Senior Scientist (Product Maintenance)

at  Yourgene Health

Job Advert
Job title: Senior Scientist (Product Maintenance)
Reports to: Product Maintenance Team Leader
Location: Manchester Science Park
Contract Type: Full-time, Permanent
Salary & Benefits: Competitive Salary + Benefits Package
About Yourgene Health:
Yourgene Health is a leading integrated technologies and services business, enabling the delivery of genomic medicine. The group works in partnership with global leaders in DNA technology to advance diagnostic science.
Yourgene primarily develops, manufactures, and commercialises simple and accurate molecular diagnostic solutions, for reproductive health, precision medicine and infectious diseases. 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 has a range of innovative DNA sample preparation platforms, powered by Ranger® Technology, the Yourgene LightBench® and Yourgene QS250, ideal for cell free DNA applications in NIPT and oncology including liquid biopsy.
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.
Our Culture:
Yourgene is a growing, vibrant and exciting place to work, we are looking for committed driven individuals to be part of our next growth journey. Our culture is described by our employee’s as collegiate, friendly, professional, innovative, open and fast paced. 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. At Yourgene we focus on putting values led programmes in place to ensure that we can attract, retain and develop our people. We want our people to have a career with Yourgene and we ensure that they are recognised and rewarded for their achievements and commitment, everyone plays a critical role in our growth journey.
Description of role:
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.
Overall responsibility:
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. The Senior Scientist will plan and lead work packages in conjunction with the Product Maintenance Team Leader, taking an active role in experimentation and documentation and working collaboratively with the wider R&D teams. The Senior Scientist will ensure work is performed efficiently and to a high standard.ms.

Key areas of responsibility:

• 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.
• Lead the authoring of QMS documentation including the creation, maintenance and improvement of;
• Product technical files and risk files to meet regulatory requirements.
• SOP’s.
• Work package plans & reports.
• Design effective and efficient work packages and studies involving;
• Developing, planning and implementing protocols to show that tests meet performance and regulatory requirements.
• Ensuring that experimental design and execution is robust, meets the intended aims and facilitates clear decision making and reporting.
• 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.
• Accurate, efficient and timely preparation and review of documentation.
• Presentation and dissemination of results to the wider R&D team, Yourgene Health and external parties, as required.
• Lead troubleshooting activities when technical issues arise.
• Maintain up to date knowledge, including any upcoming changes, of relevant clinical guidelines/recommendations e.g. IVDR or FDA, to ensure products remain in compliance.
• Provide advice to other project teams in the planning and execution of validation and verification studies.
• Participate in post market surveillance activities.
• Establish and develop external relationships, including through for example, grant applications, KOLs, consultants and partners.
• Ensure own work meets regulatory & quality requirements, including compliance to SOPs, documentation using lab books, study plans, study reports and integrity of data.
• Ensure own work and that of junior staff is performed in line with company goals.
• Support and provide guidance to junior staff.

Qualifications, Skills and Abilities:

• First and/or higher degree (or equivalent) in a life science such as molecular biology, biochemistry or genetics.
• 7+ years of relevant industry experience, including working in an ISO13485 environment.
• Excellent knowledge of regulatory requirements for in-vitro diagnostics and implementing efficient and effective studies to ensure compliance.
• Expertise and experience in the development, verification and validation of molecular in-vitro diagnostic assays.
• Excellent documentation skills.
• Excellent data analysis, interpretation and reporting skills.
• Experienced in the preparation and maintenance of product risk management files to meet ISO14971.
• Deep knowledge of experimental design and execution with the ability to lead and train others.
• 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.

Closing Date:
Sunday 15th September, 2024
Yourgene Health is committed to encouraging equality, diversity and inclusion among our workforce. The aim is for our workforce to be truly representative of all sections of society and for each employee to feel respected and able to give their best

Please refer the Job description for details