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Scientist I

2 months ago

Manchester, United Kingdom Yourgene Health Full time
About the Role

We are seeking a highly skilled and motivated Scientist I to join our Product Maintenance team at Yourgene Health. As a key member of our team, you will play a critical role in supporting the delivery of our product maintenance objectives.

Key Responsibilities
  • Provide scientific expertise and input into the planning and execution of laboratory work, ensuring high-quality and efficient experimental results.
  • Actively participate in complex projects requiring cross-functional collaboration, working closely with the Senior Scientist and Team Leader to execute work packages.
  • Support the design of effective and efficient work packages and studies, developing and implementing protocols to demonstrate compliance with regulatory requirements.
  • Ensure that experimental design and execution is robust, meets the intended aims, and facilitates clear decision making and reporting.
  • Generate and organize high volumes of data, maintaining data integrity and traceability.
  • Accurately and efficiently report results, supporting troubleshooting activities when technical issues arise.
  • Support the authoring of Quality Management System (QMS) documentation, reviewing relevant clinical guidelines and recommendations to support Product Maintenance Team objectives.
  • Participate in post-market surveillance activities, ensuring own work meets regulatory and quality requirements.
  • Carry out regular equipment maintenance tasks and participate in laboratory area maintenance activities.
Requirements
  • 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 ISO 13485 environment.
  • 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 confidence in data analysis and interpretation.
  • Experience of and confidence in the preparation of experimental reports and QMS/regulatory documentation.
  • Enthusiasm, drive, thoroughness, diligence, and a willingness to take personal responsibility to ensure project success.
  • Ability to summarize own work and effectively communicate results to colleagues.