Analytical Contractor
194870
Posted: 28/01/2025
- 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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