Senior Scientist - Analytical Method Validation

Organization: 
23andMe
Job Location: 
Mountain View, CA
Salary: 
Competitive package and free genotyping for you and a friend!
Benefits: 

Benefits, stock options, and CalTrain Go Pass!

Job Description: 

23andMe is pushing the envelope for low cost and high accuracy genetic testing. We are looking for experienced scientists who are excited by the opportunity to demonstrate the accuracy of our tests, both current and future. 



This position will:
- Design studies to validate the accuracy of new genotyping/sequencing technologies against existing gold standards
- Perform statistical regression modeling to establish equivalence and explain variance in observed data
- Investigate, explain, and propose solutions for observed discordances
- Develop and track project plans and generate detailed records and documentation for our quality system and regulatory submission.
- Coordinate with lab team and organizations to obtain relevant reference data and samples
- Participate in ongoing regulatory efforts, both domestic and international

Requirements: 

The ideal candidate should have:
- a PhD in biology, chemistry, statistics or related discipline
- 2+ years experience with developing in-vitro diagnostic devices used in a clinical setting
- familiarity with genetic testing technologies such as microarrays, Sanger sequencing, and Next Generation sequencing
- experience preparing and submitting to FDA (eg. 510(k), PMA) and international (eg. CE Mark) a strong plus

Contact Information: 
About Our Organization: 

23andMe is the leading personal genetics company. We are dedicated to helping individuals understand their own genetic information through DNA analysis technologies and web-based interactive tools. Our mission is to personalize healthcare by making and supporting meaningful discoveries through genetic research. Combining web development, computer science, genetics, social media, and informatics, 23andMe is at the forefront of a new era in personal genetics.