Senior Product Development Scientist
Biofidelity’s mission is to improve and extend cancer patients’ lives by enabling better targeting of therapies, early detection of treatment resistance, and routine monitoring of treatment response. Our unique technology is designed to allow rapid, broad adoption of our assays in testing labs around the world, enabling a step change in patient care.
At Biofidelity we are proud to have built a culture of teamwork, openness and trust. We work towards well-defined goals, with a strong belief that we can bring real benefits to patients. Our people are keen to take responsibility for their work and share both their successes and challenges.
Alongside a competitive salary, we offer a comprehensive benefits package including private medical care, share option scheme, pension, cycle to work scheme, 26 days per year holiday allowance and free physical training sessions.
The role
Biofidelity is expanding its Product Development team responsible for the development of molecular diagnostic assays based on its core technology. We are seeking an experienced senior scientist or principal scientist to help us build and validate our product. This role will be primarily laboratory-based with a strong emphasis on IVD product development.
Key responsibilities:
Independent development and iterative experimentation to drive improvement of assays for clinical diagnostic testing
Validation of novel assays and reagents for clinical diagnostic testing
Independent analysis and interpretation of data and results, drawing out of conclusions and strategic recommendations
Interaction with team members in a multidisciplinary environment to ensure communication of project-relevant progress
Development and validation of QC assays for reagents
Writing SOPs, reports and safety documentation
Giving advice and training others to perform validated assays
Detailed data recording under ISO 13485 standard
Presenting results to the team
Knowledge, Skills and Abilities:
Strong background in molecular biology (essential)
Experience in biotechnology method development (preferred)
Experience with assay optimisation and validation (essential)
Familiar with IVD regulatory requirements (preferred)
Highly motivated, team-oriented individual with strong attention to detail (essential)
Can-do attitude to problem-solving using novel approaches (essential)
Experience in the following areas:
o Molecular diagnostic assay development & optimisation (essential)
o Diagnostic validation and verification trials (essential)
o Writing of SOPs & IFUs (preferred)
o Quality management systems (preferred)
o Reagent manufacturing & quality control (preferred)
Requisite Education and Experience / Minimum Qualifications:
Proven industry experience in the development, optimisation and validation of clinical diagnostic assays
PhD in a relevant subject with preference for molecular biology and oncology (preferred)
Previous experience in working under ISO 13485, or similar (ISO17025, GLP, GCP and GMP), is an advantage
To apply, please email your CV and cover letter to careers@biofidelity.com
How to apply
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