BioTalent
Manager Analytical Development
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Group Leader, Analytical Development
We are currently seeking an experienced Group Leader, Analytical Development to provide technical leadership across a portfolio of monoclonal antibody (mAb) programmes for a fast-growing biosimilars organisation in London.
This is a high-impact role focused on biosimilarity assessment, analytical strategy, and advanced molecule characterisation, working closely with cross-functional teams to support development and regulatory activities. The position offers significant visibility and the opportunity to help shape scientific capability within a growing R&D environment.
Please note, this position is 5 days on-site (non-negotiable). Visa sponsorship may be available for exceptional candidates based in the EU.
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Key Responsibilities
- Lead analytical development activities for biosimilar mAb programmes.
- Drive biosimilarity and analytical similarity assessment strategies.
- Provide technical oversight of HPLC methods including CEX, SEC, Glycan, HIC and Protein A.
- Interpret LC-MS and advanced characterisation data.
- Support capillary electrophoresis techniques including cIEF and CE-SDS.
- Contribute to regulatory submissions and CMC documentation.
- Act as a subject matter expert in cross-functional project reviews.
- Mentor and develop analytical scientists.
- Identify and implement innovative analytical technologies and approaches.
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Requirements
- Strong experience in analytical development of biologics or biosimilars, ideally monoclonal antibodies.
- Expertise in analytical similarity assessment and molecule characterisation.
- Hands-on knowledge of HPLC platforms, CE techniques and mass spectrometry data interpretation.
- Experience supporting regulatory submissions and analytical CMC documentation.
- Proven ability to provide technical leadership and mentor scientific teams.
- Strong understanding of PTMs, impurity profiling and analytical method development.
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