Jamie Griffiths

Senior Manager at Pharmaron
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Contact Information
us****@****om
(386) 825-5501
Location
UK
Skills

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Cristin Clinton

I reported to Jamie as my Team Leader for my time in Actavis Biologics LTD. Jamie is an excellent manager, with fantastic people skills. He was always knowledgeable and pleasant to deal with.

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Credentials

  • PRINCE2® Foundation Certificate in Project Management
    AXELOS Global Best Practice
    Nov, 2018
    - Nov, 2024
  • IOSH Managing safely
    EEF
    Mar, 2008
    - Nov, 2024
  • BSc Human and Applied Biology
    University of Liverpool
    Sep, 2005
    - Nov, 2024
  • PRINCE2® Practitioner Certificate in Project Management
    AXELOS Global Best Practice
    Nov, 2018
    - Nov, 2024

Experience

  • Pharmaron
    • China
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Senior Manager
      • Nov 2016 - Present

      Responsible for managing Cell line development group and CMC lead for Drug Substance of gene therapy projects Responsible for managing Cell line development group and CMC lead for Drug Substance of gene therapy projects

  • AstraZeneca
    • United Kingdom
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Process Leader
      • Aug 2015 - Nov 2016

      Manager of the Services Team responsible for Zoladex. • Leading the service group of 17 operators across 2 plants and 11 seperate areas to support the manufacture of Zoladex ensuring equipment is available to guarantee that process and packing can occur. • Manage plant water systems ensuring water quality meets specification. • Investigate deviations and implement effective CAPA. • Facilitate engineering support to allow minimum disruption to equipment availability. • Front audits and provide action plans for follow up tasks. • Supervising and training of functional groups within the company. • Review and sign off plant documentation linked to batch release.

  • Pharmaron Biologics (UK) Ltd
    • United Kingdom
    • Biotechnology Research
    • 100 - 200 Employee
    • Upstream Team Leader
      • Aug 2012 - Jul 2015

      Organise daily batch work for a complex mammalian fermentation process to tight internal deadlines for clinical trial material and validation requirements. Line managing a team of 4 operators and 1 senior operator providing regular 1:1 feedback, ensuring H&S is adhered to, and setting up development programmes.Front audits and provide action plans for follow up tasks.Providing and executing optimisations for processes and ways of working using lean manufacturing operational excellence tools such as 5s, Kaizen, and standard work.Investigate non-conformances and initiate corrective and preventative actions to ensure the process is improved.Supervising and training of functional groups within the company.Generation of cGMP documentation including, MI’s, SOPs, QMS and validation documents.Performing external supplier and filling house inspections and audits providing observations of findings.Initiating a technical transfer team to establish GMP processes from a process development idea.Liaising with a variety of departments and clients to provide successful outcomes.Ensure all health and safety requirements are met, being the department health & safety representative, COSHH team, and company first aid group leader.

    • Senior cGMP Operator
      • Oct 2009 - Sep 2012

      Leading CMO projects.Involved in tech transfer of processes between PD and production.Preparation of Quality documents including SOPs/MI’s for quality control.

    • cGMP Operator
      • Mar 2009 - Oct 2009

      Operating CMO projects to cGMP.Adhering to SOP’s/MI’s.Involved in CAPA, NCR, CCR, TCR.Being involved in environmental monitoring and upkeep of facility.

  • Intercytex Ltd
    • Biotechnology
    • 1 - 100 Employee
    • Associate Scientist II
      • Oct 2005 - Mar 2009

      Direct line managing, and involved in mentoring and training of production scientists. Production of cellular based therapeutic products for clinical use to cGMP. Production coordinator for Cyzact® development, analysis, and BLA for regulatory submissions. Direct line managing, and involved in mentoring and training of production scientists. Production of cellular based therapeutic products for clinical use to cGMP. Production coordinator for Cyzact® development, analysis, and BLA for regulatory submissions.

Education

  • Liverpool Hope University
    Bachelor’s Degree, Human and Applied Biology

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