Scientist I

6 days 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 ensuring the continued compliance of our products to regulatory requirements.

Key Responsibilities
  • 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 and 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.
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 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.
  • Ability to summarize own work and effectively communicate results to colleagues.

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