Associate Director of Product Development - Oncology
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POST DATE 9/17/2016
END DATE 10/18/2016
San Carlos, CA
JOB DESCRIPTIONDriven by the passion for elevating the science and utility of genetic testing, Natera is committed to helping families identify and manage genetic diseases. Natera is a rapidly-growing diagnostics company with proprietary bioinformatics and molecular technology for analyzing DNA. Our complex technology has been proven clinically and commercially in the prenatal testing space and we are actively researching its applications in the liquid biopsy space for developing products with oncology applications.
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you ll work hard and grow quickly. Working alongside the elite of the industry, you ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
Natera is looking for a highly motivated and experienced Associate Director of Product Development to drive the launch of cutting edge molecular diagnostic tests for oncology. The responsibilities of this position include leading highly technical laboratory teams to launch and sustain LDT and IVD products.
Leverage experience in technical product development management to quickly and successfully build complex molecular diagnostic products
Build and lead a team of scientists in support of Natera s LDT/CE/IVD product development activities; establish project timelines and resourcing plans
Provide leadership in design input/output/verification and validation according to Design Control processes
Work with commercial operations to collect and integrate customer requirements into product designs
Lead teams to optimize assay processes and chemistry, rigorously review data to arrive at sound scientific conclusions and next steps
Oversee development of technical studies and documentation needed to support product claims; write and review technical reports, design validation plans for novel assays
Enhance quality control processes associated with the developed assays, throughout their life-cycle, from the assertion of quality of new lots, through the SOPs used for the assessment of each sample running through the workflow
Work with QA/RA to ensure compliance with ISO13485, FDA/QSR and other relevant regulations
Work with operations to transfer product designs to manufacturing
Act as the interface between the Lab Technology Research group and the Clinical Lab by translating newly developed assays to robust workflows that are ready for deployment in the clinical lab