Quality Control 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

Join the forefront of biotechnology and ensure the quality, accuracy, and compliance behind next-generation gene therapy products.

R&D Partners is seeking a Quality Control Validation Analyst to join a leading biotechnology company.

The Quality ControlValidation Analyst is responsible for the validation, qualification, and transfer of both new and existing analytical test methods used to assess advanced biological products and related manufacturing materials. The role supports GMP-compliant laboratory operations and ensures testing activities meet applicable regulatory requirements and quality standards for commercial and clinical manufacturing.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Develop, validate, and transfer analytical test methods for existing and emerging 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, ensuring timely communication of method transfer progress.
• Conduct routine performance assessments of analytical methods and support Quality Management System activities.
• Complete training documentation and GMP actions (e.g., CAPAs, change controls, audit responses) within required timelines.

Key Skills and Requirements:

• 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.
• Preferably experienced with qPCR, HPLC (RP-HPLC, SEC), ELISA, SDS-Western blot, cell culture, and DNA extraction.
• Knowledge of ICH Q2(R1) guidelines.

For more information, please contact Jessica Taylor.