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Principal Downstream Bioprocess Scientist

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Regina Carroll
+353 86 010 0903
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Principal Downstream Bioprocess Scientist

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Principle Downstream Bioprocess Scientist 

Our client is a global healthcare leader and they are looking for people who are determined to make life better for people around the world.

The Principal Downstream Bioprocess Scientist will be responsible for providing technical support for the introduction of manufacturing processes into the downstream operations/manufacturing environment through the startup and into routine manufacturing operations.
The successful applicant will have technical expertise in downstream bioprocessing and experience in data-driven decision-making and problem-solving capabilities.

They will also work to continuously improve process performance by implementing new technologies and process improvements. They will maximize the benefits of a digital plant to gain in depth knowledge of the process through data analytics and process analytical technology. 

In this role you will : 
  • Have In-depth knowledgeable of the science of downstream cell culture processes and understand molecule-specific control strategy and basis of specifications and critical attributes
  • Understand purpose and capability of each downstream unit operation and the impact of equipment on the process
  • Provide technical expertise to the online process support team for process science, operational excellence and compliance
  • Work as part of a cross-functional team at the interface between quality assurance, operations and engineering to bring deep technical expertise and scientific rigor to the team
  • Utilize process monitoring tools to make data driven decisions to ensure process consistency and robustness
  • Understand basic statistical methodologies engage with statisticians to assign specifications, validation acceptance criteria, tech transfer criteria, material sampling criteria, comparability assessments and analysis of batch data for summary reports and product reviews
  • Understand integration of process parameter requirements with MES/electronic batch records to ensure all regulatory, compliance and process monitoring needs are captured in manufacturing electronic documentation
  • Identify process improvements and participate in implementation of Lean Manufacturing initiatives
  • Generate scientific reports and technical documentation
  • Understand and ensure compliance with safety, compliance, and regulatory expectations
  • Contribute to the authorship and review of regulatory submissions and responses to regulatory agencies 
  • Bachelors, Masters or PhD qualification in relevant scientific discipline such as Engineering, Biology, Chemistry, Microbiology, etc.
  • Minimum of 5 years’ experience in the Biopharmaceutical industry.

For more information on this role please contact Regina Carroll  086 0100903 or  

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