responsible for managing customer accounts by scheduling all sales orders for production. Once the product is packaged she insures the order is shipped to the customer on time. Johanna keeps our customers informed on new developments and how regulatory changes may impact their business.

Kathleen Parker

VP Purchasing

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.

L. Diane Bruce, PhD

Director of Formulation Development

Diane Bruce is responsible for product pre-formulation, formulation development, scale-up, site transfer, and support of the eCTD modules and sections for all ANDA, NDA and ANADA submissions.

Dr. Bruce has over 20 years combined experience in pharmaceutical formulation development and analytical chemistry. She received her doctorate degree in Pharmaceutics from the University of Texas at Austin. She has worked with branded and generic products at KV Pharmaceuticals, and also in contract development and manufacturing of IND, NDA, ANDA FTF (First-to-File), ANADA and OTC products with a variety of virtual to large corporate pharmaceutical clientele while at Quintiles and Aptuit, Inc. Dr. Bruce has experience and expertise in development and processing of immediate, modified, and controlled-release tablets, pellets, and capsules, oral solutions, suspensions, topical creams, gels, and otic solutions. She has given numerous internal company seminars and poster presentations at AAPS, and authored publications on the subject of pharmaceutical modified release coatings, hot-melt extrusion, drug-polymer interactions, and is a contributing author in the current edition of Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms.

Since joining Sovereign in 2010, Dr. Bruce has led a team of development scientists in the successful formulation and development of multiple approved ANDA, NDA and OTC products, meeting strict project timelines and FDA filing deadlines. She has improved the technical quality and through-put in development activities with her leadership and experience in dosage form design, pharmaceutical development, and strong technical writing skills. Her work has also included process improvement, reformulation or improvement of current products, trouble shooting and problem solving in support of manufacturing and packaging process improvements, including corrective and preventative actions.

Jeremy White, PhD

Associate Director, Analytical Development Laboratory

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.

Seth Morgan

Director of Quality Control

Seth Morgan originally  joined the Company as Supervisor of Analytical Development.  Since then he has held the position of Manager, Group Leader and Senior Group Leader at several other CMO organizations before returning to Sovereign as Director of Quality Control in 2018.  He has a Bachelor of Science in Biology with a concentration in Molecular Biology from the University of North Carolina at Pembroke.

Seth started his career as a Control Scientist at DSM Pharmaceuticals before moving onto Merck and Company as an Analytical Chemist in the North American Stability Unit.  He ultimately ended up in a Global Regulatory position supporting audits and annual stability programs before moving on.  Since then Seth has held positions as subject matter expert in regards to stability programs, analytical development and continuous improvement.

As Director of Quality Control, Seth’s almost 20 years’ experience allows him to manage the testing of Raw Materials, In-process, Release and Stability samples efficiently to meet on time delivery.

Ruth Collins, RAC

Manager Regulatory Affairs

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.

Sam Caldwell
Co-Founder, CEO
Pauline Sims
Co-Founder, CFO
Sanj Patel
Technical Lead
Andrew Pearce
Lead Developer
Nils Henriksson
Interface Designer
Olivia Anderson
Experience Designer
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We're in Fort Worth, and we're waiting to meet you…

We've got facilities we're incredibly proud of, and a team that will put your company first. Stop by anytime.

54k sq ft
cGMP Production Facility
14.5k sq ft
cGMP R&D/QC Facility
100k sq ft
Warehouse & Expansion
5.4k sq ft
Storage / Stability Space