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Laboratory Manager - Next Generation Product (NGP) Liverpool United Kingdom

Laboratory Manager - Next Generation Product (NGP)

Permenant | Wellington House, Physics Road | Liverpool | United Kingdom | L249HP

As Laboratory Manager you will provide Next Generation Product (NGP) QC Operational/Innovations leadership. Ensuring all laboratory activities (Operational/Innovations) are conducted to the agreed regulatory standards. You will lead development of analytical & scientific technology/knowledge within the NGP Innovations business.

 

Key Accountablitites 

  • Implementation of QC standards and adherence to ongoing compliance requirements
  • Lead and/or support project teams developing new or improving existing analytical methodologies
  • Assist/manage with QC qualification/validation review/approval activities
  • Determine & communicate ‘Best Practices’ for harmonization of laboratory standards 
  • Implement and develop key performance indicators from laboratory data to drive improvements within the business
  • Define & implement ‘Best Practice’ inspection/testing regimes for all manufactured goods based on legislative/industry e.g. FDA, MHRA
  • Participate on cross-functional teams to support QC relevant business & technology improvement activities
  • Harmonise analytical methodologies to ensure that comparative analysis can occur throughout the business
  • Define and manage laboratory processes and standards to deliver regulatory compliance and a high quality of scientific data
  • Support business on internal/external audit program
  • Implement and develop safe working practices and training to ensure a safe working environment within laboratory Plan & prioritise laboratory workloads to deliver operational requirements, regulatory submissions and science / technology projects, as directed by the business
  • Liaise with Technical Operations and Compliance & Regulatory teams as needed in order to maintain compliance to regulatory & customer requirements
  • Management & implementation of standards, policies, procedures, and forms to control GxP laboratory activities
  • Provide Subject Matter Expert (SME) support to support NGP activities
  • Manage/support implementation of ISO standard(s)

 

 

Skills & Experience 

  • Excellent people person with a ‘can do’ approach
  • Ability to work effectively in a fast-paced environment & comfortable with continual change
  • Demonstrated ability to lead, define, create and implement laboratory processes across NGP Innovations business
  • Excellent oral & written communication skills for effectively interfacing with all levels of management and departments within the internal/external business
  • Strong technical, analytical, and writing skills to identify and solve problems and document them appropriately
  • In-depth knowledge of GxP i.e. GLP (Good Laboratory Procedures), GMP (Good Manufacturing Practices), GDocP (Good Documentation
  • Practices), GCPs (Good Clinical Practices) and TPD (Tobacco Products Directive)
  • Demonstrated project management experience and leadership skills, with the ability to coordinate multiple projects in a demanding fast-paced environment
  • Ability to work independently with strong team building skills essential
  • Demonstrate an excellent level of understanding of Pharmaceutical qualification/validation principles in relation to maintaining GxP compliance

 

Qualifications:

  • Extensive experience in a QC laboratory management role within a GxP environment, project management role or combination thereof within a pharmaceutical or similar development setting required
  • Area of expertise preferred:  Laboratory Management, Project Management, GxP, Regulatory and/or Nicotine products
    Degree or higher in Chemistry, Pharmaceutical Sciences, or related scientific discipline is desirable

 

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