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Gene Therapy Validation Expert
1 month ago
We are seeking an ambitious and driven Gene Therapy Validation Expert to lead the development, validation, and lifecycle management of critical test methods for groundbreaking gene therapy products at S3 Science.
About the Role:This is a key position within our team, requiring strong leadership skills and experience in managing teams. The successful candidate will have extensive experience in the validation of analytical methods within the pharmaceutical or regulated industry, with a solid understanding of ATMPs and GMP regulations.
Key Responsibilities:- Lifecycle Management: Oversee the complete lifecycle management of assays, equipment, materials, and in-process samples, ensuring optimal performance and compliance throughout.
- Project Management: Be responsible for the implementation of test methods within defined timelines, enabling the seamless launch of new gene therapies.
- Compliance Champion: Ensure all methods are compliant with EU and FDA GMP regulations, maintaining data integrity and supporting regulatory submissions.
- External Testing Oversight: Manage and coordinate external testing activities, ensuring they align with internal quality standards and meet GMP requirements.
- Documentation Excellence: Generate and manage qualification/validation documentation, ensuring all analytical activities are well-documented and compliant with regulatory and internal standards.
- Cross-Functional Collaboration: Communicate effectively with stakeholders across departments, ensuring transparency and timely updates on projects.
- Training & Development: Lead the rollout of training for new technologies and methods, empowering your team to stay ahead of the curve in gene therapy advancements.
To be successful in this role, you should have a degree in Human Health or Sciences, with extensive experience in the pharmaceutical or other highly regulated industries like biologics. Proven experience in a QC Validation role with a strong track record of successfully managing teams and delivering high-impact projects is essential.
A deep understanding of regulatory compliance, including GMP, EU and FDA requirements, and data integrity standards is required. You should also be willing to travel between our UK and Ireland sites as required.
What We Offer:We offer a competitive salary of £65,000 - £85,000 per annum, depending on experience, as well as opportunities for continuous learning and development. Our state-of-the-art manufacturing and testing facilities are designed to meet the highest global regulatory standards, giving you the tools and environment you need to succeed.
You will be part of a dynamic, forward-thinking team that embraces innovation and empowers you to make a real difference in people's lives. If you're ready to take your career to the next level and contribute to life-changing science, we want to hear from you.