Associate Director of Product Development

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. 

The role

Biofidelity is seeking a highly motivated and adaptable Associate Director of Product Development to lead the development and life-cycle management of new testing services. Reporting to the Director of Operations (CLIA/CAP), the role will be responsible for successfully translating R&D into robust, efficient and high quality clinical diagnostics products. The ideal candidate will be comfortable working in a cross-functional team, which integrates R&D, clinical operations, software, program management, manufacturing and regulatory, and has a high level of understanding of both molecular biology and clinical laboratory operations.

Key responsibilities:

• Translating R&D into robust, efficient and high quality clinical laboratory assays that can be run at scale

• Planning and executing analytical validation studies to appropriate regulatory standards

• Developing SOPs and training materials for product development, manufacturing, operations, supplier and vendor management, and the clinical lab as required

• Supporting clinical laboratory operations including training, proficiency testing, preparation and qualification of reagents, and hands-on processing of clinical samples

• Working closely with IT to ensure integration of laboratory and informatic processes, including sample traceability and reporting

• Working to continuously improve laboratory operations

Knowledge, Skills and Abilities:

• High level of technical understanding of molecular biology

• Experience of verification and validation experiments

• Understanding and experience of clinical lab procedures

• Knowledge and experience of next-generation sequencing

• Excellent analytical skills and attention to detail

• Strong communication skills with the ability to summarize complex information and successfully interact with different audiences

Requisite Education and Experience / Minimum Qualifications:

• A degree in the relevant field 

• Prior experience of working in a CLIA/CAP certified laboratory or diagnostics laboratory in a regulated environment