ANGLE is a world leading and growing liquid biopsy company that develops products for use in rare cell diagnostics that enable early, accurate identification of an individual’s condition for the prevention, treatment, and monitoring of disease.
ANGLE’s research and development facilities in Guildford, UK are looking for a Verification and Validation Scientist to join ANGLE’s Product and Technology Development team and contributes to ANGLE’s NPD process by verifying and validating products (cell-based assays as well as IVD instruments) developed by the R&D team and the Product Development team.
The job is laboratory-based working in a multi-disciplinary team. Goals and routes are agreed weekly with the supervisor, but an ability to work independently is expected.
- Hands-on laboratory bench work, primarily in the area of verifying and validating cell-based assays and RUO/IVD products in the Parsortix® product range;
- Generating appropriate verification and validation (V&V) documentation through the undertaking of pre-defined V&V studies and tasks; thereby supporting project transition through stages 4 and 5 of ANGLE’s NPD process;
- Support the development of verification and validation (V&V) documentation prior to V&V task delivery;
- Provide additional adhoc scientific and technical support to manufacturing processes, R&D programmes and projects;
- Responsible for accuracy, quality and regulatory compliance of work undertaken;
- Independently keep a current knowledge base in relevant areas of scientific and technical progress;
- Contribute to managing the day to day running of assigned V&V activities within the Quality Management System (ISO13485:2016).
Qualifications, Experience, Knowledge and Attributes:
- B.Sc. or equivalent in Life Sciences related to Cell Biology, Oncology or Molecular Biology, with at least 3 years post-graduate laboratory experience gained in verification and validation for the in vitro diagnostics industry (or an equivalent combination of experience and formal education);
- Experience working to strict quality standards such as Medical Device regulations and standards including, but not limited to, 21 CFR 820, ISO 13485, 93/42/EEC, IVD 98/79 EC, ISO14971, GMP, GLP,
- QSR. A strong understanding of the importance of accurate record keeping within a strictly controlled quality system is essential;
- Organisational skills and the ability to follow agreed procedures is essential;
- Manage and deliver production to agreed timetables and according to defined instructions;
- Strong team player with excellent communication skills, work ethic and attention to detail;
- Good report writing skills, with the ability to communicate results to technical and non technical staff;
- Due to nature of role, the requirement is for Guildford based, office hours and 5 days per week, with flexibility to work shift patterns if required (due to current COVID-19 situation and Company COVID-safe risk management obligations).
As a member of our excellent and fast-growing team you will receive opportunities for development and a competitive benefits package.
Salary estimate – £27,000 per annum
Please let us know if you require disability-related accommodation during the recruitment process so that we can work with you to meet your needs.