Overview
Analytical Consultant - Method Validation & Protein Characterisation (Biologics)
6 month contract
UK or EU Based - 100% Home/Remote based
£100 - £120 per hour
Immediate Start
Our client is an established biopharmaceutical organisation who is seeking an experienced Analytical Consultant to support a high priority programme focused on method validation, protein characterisation, and enzyme analytics.
This is a hands on, senior level contract role suited to an expert who can step in quickly, take ownership of complex analytical workstreams, and operate confidently in a regulated biologics environment.
The Role
You will play a key role in the development, validation, and lifecycle management of analytical methods supporting biologic drug substance and drug product. The focus is on size variants, charge variants, and enzyme activity, with strong exposure to comparability, specifications, and regulatory interactions.
Key Responsibilities
- Hands on development, validation, and troubleshooting of physicochemical and functional assays including SEC?HPLC, cIEF, and enzyme activity / kinetics assays
- Investigation and resolution of assay variability (aggregation, charge variants, activity drift)
- Support comparability assessments between drug substance and drug product and/or across analytical sites
- Contribution to CQA definition, specification setting, and analytical control strategies
- Preparation and defence of analytical approaches supporting regulatory submissions and agency interactions (e.g. FDA)
- Determination of re-validation versus risk based reassessment within the analytical lifecycle.
- Collaboration with internal stakeholders and external CDMOs
Required Experience
- Significant hands-on experience in analytical development and method validation for biologics
- Strong background in protein characterisation and enzyme-based assays
- Demonstrated expertise with SEC?HPLC and cIEF
- Experience supporting IND/BLA-stage programmes
- Ability to operate autonomously in a consultant or senior expert capacity
Highly Desirable
- CDMO experience
- Multi-site analytical comparability exposure
- Experience mentoring or leading analytical teams
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