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.
* 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 contentExperience 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.
#J-18808-Ljbffr