Analytical Development - Group Leader - Biosimilars/mAbs
8 days ago
City of London
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 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.