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Senior/Laboratory Research Scientist
2 months ago
Senior Scientist (Product Maintenance) Reports to: Product Maintenance Team Leader
Manchester Science Park
Contract Type: Full-time, Permanent
Salary & Benefits: Competitive Salary + Benefits Package
The group works in partnership with global leaders in DNA technology to advance diagnostic science.
The Group's flagship in vitro diagnostic products include non -invasive prenatal tests (NIPT) for Down's Syndrome and other genetic disorders, Cystic Fibrosis screening tests, invasive rapid aneuploidy tests and DPYD genotyping.
Yourgene also has a global laboratory service network equipped to be a full life-cycle partner for clinical, research and pharmaceutical organisations to support partners at the preclinical, clinical, and post market stage to develop, manufacture, obtain regulatory approval and commercialise new products and services. In addition, Yourgene offers and NIPT and high throughput Covid testing service.
Yourgene Health is headquartered in Manchester, UK with facilities in Taipei, Singapore, the US and Canada.
We have nay social and well-being initiatives run by our Social Huddle that keep our sense of community alive during challenging times that the pandemic has thrown our way. Yourgene Health, part of Novacyt Group are recruiting for a Senior Scientist within our Product Maintenance team based at Manchester Science Park. The Senior Scientist will lead the delivery of the product maintenance team’s objectives through a combination of in-depth product knowledge, excellent scientific skills and regulatory/documentation expertise.
The Senior Scientist will be an expert in molecular diagnostics with in-depth knowledge of Yourgene products and the associated regulatory landscape and requirements. They will provide scientific and technical leadership, with a system level approach, to product maintenance projects. Provide scientific and technical leadership on projects, as well as planning the delivery of Product Maintenance projects.
Lead and participate in complex projects requiring cross functional collaboration.
Support the resource planning activities of the Product Maintenance Team leader and other Team and Project Leaders as required.
Product technical files and risk files to meet regulatory requirements.
Developing, planning and implementing protocols to show that tests meet performance and regulatory requirements.
The generation and organization of high volumes of data, ensuring that data integrity and traceability is maintained.
Provide accurate, concise and independent data interpretation, factoring in systems-level thinking.
Provide advice to other project teams in the planning and execution of validation and verification studies.
Ensure own work meets regulatory & quality requirements, including compliance to SOPs, documentation using lab books, study plans, study reports and integrity of data.
First and/or higher degree (or equivalent) in a life science such as molecular biology, biochemistry or genetics.
~Excellent knowledge of regulatory requirements for in-vitro diagnostics and implementing efficient and effective studies to ensure compliance.
~ Excellent data analysis, interpretation and reporting skills.
~ Experienced in the preparation and maintenance of product risk management files to meet ISO14971.
~ Enthusiasm, drive, thoroughness, diligence and a willingness to take personal responsibility to ensure that projects are successful.
~ Can summarize complex scientific data to effectively communicate plans, progress and ideas with Management, Peers or External Audiences.
Sunday 15th September, 2024
Yourgene Health is committed to encouraging equality, diversity and inclusion among our workforce.
