Biotech Gene Therapy QC Validation Analyst

R&D Partners; Greater London; On-site; GBP 40,000 - 60,000; Full time

Job summary

R&D Partners is seeking a Quality Control Validation Analyst to join a leading biotechnology company. The role focuses on validation, qualification, and transfer of analytical test methods used to assess gene therapy products, with GMP-compliant laboratory operations.

Please note the right to work in the United Kingdom is required. Jessica Taylor will be the contact for further information.

Qualifications

• Degree or Master’s in a scientific or health-related discipline.
• Minimum of 2 years of experience in a pharmaceutical or similarly regulated environment.
• Hands-on experience in analytical method validation within research or GMP settings.

Responsibilities

• Develop, validate, and transfer analytical test methods for gene therapy products.
• Prepare validation protocols, analyze data, and generate reports to support method lifecycle activities.
• Ensure analytical methods comply with GMP regulatory guidelines and data integrity principles.
• Create, update, and maintain method-related SOPs, communicating progress on method transfers.
• Conduct routine performance assessments of analytical methods and support Quality Management System activities.
• Complete training documentation and GMP actions (CAPAs, change controls, audit responses) within required timelines.

Skills

Analytical method validation

qPCR

HPLC

ELISA

SDS-Western blot

Cell culture

DNA extraction

Education

Master's or Bachelor's in a scientific/health-related discipline

Job description

R&D Partners is seeking a Quality Control Validation Analyst to join a leading biotechnology company. The role focuses on validation, qualification, and transfer of analytical test methods used to assess gene therapy products, with GMP-compliant laboratory operations.

Please note the right to work in the United Kingdom is required. Jessica Taylor will be the contact for further information.