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Tech Tranfer Project Manager

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location: Waterford
  • Sector: Engineering
  • Date posted: 21/07/2017
  • Job reference: J370926A

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Tech Transfer Project Manager

Tech transfer Project Manager required to join a leading Pharmaceutical company in the South East. Role will involve supporting the R&D department in ensuring Tech Transfer requirements are delivered timely and accurately. Reporting directly to the head of the R&D department.

Responsibilities:

  • Ensure efficient Tech Transfer through the full life cycle, from planning, development testing, and process performance qualification through to regulatory submission
  • Develop and maintain the Tech Transfer plan, detailing timing and dependencies for each transfer activity and expected milestones for meeting the acceptance criteria of achieving valid Tech Transfer
  • Ensure Tech Transfer is executed flawlessly first time, meeting all expectations, and ensuring appropriate comparability of product
  • Define and state all regulatory expectations and responsibilities, along with the regulatory milestones and outputs linked to the Tech Transfer effort
  • Define transfer acceptance criteria
  • In conjunction with the project team draft the Tech Transfer protocol
  • Track and control the project budget
  • Initiate Tech Transfer Risk Assessment and Change Control
  • Work with internal and external Quality departments to facilitate audits of facilities, equipment & material suppliers
  • Devise and coordinate the planning and implementation of R&D projects in line with the direction of the Head of R&D
  • Plan, schedule and track project deliverables using appropriate tools ensuring all parties understand their own deliverables
  • Constant monitoring, problem solving and reporting on project progress to all stakeholders
  • Manage project resource allocation in line with direction of the Head of R&D
  • Co-ordinate and run R&D project meetings
  • Ensure that all work is carried out in compliance with the required standards to conform to company, cGxP, health and safety, environmental and regulatory requirements.

Qualifications & Experience:

  • Qualified to Honours Degree level in an appropriate science discipline, preferably Biotechnology
  • Project management qualification such as, Project Management Professional is desirable
  • Minimum five years' experience within the pharmaceutical industry, preferably in a Biopharma Project Management role
  • Significant exposure to Tech Transfer projects across the full life cycle and ideally have worked within an aseptic fill finish environment
  • Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations.
  • Must possess exceptional written and oral communication skills allowing direct interaction with all key project stakeholders

For more information contact James on 016455250 or email

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