QC Validation Specialist
Location:
UK & Ireland
Blackfield Associates are partnering with a leading biopharmaceutical organisation to recruit a
QC Validation Specialist,
to join the team on a permanent basis from either their London or Ireland office. This role offers the chance to support the validation and transfer of analytical methods for cutting-edge gene therapy products within a GMP-regulated environment.
Key Responsibilities
* Develop, validate, and transfer analytical methods.
* Prepare validation protocols, reports, and SOPs in line with GMP and regulatory standards.
* Support technology transfer and ensure compliance with EU/FDA guidelines.
* Apply a range of analytical techniques (e.g. qPCR, HPLC, ELISA, Western blot, cell culture).
About You
* Degree or MSc in Life Sciences or related field.
* 2+ years' experience in pharma/biologics or other regulated industry.
* Strong background in analytical methods/validation, HPLC experience is a non-negotiable.
* Knowledge of ICH Q2(R1), GMP, GDP, and data integrity.