Gene Therapy QC Validation Specialist — Method Transfer

MeiraGTx; Greater London; On-site; GBP 55,000 - 75,000; Full time

Job summary

MeiraGTx in London is seeking a QC Validation Specialist to lead validation and tech transfer of analytical methods for gene therapy products. You will generate protocols, validate methods, and ensure documentation supports GMP and GDP compliance across sites.

Candidates should have 2+ years in a regulated pharma setting and familiarity with qPCR, HPLC, ELISA, and DNA extraction. A degree in life sciences is required, with MS preferred.

Qualifications

• Degree or Master’s in life sciences or equivalent in a regulated industry.
• Experience in analytical methods validation and method transfer.
• Familiarity with qPCR, HPLC (RP-HPLC/SEC), ELISA, Western blot and DNA extraction is preferred.
• Proficiency in ICH Q2(R1) guidelines and data integrity requirements.

Responsibilities

• Validate and transfer analytical test methods for gene therapy products.
• Generate validation protocols, data analysis and validation reports.
• Ensure methods are validated and transferred to QC GMP labs with regulatory compliance.
• Develop and implement SOPs; ensure documents are current.
• Communicate method transfer progress and maintain stakeholder information folders.
• Maintain QMS and data integrity; manage GMP/GDP compliance.

Skills

Problem solving

Cost consciousness

Motivation

Planning & organizing

Professionalism

Quality management

Oral communication

Written communication

Education

Degree/Master's in life sciences

Tools

Microsoft Office

Job description

MeiraGTx in London is seeking a QC Validation Specialist to lead validation and tech transfer of analytical methods for gene therapy products. You will generate protocols, validate methods, and ensure documentation supports GMP and GDP compliance across sites.

Candidates should have 2+ years in a regulated pharma setting and familiarity with qPCR, HPLC, ELISA, and DNA extraction. A degree in life sciences is required, with MS preferred.