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

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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.