Senior Scientist, Molecular BiologyCambridge, UK
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 humanity, openness and high expectations. 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 with several opportunities for career development, we offer a comprehensive benefits package including private medical care, bonus, share option scheme, pension, cycle to work scheme, 26 days per year holiday allowance and free physical training sessions.
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 to help us build and validate our product. This role will be primarily laboratory-based with a strong emphasis on IVD product development.
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
Leading projects involving additional team members
Supervising and training responsibility for more junior members of the team
Potential line management responsibility
Knowledge, Skills and Abilities:
Strong background in molecular biology (essential)
Experience with assay optimisation and validation (essential)
Highly motivated, team-oriented individual with strong attention to detail (essential)
Demonstrate strong relationship building with colleagues across the organisation
Ability to multi-task and problem-solve using novel approaches with a positive approach
Experience in biotechnology method development (preferred)
Familiar with IVD regulatory requirements (preferred)
Experience in the following areas:
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 experience in the development, optimisation and validation of clinical diagnostic assays
PhD in a relevant subject with preference for molecular biology and oncology plus more than 5 years of relevant academic or industrial experience
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 email@example.com
For informal enquiries about the post, please contact Ana Kukic, Operations/HR Manager, firstname.lastname@example.org.
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