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External Manufacturing Lead at Regeneron Pharmaceuticals Inc. Responsible for Commercial & Clinical Manufacturing, Contract Manufacturing and Packaging &Labeling globally. Manufacturing Leader with broad range of experience in project management, regulatory compliance and quality systems.Specialties: * Production & Operations Management * OE & Continuous Process Improvement * Project Management * Technology Transfer & NPI * cGMP & Regulatory compliance* HPRA, FDA and MRHA
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Executive Director External ManufacturingRegeneron Dec 2023 - PresentTarrytown, New York, Us
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Senior Director External ManufacturingRegeneron Dec 2020 - Dec 2023Tarrytown, New York, Us
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Director Drug Product External ManufacturingRegeneron Jun 2018 - Dec 2020Tarrytown, New York, Us
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Associate Director, External ManufacturingRegeneron Dec 2016 - Jun 2018Tarrytown, New York, UsCoordination of all aspects of clinical and commercial parenteral drug product filling operations including overseeing day-to-day operations, ensuring timely completion of associated operations/documentation and assisting in the monitoring of cGMP compliance at European drug product contract manufacturers
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Senior Project ManagerRegeneron Aug 2015 - Dec 2016Tarrytown, New York, UsCoordination of all aspects of clinical and commercial parenteral drug product filling operations including overseeing day-to-day operations, ensuring timely completion of associated operations/documentation and assisting in the monitoring of cGMP compliance at European drug product contract manufacturers
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Sterile Fill Finish Manufacturing Cell LeaderGenzyme Ireland Limited Nov 2009 - Jul 2015Paris, France, FrProviding leadership to the Sterile Fill Finish Cell Team encompassing Manufacturing, Maintenance and Quality operations in compliance with regulatory guidelines -
Manufacturing ManagerWyeth Medica Ireland May 2008 - Nov 2009Management of resources within the manufacturing area to ensure a strong focus and linkage to key business objectives whilst maintaining a best of class performance against a background of quality, cost and customer service.
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Fda Project ManagerWyeth Pharmaceuticals Feb 2006 - May 2008New York, New York, UsSuccessfully led the Wyeth Newbridge FDA program for sites first product registration in the USA -
Epc Regulatory Affairs Project LeaderPfizer Apr 2005 - Nov 2005New York, New York, UsSuccessfully led the EPC Regulatory Affairs project team responsible for assuring regulatory compliance of drug product and drug substances with market authorisations, quality agreements and quality systems.
Michael O'Loughlin Skills
Michael O'Loughlin Education Details
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Technological University DublinPharmaceutical Technology -
National College Of IrelandLine Management
Frequently Asked Questions about Michael O'Loughlin
What company does Michael O'Loughlin work for?
Michael O'Loughlin works for Regeneron
What is Michael O'Loughlin's role at the current company?
Michael O'Loughlin's current role is Executive Director External Manufacturing.
What is Michael O'Loughlin's email address?
Michael O'Loughlin's email address is mi****@****zer.com
What is Michael O'Loughlin's direct phone number?
Michael O'Loughlin's direct phone number is +3538793*****
What schools did Michael O'Loughlin attend?
Michael O'Loughlin attended Technological University Dublin, National College Of Ireland.
What skills is Michael O'Loughlin known for?
Michael O'Loughlin has skills like Gmp, Fda, Quality System, Manufacturing, Technology Transfer, Change Control, Operations Management, Aseptic Processing, Validation, Project Management, Software Documentation, Pharmaceutical Industry.
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