Product Development Scientist

Biofidelity is a revolutionary genomic technology company dedicated to unleashing the potential of genomics to transform human health and the world we live in. Our adaptive platform technology removes the noise from genomic data, providing only the information needed to make decision making less complex, faster, and more accurate. 

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 make genomics globally accessible. Our people are keen to take responsibility for their work and share both their successes and challenges. 

Alongside a competitive salary and opportunities for career development, we offer a comprehensive benefits package including medical, dental and vision coverage, 401(k), bonus, stock options, life insurance,  short-term and long-term disability income protection, 20 days per year PTO allowance and 2 floating holidays in addition to Company observed holidays.

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 to help us build and validate our product. This role will be primarily laboratory-based with a strong emphasis on IVD product development. This role reports to the Associate Director of Product Development.
 

Key responsibilities:
●      Independent development and iterative experimentation to drive improvement of assays for clinical diagnostic testing
●      Technology transfer, operationalization, and implementation of assays in a clinical laboratory
●      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