We are partnering with an innovative cell & gene therapy organisation expanding its GMP footprint, now seeking a QC Validation Specialist to support analytical method validation and transfer activities across a growing pipeline.
This is an excellent opportunity for someone with a strong analytical background to step into a high-impact role, working on both established and novel assays within a cutting‑edge therapeutic area.
The Role
As QC Validation Specialist, you will be responsible for validating and transferring analytical methods into a GMP QC environment, ensuring compliance with global regulatory expectations. You’ll play a key role in bridging development and QC, ensuring methods are robust, compliant, and ready to support manufacturing and release.
Key Responsibilities
Support the development, validation, and transfer of analytical methods for gene therapy products
Author and execute validation protocols, reports, and supporting documentation
Ensure all methods meet GMP, data integrity, and regulatory standards
Develop and maintain method SOPs for QC laboratories
Track and communicate method transfer progress to key stakeholders
Perform ongoing method performance assessments and troubleshooting
Support the Quality Management System, including document control and compliance activities
Contribute to CAPAs, change controls, and deviation management
Assist with routine QC testing where required to support production timelines
What We’re Looking For
Degree (or Master’s) in a scientific discipline (Biology, Chemistry, Biochemistry or similar)
Previous experience in designing studies for method validation activities
Hands‑on experience with analytical method validation and/or transfer
Familiarity with ICH Q2 guidelines and GMP environments
Experience with techniques such as qPCR, HPLC (RP/SEC), ELISA, Western blot, cell culture
Strong documentation and technical writing skills
Ability to work cross‑functionally and manage multiple priorities
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