Associate Director of Product Development
RTP, North Carolina
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.
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.
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
To apply, please email your CV and cover letter to email@example.com.
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