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Scientist I
2 months ago
Job title: Scientist I (Product Maintenance)
Have you got what it takes to succeed The following information should be read carefully by all candidates.
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 Scientist I within our Product Maintenance team based at Manchester Science Park. The Scientist I will support the delivery of the product maintenance team’s objectives through the execution of high quality and efficient experimental work and assisting in the preparation and review of documentation for the continued compliance of products to regulatory requirements.
Overall responsibility:
The Scientist I will be skilled in the laboratory testing of molecular diagnostics, specifically of Yourgene products. They will have the desire to learn about the associated regulatory landscape and requirements. The Scientist I will work closely with the Senior Scientist and Team Leader to execute work packages, taking an active role in experimentation and documentation and working collaboratively with the wider R&D teams.
Key areas of responsibility:
- Provide scientific expertise and input into the planning and execution of laboratory work.
- Actively participate in complex projects requiring cross functional collaboration.
- Support the design of 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.
- Accurate, efficient and timely reporting of results.
- Support troubleshooting activities when technical issues arise.
- Support the authoring of QMS documentation.
- Review of relevant clinical guidelines/recommendations e.g. IVDR or FDA, to support Product Maintenance Team objectives.
- Participate in post market surveillance activities.
- Ensure own work meets regulatory & quality requirements, including compliance to SOPs, documentation using lab books, study plans, study reports and integrity of data.
- Carry out regular equipment maintenance tasks as required.
- Participate in tasks required for the maintenance of the laboratory areas e.g. stock check, ordering of reagents and consumables, laboratory cleaning
Qualifications, Skills and Abilities:
- First and/or higher degree (or equivalent) in a life science such as molecular biology, biochemistry or genetics.
- 2+ years of relevant industry experience, including working in an ISO13485 environment.
- The desire to learn about regulatory requirements for in-vitro diagnostics and implementing efficient and effective studies to ensure compliance.
- Experience in the development, verification and validation of molecular in vitro diagnostic assays.
- Experience of and confident in data analysis and interpretation.
- Experience of and confident in the preparation of experimental reports and QMS/regulatory documentation.
- Enthusiasm, drive, thoroughness, diligence and a willingness to take personal responsibility to ensure that projects are successful.
- Can summarize own work and effectively communicate results to colleagues.
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.
