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William (Bill) B. Wiederseim, President & CEO
PharmaBioSource, Inc.
Mr. Bill Wiederseim has been a consultant to the pharmaceutical, chemical and automotive industries for more than twenty years. He is the co-founder and First Executive Director of The Consortium for the Advancement of Manufacturing in Pharmaceuticals (CAMP), a non-profit research consortium for the Pharmaceutical Industry, MIT and Purdue University. Mr. Wiederseim is the founder and primary person responsible for the overall development of PharmaBioSource.
Andrew A. Signore, PE, Partner
Mr. Signore has more than twenty-five years of experience in the pharmaceutical industry with SmithKline Beecham, Pfizer and Merck. He has served as the President of the International Society for Pharmaceutical Engineers (ISPE) and received the association's Lifetime Achievement Award. Mr. Signore is the co-founder and President of IPS, a fully integrated engineering firm specializing in clean, compliant industries.
Sean P. McKee, Partner
Mr. McKee has over 18 years of experience in the pharmaceutical industry with proven success in scientific research and operations. He has significant experience in managing large capital projects with regard to planning, designing and construction in a variety of new laboratory facilities valued at over $850MM. Mr. McKee also has significant experience in the acquisition of facilities and has performed several due diligence surveys.
Charles M. Shafran, Partner
Mr. Shafran's Life Sciences career at Pfizer spanned 37 years in diverse roles, and he retired as Vice President of Strategic Planning for Pfizer's Global Manufacturing Division. His career includes line production management, the management of Pfizer' s US engineering operations, leadership of Pfizer's Global Manufacturing IT organization and, for the last ten years, the leadership of Global Manufacturing's strategic planning activities. In this role, his responsibilities included management of the integration of the Warner-Lambert and Pharmacia manufacturing networks into the Pfizer plant network and the subsequent divestiture of surplus manufacturing sites, and active participation on the corporate acquisition and divestiture teams for the many businesses that Pfizer acquired or sold. Mr. Shafran holds BS and M.Eng. degrees in Chemical Engineering from Cornell University and an MBA from the University of Connecticut.
Ashok K. Soni, P.E., Board Member
Mr. Soni has 26 years experience in a broad range of environmental engineering and strategic consulting for industry, the majority of which has been to the pharmaceutical sector. He is widely recognized for his technical and regulatory knowledge in the environmental field, and for guiding clients through environmental compliance in a manner which meets the clients’ business objectives. He is the President and founder of IES. He holds a BS in Chemical Engineering, an MS in Water Resources Engineering, and is a registered Professional Engineer.
John J. Braithwaite, Advisory Board
Mr. Braithwaite was President and CEO of Accupac (retired), a leading contract manufacturing company serving the Pharmaceutical Industry. Currently, Mr. Braithwaite is the President of PharmaSource Consulting, Inc., a consulting company serving the Pharmaceutical Industry. Mr. Braithwaite is an active member of PharmaBioSource’s Industry Advisory Board.
 Olga Morales-Ventura, R.Ph., M.S.
Ms. Morales has more than 15 years of experience in the areas of pharmaceutical technology, quality assurance, and regulatory compliance while maintaining ties with academia via a part-time Visiting Professor appointment at the UPR School of Pharmacy Industrial Pharmacy Program.
Joseph J. Tarantino, Jr., Managing Partner PharmaBioSource Realty, LLC
Mr. Tarantino is a licensed broker with more than 30 years of experience in the Real Estate Industry. He has held many official positions in the real estate industry including Chairman of the Pennsylvania State Real Estate Commission, Chairman of the Pennsylvania Association of Realtors, and Federal District Coordinator of the National Association of Realtors. Mr. Tarantino is also consultant to several banking organizations as well as the Montgomery County (PA) Planning Commission and the Pennsylvania Turnpike Commission.
Kiirsten Suurkask, M.S.
Ms. Suurkask has strong life sciences strategic and operational consulting experience. Past projects include strategic planning, market assessments, and medical product development and commercialization. Ms. Suurkask holds a Bachelor of Science in Biology from Harvard University, a Master of BioScience from Keck Graduate Institute of Applied Life Sciences and also holds a Regulatory Affairs Certification in medical products from the Regulatory Affairs Professional Society.
William T. Hensler, Ph.D.
Dr. Hensler is a Biochemical Engineer with eighteen years of international cGMP pharmaceutical manufacturing, quality assurance and engineering experience, with particular emphasis on production of bulk biopharmaceuticals including cytokines, monoclonal antibodies, vaccines and blood products. He has extensive knowledge of manufacturing compliance, validation and regulatory requirements for bulk biopharmaceutical facilities according to US FDA, EMEA and ICH regulations (API's and final dosage forms). Dr. Hensler is technically proficient on many aspects of biopharmaceutical processing, with emphasis on large scale bulk production and process validation.
Amany Mansour-Awad, R.Ph., MBA
Ms. Mansour-Awad has strong business development experience in the United States, Europe and Japan. She has completed several pharmaceutical projects in the US, Europe and Japan, and is a registered pharmacist in Pennsylvania and New Jersey. Most recently, Ms. Mansour-Awad served as the Far Eastern representative for an international pharmaceutical consulting firm operating in Tokyo. Ms. Mansour-Awad has an EMBA from Temple University.
Dr. Carina E. A. Sonnega
Dr. Sonnega has a broad background in the manufacture of pharmaceutical and biological products in Europe. She has broad and significant experience in project management, Q/A, technology transfer, manufacturing and site consolidation. Dr. Sonnega is fluent in Dutch, French and English.
Duane Dunham, M.S.
Mr. Dunham is the former Chairman, President and Chief Executive Office for Bethlehem Steel and sits on several boards. Mr. Dunham has also been a member of the Lehigh Valley Partnership, the Lehigh Valley Economic Development Corporation and the Pennsylvania Society.
Scott Schultz
Mr. Schultz is an information systems specialist with over 15 years experience in the design, implementation and management of corporate information and communication technologies. His experience includes the design, development and implementation of real time barcode inventory and labor reporting systems as well as performing and directing corporate information systems validations to ensure adherence to FDA regulations.
Joel Zicot
Mr. Zicot is an engineer with a broad range of international experience in the technical aspects of pharmaceutical manufacturing processes - engineering / commissioning / maintenance / optimization / validation. His technical knowledge in the area of production includes: powder processes, IBC's technology, packaging equipment (blisters, bottles, sachets), powder and liquid (aseptic) filling, handling systems, tableting machines, coating, capsuling machines, onguent, blending, granulation, drying (fluid bed dryer, spray dryer, freeze dryer) compaction, sterilization (autoclaves, UV, tunnel), solvent storage, explosion proof (EEX) area, centrifugal dryers, primary chemical plant.
Susan E. O’Donnell, M.A.
Ms. O’Donnell has over ten years experience in the management of public health and regulatory issues with respect to pharmaceuticals, medical devices and consumer products. She has extensive benchmarking and database creation experience. Past projects include biologic outsourcing study, finished dosage form study and the development of a life sciences investment strategy for a prominent energy company.
Carole A. Phelps
Ms. Phelps has over 10 years of experience in Life Sciences administrative project management. While working at the executive level, Ms. Phelps has been responsible for the management of the administrative structure of several senior level offices. Her responsibilities have included contact with potential and current clients, proposal editing and execution, development of project and technical manuals and the drafting, editing and final development of reports submitted to the client.
Amy K. O’Neill
Ms. O’Neill has three years of experience within the non-profit industry and five years of progressive experience within the financial services industry, specializing in software application testing. She has been responsible for leading a team of software application testers and mentoring team members by teaching and coaching throughout project life cycle and final release. Ms. O’Neill also has a Bachelor of Science degree in Elementary Education.
Georgia Struthers, JD
Ms. Struthers is an expert in complex research and information analysis. She has been a research analyst to a variety of chemical companies in North and South America. She has also studied regulatory issues related to the chemical industry ranging from deregulation to supply contracts.
Roseanne Schwiegerath
Ms. Schwiegerath is a chemist with more than 20 years of experience in Pharmaceutical R&D analytical research. She has expertise in Analytical Research, method development, method validation, stability testing, raw materials testing and technology transfer to manufacturing. She is also experienced in preparation and editing of IND and NDA submissions to FDA.
M. L. Jaisimha (Jai)
Mr. Jaisimha lives in Secunderabad, India, and has over 26 years of Life Science experience including 13 years as National Sales and Exports Manager with Lee Pharma Ltd and JSM, Shenzhen, China. He is an expert at sourcing API and dosage forms in India and China. He has been involved in merchant trading, sourcing for export, helping companies with making an entry into regulatory markets, and with country-specific product registrations. Mr. Jaisimha has also assisted companies with preparations of drug master files, technical transfer, logistics, compliance and contract negotiations.
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PharmaBioSource, Inc., 121 West Wayne Avenue, Wayne, PA 19087 Phone: 610.293.0900 Fax: 610.293.6907 |
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