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Hands-on leader with comprehensive experience and increasing scope of responsibility in pharmaceutical quality control/quality assurance. Successful track record of building and enhancing GMP quality systems and operations for newly launched products and product expansions, managing pre-approval inspection readiness and leading GMP compliance remediation efforts. Diversified knowledge of pharmaceutical operations, including the manufacturing, packaging, quality control and distribution of commercial and clinical trial material solids (tablets, capsules, hot melt extrusions), semi-solids, oral liquids, topicals, parenterals, biologics, radiopharmaceuticals, combination products (multidose pen and co-packaged inhalers), active pharmaceutical ingredients and bulk drug substances.Specialties: Quality ManagementPharmaceutical Quality AssuranceGMP, GCP, GLP and Part 11 ComplianceQuality SystemsAlliance Management
Osorio Pharmaceutical Quality Consulting, Llc
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Pharmaceutical Quality ConsultantOsorio Pharmaceutical Quality Consulting, LlcFlorham Park, Nj, Us
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Pharmaceutical ConsultantOsorio Pharmaceutical Quality Consulting, Llc Jul 2023 - Present
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Member Scientific Advisory BoardXbxbio (Formerly Fast Trac) Jul 2020 - Present
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Chief Quality OfficerProvention Bio Dec 2021 - Jul 2023
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Senior Vice President QualityProvention Bio Aug 2020 - Dec 2021Head of Quality responsible for GMP, GCP and GLP compliance
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Chief Operating OfficerProgenics Pharmaceuticals, Inc. Mar 2019 - Jul 2020Responsible for Quality, Analytical Sciences, Manufacturing and Facilities
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Senior Vice President, QualityProgenics Pharmaceuticals, Inc. Feb 2018 - Mar 2019Head of quality assurance (GMP, GCP, GCP and GLP) and quality control/analytical sciences
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Vice President Quality AssuranceAcorda Therapeutics, Inc. Jun 2016 - Feb 2018Pearl River, New York, UsHead of GMP, GCP, GVP and GLP Quality Assurance -
Vice President, Compliance And Quality AssuranceAchillion Pharmaceuticals, Inc. May 2014 - May 2016Blue Bell, Pennsylvania, UsHead of GCP, GLP and GMP compliance -
Vice President, Quality OperationsValeant Pharmaceuticals North America Llc May 2013 - Oct 2013Head of Quality Operations for North America, including GMP/GCP/GLP quality assurance and quality control laboratories.
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Global Head, Qa/QcBraeburn Pharmaceuticals, Inc Jan 2013 - May 2013Development, implementation and communication of the company's global quality strategy and programs.
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Senior ConsultantComplya Consulting Group Dec 2012 - Dec 2012Provided GMP consulting services to biopharmaceutical manufacturing companies.
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Vice President/Senior Vice President QualityProgenics Pharmaceuticals, Inc. Jul 2005 - Sep 2012New York, New York, UsMost senior executive responsible for quality assurance, quality control and analytical development. Also served as the alliance manager with worldwide co-development and marketing partners -
Director/Senior Director, Gmp ComplianceForest Laboratories 2001 - Jul 2005UsProvided GMP compliance assessments of Forest internal and third party manufacturing, testing, R&D and API sites and standardized quality systems across sites. Developed and implemented programs for updating Forest senior management and site management on the current GMP compliance landscape and the state of Forest GMP compliance. Led site compliance remediation efforts. -
Manager/Director/Executive Director, Quality AssuranceThe P.F. Laboratories Inc. (Purdue Pharma) 1984 - 2001Developed and implemented quality assurance and GMP compliance policies relating to the manufacturing, packaging, control and distribution of drug products for the Purdue Pharma Manufacturing and Distribution companies during a period of significant sales growth.
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Senior ChemistBerlex Laboratories 1979 - 1984Analyzed raw materials and prescription and OTC finished drug products
Benedict Osorio Skills
Benedict Osorio Education Details
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Seton Hall UniversityBusiness (Finance) -
Seton Hall UniversityChemistry (Analytical) -
John Jay College (Cuny)Forensic Science
Frequently Asked Questions about Benedict Osorio
What company does Benedict Osorio work for?
Benedict Osorio works for Osorio Pharmaceutical Quality Consulting, Llc
What is Benedict Osorio's role at the current company?
Benedict Osorio's current role is Pharmaceutical Quality Consultant.
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What schools did Benedict Osorio attend?
Benedict Osorio attended Seton Hall University, Seton Hall University, John Jay College (Cuny).
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Benedict Osorio has skills like Research, Chemistry, Microsoft Excel, Microsoft Word, Powerpoint, Customer Service, Microsoft Office, Program Management, Teamwork, Social Media, Social Networking, Leadership.
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