Technology Transfer Manager

Are you ready to lead complex tech transfer programmes within a science driven manufacturing environment?

Do you have the expertise to scale small molecule products from development into commercial GMP production?

Can you guide cross functional teams to achieve right first time, inspection ready manufacturing?

Fraser Dove International is partnering exclusively with a leading science driven pharmaceutical manufacturing organisation. Operating in Ireland, they are committed to delivering high quality, compliant manufacturing solutions for complex and high value pharmaceutical products.

Our client is seeking a strategic and technically strong leader to head up all technology transfer activities across development and GMP manufacturing.

Discover more about our Tech Transfer Manager opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.

As the Head of Technology Transfer, you will be measured against the following objectives:

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• Deliver seamless end to end technology transfer from Process Research and Development into GMP manufacturing, achieving right first time batch execution.
  
• Build and lead a high performing technology transfer function that drives best practice, strong governance, and cross functional alignment.
  
• Ensure all transferred processes meet global regulatory expectations, including International Council for Harmonisation guidelines, and support successful inspections and product launches.
  

As the Tech Transfer Manager, your duties and responsibilities will include:

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• Lead the technology transfer function across small molecules drug substance and drug product.
  
• Act as the primary technical liaison between process development, analytical, manufacturing, quality, and project management teams.
  
• Oversee end to end transfer from kilo lab scale through to commercial GMP production, including risk assessments, control strategies, and validation planning.
  
• Review and approve technology transfer documentation, master batch manufacturing records, change controls, and Failure Modes and Effects Analysis.
  
• Provide technical oversight of scale up activities, including solid phase complex molecule synthesis, purification, lyophilisation, and impurity profiling.
  
• Support regulatory submissions and lead technical interactions during regulatory inspections by authorities such as the HPRA, FDA, and EMA.
  
• Develop and mentor a multidisciplinary team of process chemists and engineers, embedding a culture of continuous improvement and operational excellence.
  

These are the skills and experience you will need to succeed as the Tech Transfer Manager:

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• 10+ years of GMP experience within a pharmaceutical or biotechnology manufacturing environment, with significant exposure to technology transfer and scale up.
  
• Proven leadership of technology transfer, process development, or Manufacturing Science and Technology teams in a regulated setting.
  
• Deep technical knowledge of small molecule drug substance and drug product manufacturing, including API synthesis, formulation and fill finish processes, analytical method transfer, and process validation including process performance qualification.
  
• Strong understanding of Quality by Design, critical process parameters, and commercial manufacturing requirements.
  
• Demonstrated experience supporting regulatory inspections and submissions within a global manufacturing environment.
  
• Degree qualified with a BSc, MSc, or PhD in Chemical Engineering, Organic Chemistry, Pharmaceutical Sciences, or a related discipline.
  
• Excellent project management, stakeholder engagement, and risk management skills, with the ability to manage multiple complex programmes in a fast paced environment.
  

Got what it takes? xcfaprz

To apply for the Tech Transfer Manager, click the ‘Apply’ button below or contact the Executive Search Consultant on

Please Note:

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job