BioTalent
Analytical Development - Group Leader - Biosimilars/mAbs - UK Visa Support Available
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Analytical Development - Group Leader - Biosimilars/mAbs - UK Visa Support Available
ANALYTICAL DEVELOPMENT GROUP LEADER Biosimilar mAb Characterisation Strategy London | On-site | Monday - Friday Visa Support Available: International Applicants Encouraged to Apply ──────────────────────────────────── 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
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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.
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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.
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