Mr. Karras joined Noramco in April, 2020, as Group Chief Executive. Prior to that he was a Director at SK Capital providing operational, sales and general management guidance to SK Capital portfolio companies in the healthcare sector.
Most recently, Mr. Karras served as CEO of Halo Pharmaceuticals Inc, an SK Capital Partners portfolio company that was sold to Cambrex Corp in 2018. Prior to Halo, he was President of IBA Molecular North America (also an SK Capital Partners portfolio company) that was sold to Illinois Health and Sciences in 2015. Prior to IBA, Mr. Karras was President and CEO of AAIPharma Services Company where he led the company’s transition from bankruptcy to a successful exit in 2009. Prior to AAI, Lee held various positions at Baxter Healthcare and Cook Medical (Cook and Baxter Pharmaceutical Solutions) where he served as General Manager and helped build the pharmaceutical services start up into a sizable sterile injectable pharma services business.
Lee holds a bachelor’s degree in chemistry from Indiana University Bloomington and a Masters of Science in Environmental Science from Indiana University Bloomington School of Public and Environmental Affairs.
Josh Hoerner is the General Manager of Purisys, LLC (a subsidiary of Noramco) and heads all operations for the business. Josh also serves as the Vice President and Head of Noramco R&D, serving on the Noramco Executive Leadership Team. During his tenure at Noramco/Purisys over the last 10+ years, Josh has held a variety of technical and business roles, significantly expanding the business’s product portfolio and leading modernization of its key manufacturing technologies. In 2019, Josh co-led the formation of Purisys LLC, a market leader in small volume custom synthesis as well as specialized controlled substance manufacturing. Prior to working at Noramco/Purisys, Josh served as a Principal Scientist and Market Formulation Development Leader at Merck & Co., where he was responsible for integrated product development and lifecycle management strategy of Zontivity, Boceprevir, and Liptruzet. Josh holds a B.S. in Chemistry from Hobart College and Ph.D. in Chemistry from the University of Massachusetts Amherst.
Amanda Haynes is the Controlled Substance Compliance Manager and Head of Security at Purisys, LLC. Amanda oversees Purisys’ controlled substance compliance to ensure material accountability and prevent diversion, as well as leading all interactions with law enforcement, including the US Drug Enforcement Administration (DEA). Amanda also manages the six DEA registrations the site has, encompassing 48 different drug codes. During her tenure at Noramco/Purisys over the last 34 years, Amanda has held various roles and responsibilities encompassing technical, operational, and quality aspects of the business serving as a principal contributor to quality and compliance.
Rajgopal (Raj) Munigeti is the Quality Assurance Manager of Purisys, LLC and heads site quality. Raj joined Purisys over four years ago with a decade of experience in the Pharmaceutical CDMO industry. During his tenure at Purisys, Raj has held various technical and compliance roles. As the Reference Standard Program Lead, Raj has expanded the product offering and co-led the expansion of our reference standard service offerings. Raj also led ISO accreditation for the Purisys Reference standard program. Prior to Purisys, Raj served as a Global Chromatography and Spectroscopy lead at Avery Dennison and as a Pre-formulation Scientist/Lead at Ricerca Biosciences (currently Olon Ricerca Bioscience), where he helped multiple customers in discovering stable solid-state forms of various APIs. He also holds multiple patents in this area. Raj, a certified Quality Auditor holds a Bachelors in Pharmaceuticals Sciences from Rajiv Gandhi University of Health Sciences, India and an M.S. in Chemistry from the Cleveland State University, Ohio.
Charla Barr is the Director of Regulatory Affairs at Purisys, LLC. Charla has worked with the company for over 10 years and has held several positions, including Director of Product Development and Regulatory CMC, Senior Manager of Process R&D and Engineering, and Senior NPI Program Manager. Prior to working at Noramco, Charla worked as a Principal Scientist at Ricerca Biosciences (currently Olon Ricerca Bioscience) and before that, The Lubrizol Corporation. She holds a Ph.D. in Organic Chemistry from The Ohio State University and is PMP certified through the Project Management Institute.
Mark Dobish is the Senior Manager of Program Management and External Manufacturing at Purisys, LLC. Mark leads Purisys’ global supply chain of regulatory starting materials, custom intermediates, and active pharmaceutical ingredients. He also manages the internal implementations of commercial and developmental products. Mark started with Noramco as a Process Scientist over 10 years ago and has contributed to or led several development efforts of the commercial offerings from Purisys, including Cannabidiol and Dronabinol. Mark’s experience on the bench facilitated his transition to project management, and later program management, where he oversees the entire process from bench discovery to regulatory submissions. Mark holds a Ph.D. in Organic Chemistry from Vanderbilt university, where he was the author/co-author of six publications, ranging from enantioselective organo-catalysis to medicinal chemistry to large scale syntheses.
Jim Davis is the Senior Manager of New Product Introduction at Purisys, LLC and leads project management activities for the business unit. Jim joined Purisys in Oct 2022. Prior to working at Noramco/Purisys, Jim served in various industries including pharmaceutical (focused on API’s and scale up), medical device, consumer health, chemical industry, and filtration. Jim served in various scientific, technical, operations, quality, business development, team management, and project management roles at Imerys, Mölnlycke, Novartis, and Alcon for 25 years. He was responsible for the technical development of Harborlite, SuperCel, Mepilex Ag, Mepitel, Safetac, Olopatadine, PataDay, AcrySof, Systane, OPTI-FREE product portfolios. Jim holds a B.S. in Chemistry from Henderson State University, an M.S. in Inorganic Chemistry and a Ph.D. in Analytical Chemistry from the University of North Texas.
Amber Burch is the Senior Manager, Technical Business Development of Purisys, LLC (a subsidiary of Noramco) and manages customer relationships and contractual negotiations for CDMO, clinical and custom manufacturing projects. Amber started with the organization in 2017 and has held various technical and customer-facing roles within the organization. Upon the formation of the Purisys subsidiary, Amber supported the growth and expansion of the custom manufacturing and reference standards business units. Prior to joining Noramco, Amber worked as a process chemist at Wilmington PharmaTech, where she assisted in process optimization, and first time cGMP scale up of various APIs for customers. Amber holds a B.S. in Chemistry from The College of New Jersey (TCNJ) and a Ph.D. in organic chemistry from the University of Delaware. Outside of work, Amber enjoys spending time with her family, her pets and watching sports.
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