Analytical Contractor

194870
  • United Kingdom
  • Contract

We are seeking an experienced Analytical Consultant with a strong background in process characterization and comparability for biologics. The ideal candidate must have direct experience authoring source documents from scratch and contributing to the analytical sections of a Biologics License Application (BLA). This role requires deep expertise in analytical development for Biologicals (recombinant proteins preferred) including PHIII development. 

Key Responsibilities:

  • Lead analytical development strategies to support process characterization, method validation, and comparability studies for biologics.
  • Author and review source documents from scratch, ensuring alignment with regulatory expectations and industry best practices.
  • Draft and finalize analytical sections of a BLA filing.
  • Provide expert guidance on analytical comparability assessments to support process changes, scale-up, and technology transfers.

Required Experience:

  • 10+ years of experience in analytical development for biologics, with hands-on experience in process characterization and comparability.
  • Proven track record of authoring regulatory source documents and analytical sections for a BLA submission.
  • Strong knowledge of analytical method validation, bioassays, physicochemical characterization, and impurity profiling.
  • Excellent technical writing and communication skills with the ability to convey complex analytical data clearly.

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Holly Wallner Recruitment Manager

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