Critical thinking, analytical and multifaceted professional with demonstrated accomplishments in the areas of business development, research and development, quality assurance/operations, manufacturing, and alliance management within the pharmaceutical industry. Successfully led global cross-functional due diligence teams by leveraging their diversity, strengths, and experiences. Self-motivated and accomplishment oriented individual who is able to effectively operate in an ambiguous/changing environment.
Critical thinking, analytical and multifaceted professional with demonstrated accomplishments in the areas of business development, research and development, quality assurance/operations, manufacturing, and alliance management within the pharmaceutical industry. Successfully led global cross-functional due diligence teams by leveraging their diversity, strengths, and experiences. Self-motivated and accomplishment oriented individual who is able to effectively operate in an ambiguous/changing environment. Proven business acumen and ability to negotiate across cultures including Europe, Asia, and the Emerging Markets.
Director - Business Development @ Lead, support, evaluate, and execute internal and external business development and commercial activities in the areas of licensing, supply, distribution, co-marketing, acquisitions, divestitures, sale of manufacturing facilities, quality, and restructuring of business relationships. Managed divisional revenue generation account that generated several hundred million dollars from executed supply, distribution, and out-licensing/intellectual property agreements. Facilitated and managed several third-party alliance relationships. Interviewed, trained, and mentored new business development professionals in the areas of the negotiation skills, strategy development, due diligence, and financial modeling. From 2005 to Present (10 years) Manager - Business Development @ From 1999 to 2005 (6 years) Senior Project Quality Assurance Analyst - Manufacturing Division @ Conducted cGMP audits for internal manufacturing facilities and external contract manufacturing vendors that supplied active pharmaceutical ingredients, drug products, sterile/injectables, and fermentation/biological products; developed and implemented remediation plans for identified gaps in compliance. Chaired the manufacturing division's process change control committee. Authored divisional policies, procedures, guidelines, quality alerts, position papers, and training guides in support of ongoing corporate quality initiatives. From 1996 to 1999 (3 years) Research Pharmaceutical Scientist @ Developed and optimzied formulations and manufacturing processes for several ethical and over-the-counter products marketed in the United States and European countries. Authored chemical and manufacturing control sections for New Drug Applications, Abbreviated New Drug Applications, and World Marketing Authorizations. Supervised staff pharmacists and engineers in the development and implementation of research studies and manufacture of clinical supplies. From 1990 to 1996 (6 years) Lead Supervisor - Quality Operations Laboratories @ Supervised chemists and laboratory technicians in the testing and release of raw materials, active pharmaceutical ingredients, and drug products. From 1989 to 1990 (1 year) Pharmaceutical Process Engineer @ Developed, optimized, and transferred drug product formulations and manufacturing processes from pilot to commercial scale for several marketed ethical products. Supervised staff engineers in the development of clinical supplies. Managed several capital expansion projects through equipment installation and qualification. From 1987 to 1989 (2 years)
MBA, Finance @ Saint Joseph's University - Erivan K. Haub School of Business From 1992 to 1995 B.S., Pharmacy @ University of the Sciences in Philadelphia From 1984 to 1987 Biochemistry and Statistics @ Penn State University From 1981 to 1984 Scott Kleinbart is skilled in: Quality Assurance, quality operations, Licensing, Supply Chain Management, Pharmacists, Due Diligence, mergers and acquisitions, Contract Negotiation, New Business Development, Drug Development, Quality Auditing, Emerging Markets, Financial Modeling, pharmaceutical research, Divestitures
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