Assay Development Scientist
Permanent Cambridge, 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 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 setbacks.
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.
Biofidelity is expanding its clinical assay team responsible for the development of molecular diagnostic assays based on its core technology. We are seeking experienced assay development scientists to help us build and validate these assays as we take our technology into the clinic. This role will be primarily laboratory-based.
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:
PhD plus proven industry experience in the development, optimisation and validation of clinical diagnostic assays (or equivalent extensive industry experience)
Previous experience in working under ISO 13485, or similar, is an advantage
To apply, please email your CV and cover letter to firstname.lastname@example.org
We are seeking an experienced DevOps Engineer to help develop platforms for the research, storage and display of diagnostic test data.
We are seeking a talented Bioinformatician to play a pivotal role in developing and implementing bioinformatic solutions across our product development pipeline.
We are seeking a Laboratory Medical Director to direct and supervise CLIA/CAP lab testing and performance while ensuring all aspects of relevant regulatory and accreditation requirements are met.