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Calling all Downstream Bioprocess Scientists, this is a unique opportunity to make real change within the pharmaceutical industry.
I'm working with a client in Ireland who is based within the Biotechnology field. You will be closely working with senior management to make real change in a company who pride themselves on innovation, quality and excellence.

Responsibilities:

• In-depth understanding of the science behind downstream cell culture processes.

• Ability to develop and implement molecule-specific control strategies, including specifications and critical attributes.

• Provide specialised knowledge to the online process support team to enhance process science, operational excellence, and compliance.

• Collaborate with quality assurance, operations, and engineering teams.

• Utilize process monitoring tools to ensure process consistency and robustness through data-driven decisions.

• Understand basic statistical methods and work with statisticians to define specifications, validation criteria, tech transfer criteria, material sampling criteria, comparability assessments, and analyse batch data for reports and reviews.

• Ensure that process parameter requirements are integrated with MES and electronic batch records to meet regulatory, compliance, and process monitoring needs.

• Identify and implement process improvements.

• Ensure compliance with safety, regulatory, and compliance standards.

• Contribute to the authorship and review of regulatory submissions and responses to regulatory agencies.

Requirements:

• 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

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