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Limitless High-tech career opportunities - Expoint

MSD Technology Transfer Specialist 
Ireland 
659432126

21.07.2024

Job Description

The Technology Transfer Specialist role will be a Change Champion within the organization and site, to bring about new products, digitization, and ways of working

What you will do

Bring energy, knowledge, innovation to carry out the following:

  • Collaborate with stakeholders to execute the transfer requirements of programs. This may include late stage clinical and/or PPQ (Process Performance Qualification)
  • Attend meetings with local and international groups to coordinate and execute implementation tasks for new Drug Substance processes
  • Collaborate with stakeholders to deliver GMP documents related to TT, such as: Risk assessments, change controls, batch records, sampling plans, Bills of Material.
  • Manage new program introduction schedule to ensure tasks are executed on schedule and right-first-time.
  • Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes
  • Assist in the development of future breakthrough business solutions, to reduce overall effort / reduce risk, optimizing these to make way for rapid product launch, to progress the team forward to “one-click” tech transfer
  • Provide feedback and propose opportunities for optimization to current Tech Transfer processes to incorporate lessons learned.
  • Embody Safe by Choice – know and follow the Safety, Health and Environment guidelines and work towards company safety and environmental goals
  • Ensure the highest Quality, Compliance and Safety standards.


What skills you will need:

In order to excel in this role, you will more than likely have:

  • Minimum of 2 years of work experience in the pharmaceutical or biotech industry
  • Bachelor’s degree in: Engineering, Biotechnology, Chemistry, or related field
  • Has managed a small project with a cross-functional group
  • Familiarity with Unit Operations for mAb manufacturing.
  • Competent in analyzing complex situations and showing practical problem-solving capabilities
  • Understanding of the general principles of New Product Introduction (Tech Transfer)
  • Experience with Microsoft Power Project and PowerBI
  • Familiarity with the use of Automation systems in a manufacturing Process.
  • Competency in the use of automated/digital systems such as DeltaV, MES, eVal
  • Demonstrated experience in a GMP-regulated biological drug substance manufacturing environment, ideally with experience of single-use systems.
  • Validation experience including validation documentation generation and execution
  • Familiarity with risk assessment processes

Current Contingent Workers apply


Not Applicable


*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.



A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.