ANALYTICAL DEVELOPMENT GROUP LEADER
Biosimilar mAb Characterisation Strategy
London | On-site | Monday - Friday
Visa Support Available: International Applicants Encouraged to Apply
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BioTalent are partnered with a growing biopharma organisation strengthening its analytical development capability within a global biosimilars portfolio. This is not routine analytical testing. This is about building and defending a robust biosimilarity and analytical similarity strategy across monoclonal antibody programmes. The focus is deep molecule-level understanding, structural characterisation and regulatory-defensible data packages.
The Role
You will lead analytical development strategy for biosimilar mAbs, with responsibility across:
• Analytical similarity and biosimilarity assessment frameworks
• Comprehensive physiochemical characterisation of monoclonal antibodies
• Establishment and optimisation of HPLC methods including: Glycan profiling, CEX, SEC, Protein A, HIC
• Capillary electrophoresis techniques including cIEF and CESDS
• LCMS data interpretation for PTM identification and structural analysis
• Impurity profiling and degradation pathway assessment
• Method development, qualification and lifecycle management
• Statistical analysis and use of DoE in analytical method optimisation
• Support of Module 3 analytical content for IND, IMPD, BLA and MAA
• Interaction with Regulatory Affairs on EMA, MHRA and FDA queries
You will act as the analytical SME in cross-functional stage gate reviews, challenging interpretations and ensuring analytical conclusions are scientifically defensible. This role is technical leadership rather than daily wet-lab execution. You may not run assays yourself every day, but you will design the strategy, review the data and direct the technical path.
Essential Experience
• Direct biosimilars analytical development experience
• Demonstrated experience in analytical similarity and biosimilarity assessment
• Strong understanding of mAb structure, PTMs and higher-order structure
• Deep expertise across HPLC and CE platforms
• Ability to interpret LCMS data for structural differences
• Experience supporting regulatory submissions with analytical content
• Experience leading or mentoring analytical scientists
This is not suitable for:
• QC analysts focused on release testing
• Small molecule analytical chemists
• Scientists without biosimilars exposure
• Pure people managers lacking technical depth
Why Move
In biosimilars, analytical similarity is the battleground. This role owns how molecules are characterised, compared and defended. It is a high-visibility position within a growing technical site backed by global experience.