Biopharmaceuticals Professional

4 days ago

Dublin, Dublin City, Ireland beBeeQualification Full time €135,000 - €165,000

Job Title: Quality Director

About the Role:

We are seeking an experienced Quality Director to join our team in Dublin on a 12-month contract. As a key member of the team, you will provide scientific and regulatory leadership across assets, with responsibilities spanning analytical methods, specifications, reference standards, and comparability approaches.

Main Responsibilities:

  • Develop and execute analytical CMC strategy for late-stage assets transitioning to commercialisation.
  • Provide scientific expertise in the lifecycle management of analytical strategies across commercial products, including specification setting, method lifecycle management, reference standards, and comparability studies.
  • Serve as a subject-matter expert in analytical sciences, advising on cross-functional matrix teams and ensuring alignment with regulatory expectations.

Required Skills and Qualifications:

  • A Ph D, MS, or BS in Biological Sciences, Chemistry, or related disciplines with at least 15+ years of biologics experience within an analytical CMC / relevant field.
  • Extensive knowledge and hands-on experience in analytical CMC for biologics, including specification setting, analytical comparability strategy and risk assessments, method lifecycle and change control, and reference standard strategy.
  • Proven track record of independently authoring complex regulatory and scientific documents, such as justification of Specifications, analytical comparability protocols/reports, scientific briefing packages, responses to health authority questions.

What We Offer:

  • An opportunity to work with a leading Biopharmaceutical client.
  • A dynamic and collaborative work environment.
  • The chance to develop your skills and expertise in analytical CMC.

Contact Us:

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