Manufacturing, Quality & Supply Chain executive with more than 25 years experience in the human, animal health pharmaceutical, medical device and cosmetic industries; leading a global external manufacturing supply chain network and multi-plant in house operations.• Manage FDA, EMA, MHRA, VMD, MAPA, APVMA and EPA regulated operations with diverse technologies spanning the globe.• Set up and manage the production, quality, supply chain and technology transfer of a broad range of sterile and non-sterile pharmaceutical dosage forms, medical devices and also experienced in biological, vaccines, and active pharmaceutical ingredients manufacturing• Lead organizations and people through restructuring and site turnarounds. Proficient in developing and embedding a culture of continuous improvement. As an executive, I’m comfortable on the plant floor as well as in corporate leadership committees.• Build business relationships and oversee 3rd Party manufacturing, supply, and quality operations across the globe.Core Competencies:• Start Ups, Manufacturing, Quality & Supply Chain Management• Contract Manufacturing & Negotiations• Team Leadership & Development• Quality, Supply Chain, Safety & Environmental Management Systems • Plant turnarounds & Mergers• Strategic & Project Planning
Mab
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Happily Working At RetirementMab May 2022 - Present
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Executive Director, Technical OperationsColorescience Mar 2018 - May 2022Greater New York City Area -
Executive Director Of Quality & Contract ManufacturingColorescience Oct 2014 - Mar 2018Greater New York City Area
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PrincipalDelgany Llc Mar 2012 - Sep 2014Greater New York City AreaProvides consulting services to Life Science Companies.Specializes in developing processes that deliver predictable outcomes thereby providing clients with a Competitive Advantage, focusing on Manufacturing, Quality, Supply Chain, Environmental, Health, Safety & Performance Management Systems.Secured by major firms in a variety of roles including: Plant Management, FDA Preparation, CMO Development, Project Management.
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Head External Manufacturing & Specialty Pharmaceutical OperationsMerck Animal Health Aug 2008 - Jan 2012New JerseyDeveloped & executed an overall strategic vision for External Manufacturing with the following key pillars:- Focus on supply reliability, compliance & cost improvement- Establish a Virtual Factory Model to manage the business- Rationalize low impact CMOs (Contract Manufacturing Organizations)- Develop strategic CMOs
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Director Global Supply Chain ManagementSchering-Plough Jan 2007 - Aug 2008New Jersey• Developed a supply chain strategy to bring the manufacturing unit as close as possible to the customer by introducing Vendor Managed Inventory (VMI) i.e. plants have visibility and manage the stock levels at the Distribution Centers (DCs) and strategy effectiveness is monitored through Key Performance Indicators (KPIs). • Enhanced VMI supply management by introducing buffer stock levels at the DCs thereby reducing backorders from in excess of $10M to $500K.• Managed the Quality, Safety, Supply and Financial performance of 14 manufacturing sites through monthly KPI conference meetings. Also managed the introduction of new products, working closely with the plants and Technical Services to develop sustainable processes.
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Site General ManagerSchering-Plough Jan 2001 - Dec 2006LouisianaDeveloped & executed an overall strategic vision to improve the site’s performance by focusing on:- Leadership Development- Building Robust Processes- Introducing Sound Management Systems e.g. OSHA's VPP program and - Facility and Equipment Upgrade leading to the introduction of major new products at the site.
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Operations MangerSchering-Plough Jan 1997 - Dec 2000• Lead the implementation of Oliver Wight Class A Business Excellence System, significantly improving Customer Service Level (CSL) .• Transferred a wide range of technologies, e.g. liquids, suspensions,granulation, tableting, pastes, pulse release bolus from E.U. and U.S. facilities.• Acted as Interim Plant Manager at Segre, France and assessed the site with regard to its ability to achieve FDA accreditation. • Streamlined work practices, e.g. raw material sampling now performed by warehouse staff, previously carried out by Quality.
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Production ManagerMallinckrodt Jan 1993 - Dec 1996Bray, Ireland• Developed a versatile organizational structure to facilitate ongoing expansion and movement of people to the point of need. • Streamlined work practices through the development and promotion of a continuous improvement culture by introducing work cells involving all operating functions, Quality, Production, Engineering and Warehouse staff thereby promoting teamwork and ensuring the production schedule was executed on time.• Implemented manufacturing and planning M.R.P. systems. -
Quality MangerGlaxosmithkline Dec 1986 - Dec 1992Ireland• Established the Quality Control and Quality Assurance Departments. (Green field operation).• Set up Quality Systems, e.g.documentation, change control..etc.• Validated sterile and non-sterile production plants, equipment and processes.• Transferred and integrated technologies from the E.U. and the U.S. and achieved FDA & EMA approval • Site EMA Qualified Person (QP)
Michael B. Education Details
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Chemistry, Biochemistry & Microbiology
Frequently Asked Questions about Michael B.
What company does Michael B. work for?
Michael B. works for Mab
What is Michael B.'s role at the current company?
Michael B.'s current role is Executive Director, Technical Operations.
What schools did Michael B. attend?
Michael B. attended University College Cork.
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Michael B.
Greater Chicago Area -
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Michael B.
Senior Software Engineer & Innovation Enthusiast | Full Stack Development | Seeking New ChallengesMiami, Fl
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