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Experienced Bio-Pharmaceutical Technical Operations Consultant with 25+ years in GXP Quality Assurance, Quality Control, Analytical Development, Regulatory, Product Development, Manufacturing & Supply Chain.Specific areas of expertise include: GxP Quality Assurance/Control; Quality Systems; Validation; Regulatory CMC Submissions; Regulatory Compliance; Pre-Approval Inspections; Operational Excellence (OE); Stability Programs; Analytical Methods Development & Validation; Manufacturing Operations; Supply Chain Operations, Product/Process Development/Control; Strategic Long Range Planning & Budget Management; Technology Transfer
Corcoran Quality Consulting
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Principal ConsultantCorcoran Quality Consulting Jan 2016 - PresentProviding GXP consulting support for the biopharmaceutical industry.
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Vice President, QualityMerrimack Pharmaceuticals 2013 - 2016Cambridge, Massachusetts, UsProvide senior leadership for all GxP Quality functions in support of fully integrated pharmaceutical manufacturing, supply chain and clinical operations. Support development of multi-product/platform (small molecules/nanoliposome/biologics) in the oncology therapeutic area. Transform the Quality organization from clinical development phase support to full commercial capabilities. Ensure quality systems are robust and pre-approval inspection (PAI) ready. Provide support for regulatory submission and approval strategy for MM-398 (nanoliposome irinotecan). -
Sr. Vice President, QualityInspiration Biopharmaceuticals, Inc 2012 - 2013Senior leadership position responsible for global QA/QC GxP functions in support of biopharmaceutical product development (hemophilia therapeutic area ), manufacturing, distribution, and product registration of IXinity rhFIX, Obizur rpFVIII. Member of executive management team (EMT), reporting to COO/CEO of company; also member of management team responsible for asset liquidation in response to company Ch. 11 bankruptcy, resulting in potential $1B product value.
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Vice President, QualityAegerion Pharma. 2011 - 2012Lead all GxP Quality Operations activities supporting Juxtapid (lomitapide) product development, registration and launch planning. Oversee virtual GxP operations through establishment of robust Quality Systems, vendor selection, and compliance oversight.
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Vice President, QualityShire Pharmaceuticals 2006 - 2011Tokyo, Jp, JpResponsible for executive management of the Global Quality Operations Department (200+ global personnel), including Quality Assurance, Quality Systems, Quality Control Laboratory, Validation, and Operational Excellence. Responsible for all quality oversight of Shire's Human Genetic Therapies (HGT) rare disease division. Developed an implemented global Quality infrastructure US, EU, Latin America. -
Sr. Director, Quality ControlTkt (Transkaryotic Therapies, Inc.) 2002 - 2006UsEstablished and led the TKT Quality Control Group, enabling product approvals, laboratory expansions, global regulatory inspections, global product support through distribution. Managed the function through several product approvals (Replagal, Elaprase) through the TKT acquisition by Shire Pharmaceuticals. -
Associate Director, Quality ControlWyeth Biotech 1989 - 2002New York, New York, UsHead of QC Analytical Sciences and Technology group. Responsible for biologic product characterization assays including peptide mapping, carbohydrate fingerprinting, amino acid analysis, ELISA, cell based bioassay; as well as analytical method optimization, tech transfer, qualification, validation, and troubleshooting. Also responsible for the development and management of the product stability program for bulk and finished drug product. -
Chemist, Quality Control Stability & Special ProjectsSmithkline Beecham 1986 - 1989Brentford, Middlesex, GbProvide QC analytical support for pharmaceutical manufacturing operations. Design and execute product stability studies. Review and approve data and final reports. Maintain analytical equipment and standard operating procedures. -
Chemist, Process & Quality ControlChesebrough-Ponds Usa 1985 - 1986Provide QC analytical support for bulk excipient and chemical manufacturing operations. Maintain instrumentation and standard operating procedures. Generate, review and approve data and final reports.
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Chemist, Process Development & ControlCell Products, Inc. 1983 - 1985Provide QC analytical support for process development and fermentation facility manufacturing operations.
Robert Corcoran Skills
Robert Corcoran Education Details
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University Of Massachusetts LowellBiological Sciences -
The Catholic University Of AmericaBiological Sciences
Frequently Asked Questions about Robert Corcoran
What company does Robert Corcoran work for?
Robert Corcoran works for Corcoran Quality Consulting
What is Robert Corcoran's role at the current company?
Robert Corcoran's current role is Principal Consultant at Corcoran Quality Consulting.
What is Robert Corcoran's email address?
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What is Robert Corcoran's direct phone number?
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What schools did Robert Corcoran attend?
Robert Corcoran attended University Of Massachusetts Lowell, The Catholic University Of America.
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Robert Corcoran has interest in Advisory Board Member.
What skills is Robert Corcoran known for?
Robert Corcoran has skills like Quality, Quality Assurance, Quality Control, Quality Systems, Validations, Regulatory Affairs, Site Inspections, Manufacturing Operations, Supply Chain Operations, Product Development, Methods Development, Laboratory Automation.
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