Robert Corcoran

Robert Corcoran Email and Phone Number

Principal Consultant at Corcoran Quality Consulting @
Robert Corcoran's Location
Greater Boston, United States, United States
Robert Corcoran's Contact Details

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About Robert Corcoran

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

Robert Corcoran's Current Company Details
Corcoran Quality Consulting

Corcoran Quality Consulting

Principal Consultant at Corcoran Quality Consulting
Robert Corcoran Work Experience Details
  • Corcoran Quality Consulting
    Principal Consultant
    Corcoran Quality Consulting Jan 2016 - Present
    Providing GXP consulting support for the biopharmaceutical industry.
  • Merrimack Pharmaceuticals
    Vice President, Quality
    Merrimack Pharmaceuticals 2013 - 2016
    Cambridge, Massachusetts, Us
    Provide 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).
  • Inspiration Biopharmaceuticals, Inc
    Sr. Vice President, Quality
    Inspiration Biopharmaceuticals, Inc 2012 - 2013
    Senior 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.
  • Aegerion Pharma.
    Vice President, Quality
    Aegerion Pharma. 2011 - 2012
    Lead 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.
  • Shire Pharmaceuticals
    Vice President, Quality
    Shire Pharmaceuticals 2006 - 2011
    Tokyo, Jp, Jp
    Responsible 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.
  • Tkt (Transkaryotic Therapies, Inc.)
    Sr. Director, Quality Control
    Tkt (Transkaryotic Therapies, Inc.) 2002 - 2006
    Us
    Established 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.
  • Wyeth Biotech
    Associate Director, Quality Control
    Wyeth Biotech 1989 - 2002
    New York, New York, Us
    Head 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.
  • Smithkline Beecham
    Chemist, Quality Control Stability & Special Projects
    Smithkline Beecham 1986 - 1989
    Brentford, Middlesex, Gb
    Provide 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.
  • Chesebrough-Ponds Usa
    Chemist, Process & Quality Control
    Chesebrough-Ponds Usa 1985 - 1986
    Provide QC analytical support for bulk excipient and chemical manufacturing operations. Maintain instrumentation and standard operating procedures. Generate, review and approve data and final reports.
  • Cell Products, Inc.
    Chemist, Process Development & Control
    Cell Products, Inc. 1983 - 1985
    Provide QC analytical support for process development and fermentation facility manufacturing operations.

Robert Corcoran Skills

Quality Quality Assurance Quality Control Quality Systems Validations Regulatory Affairs Site Inspections Manufacturing Operations Supply Chain Operations Product Development Methods Development Laboratory Automation Laboratory Analysis Lims Quality Management Operational Excellence Continuous Improvement Quality System V&v Validation Laboratory Gmp Clinical Development Pharmaceutical Industry Regulatory Submissions Fda Analytical Chemistry Biotechnology Sop Capa Biopharmaceuticals 21 Cfr Part 11 Glp Gxp Aseptic Processing Gcp Cleaning Validation Drug Development Ind Lifesciences Change Control Technology Transfer Life Sciences Standard Operating Procedure U.s. Food And Drug Administration

Robert Corcoran Education Details

  • University Of Massachusetts Lowell
    University Of Massachusetts Lowell
    Biological Sciences
  • The Catholic University Of America
    The Catholic University Of America
    Biological 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?

Robert Corcoran's email address is co****@****hoo.com

What is Robert Corcoran's direct phone number?

Robert Corcoran's direct phone number is (617) 441*****

What schools did Robert Corcoran attend?

Robert Corcoran attended University Of Massachusetts Lowell, The Catholic University Of America.

What are some of Robert Corcoran's interests?

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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