Tech Transfer Specialist P2 22648

As a Technology Transfer Specialist, you will play a pivotal role in New Product Introduction (NPI) while contributing to the site's evolving technology transfer strategy. You will be a Change Champion, driving innovation, digitization, and new ways of working.

Key Responsibilities

• Collaborate with stakeholders to execute transfer requirements for late-stage clinical and/or Process Performance Qualification (PPQ) programs.

• Coordinate and implement tasks for new drug substance processes in partnership with both local and international teams.

• Manage new program introduction schedules to ensure on-time, right-first-time execution.

• Develop and deliver GMP-compliant documents related to technology transfer, such as risk assessments, change controls, batch records, sampling plans, and Bills of Material.

• Support process development activities, including facility fits, process descriptions, and process models for continuous and fed-batch manufacturing.

• Identify and implement opportunities for continuous improvement to accelerate product launch.

• Champion Quality, Compliance, and Safety, ensuring adherence to health and environmental guidelines.

• Utilize strong problem-solving skills and an innovative mindset to drive efficiencies in manufacturing processes.

What You'll Need to Succeed

• Minimum 3 years' experience in the pharmaceutical or biotech industry.

• Bachelor's degree in Engineering, Biotechnology, Chemistry, or a related field.

• Strong technical knowledge of biologics drug substance manufacturing, including upstream and downstream processes.

• Understanding of New Product Introduction (NPI) and Technology Transfer principles.

• Familiarity with automation systems such as DeltaV, MES, eVal, and business tools like Power Project and Power BI.

• Experience working in a GMP-regulated environment, ideally with single-use systems.

• Exposure to validation processes, including documentation generation and execution.

• Ability to analyze complex situations and develop practical solutions.

• Strong collaboration, teamwork, and influencing skills to work effectively with global and cross-functional teams.
  
  
  

  The Next Step for you:

  Should this position be of interest to you please submit your CV to Barry O'Mahony from Next Generation Recruitment using the apply button.

  Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical and Operation (permanent, contract and temporary) positions.

  Applications are in strict confidence.

  Next Generation will never share your data outside of our organisation without your prior written consent.

  Please read our Data Protection Policy on our website.