Wayne Hardy

Wayne Hardy Email and Phone Number

Quality Head at Vector BioMed @
Wayne Hardy's Location
Washington DC-Baltimore Area, United States, United States
Wayne Hardy's Contact Details
About Wayne Hardy

25+ years of management experience in the Biotechnology (including Cellular Therapy), CMO oversite and management, Medical Device (including IVD’s), and Pharmaceutical industries with expertise in Assay Development (including biological threat agent assays), Cell Culture (MAB, viral, bacterial) Development, Technology Transfer, Manufacturing/Operations Management, and Quality System Regulations (specializing in: Risk Management and Root-Cause-Analysis; Design, Process, Environment, and Production Controls) in regulated (GMP 820/ISO 13485) environments.

Wayne Hardy's Current Company Details
Vector BioMed

Vector Biomed

Quality Head at Vector BioMed
Wayne Hardy Work Experience Details
  • Vector Biomed
    Quality Head
    Vector Biomed Mar 2023 - Present
  • Ellume
    Vp Operations
    Ellume Apr 2021 - Nov 2022
    East Brisbane, Qld, Au
    View
  • Kite Pharma
    Neoantigen Site Head
    Kite Pharma Oct 2018 - Mar 2021
    Santa Monica, California, Us
    A Gilead Sciences company, focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors
    View
  • Organovo, Inc.
    Senior Director, Head Of Manufacturing
    Organovo, Inc. Aug 2014 - Oct 2017
    San Diego, California, Us
    Organovo designs and creates multi-cellular, dynamic and functional human tissues for use in drug discovery and medical research. Organovo's proprietary 3D bioprinting technology enables the creation of tissues that mimic key aspects of native tissues.
    View
  • Next Healthcare, Inc.
    Vp Of Quality And Technical Operation
    Next Healthcare, Inc. Feb 2010 - Aug 2014
    A start-up FDA regulated Biotech Company specializing in providing tissue and cell storage solutions to the general public for personalized healthcare solutions.
  • Next Healthcare, Inc.
    Consultant (Quality, Regulatory, And Operations)
    Next Healthcare, Inc. 2010 - 2014
  • Precision Bioservices
    Consultant (Head Of Quality)
    Precision Bioservices Oct 2013 - Mar 2014
    Fredrick, Md, Us
    View
  • Hi-Ficiency
    Owner
    Hi-Ficiency 2008 - 2014
    Quality System Regulations Consulting in Biotechnology, Cell Therapy, and IVD's
  • Pathsensors, Inc.
    Director Of Operations
    Pathsensors, Inc. 2010 - 2012
    Baltimore, Md, Us
    View
  • Pearl Lifesciences Partners
    Qsr Consultant
    Pearl Lifesciences Partners 2009 - 2010
  • Advance Medical Optics/Abbott Medical Optics
    Qsr Consultant
    Advance Medical Optics/Abbott Medical Optics 2008 - 2009
  • Bioveris
    Director Operations
    Bioveris 2006 - 2008
    Us
    View
  • Atcc
    Director, Tech Transfer
    Atcc 2004 - 2006
    Manassas, Va, Us
    View
  • Osiris Therapeutics
    Director, Manufacturing & Process Development
    Osiris Therapeutics 1995 - 2003
    Us
    View

Wayne Hardy Skills

Biotechnology Technology Transfer Fda Gmp Cell Culture Quality System Pharmaceutical Industry Quality Assurance Life Sciences Molecular Biology Iso 13485 Cell Medical Devices Validation Microbiology Lifesciences Assay Development Manufacturing Program Management R&d Biopharmaceuticals Cell Biology Infectious Diseases Sop Glp Commercialization Capa Immunoassays Regulatory Affairs U.s. Food And Drug Administration Pcr Cgmp Process Simulation Diagnostics Quality Systems Cell Based Assays Process Development Process Improvement Continuous Improvement Auditing Qsr Process Validation Change Control Design Control Aseptic Processing Qc Qpcr Contract Manufacturing Root Cause Analysis

Wayne Hardy Education Details

  • University Of Maryland
    University Of Maryland
    Microbiology

Frequently Asked Questions about Wayne Hardy

What company does Wayne Hardy work for?

Wayne Hardy works for Vector Biomed

What is Wayne Hardy's role at the current company?

Wayne Hardy's current role is Quality Head at Vector BioMed.

What is Wayne Hardy's email address?

Wayne Hardy's email address is wb****@****ast.net

What is Wayne Hardy's direct phone number?

Wayne Hardy's direct phone number is +141098*****

What schools did Wayne Hardy attend?

Wayne Hardy attended University Of Maryland.

What skills is Wayne Hardy known for?

Wayne Hardy has skills like Biotechnology, Technology Transfer, Fda, Gmp, Cell Culture, Quality System, Pharmaceutical Industry, Quality Assurance, Life Sciences, Molecular Biology, Iso 13485, Cell.

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