Director of Product Development – Personal Genome Diagnostics, Inc. – Baltimore, MD

Job Description:
We are currently seeking an extraordinary, highly motivated individual to join our research and development team, with a focus on tissue and cell-free DNA liquid biopsy approaches. The successful candidate will lead the development and optimization of cutting-edge diagnostic technologies for use as an IVD. Candidate should have a background in developing Class II or Class III assays, with design control and product development process experience.

Qualifications
PhD Degree in Biology or Related Field with a minimum of 6-8 years’ experience in molecular diagnostics or medical device industryExperience in 510k, PMA submissions, and FDA interactions requiredDesign control expertise requiredExpert knowledge of scientific principles and conceptsOncology and/or diagnostics experience strongly preferredExperience with next-generation sequencing technology and bioinformatics analyses of cancer strongly preferredExperience supervising or managing research teams

Requeriments :

• M.Sc. or higher Degree in Bioinformatics
• M.Sc. or higher Degree in Computer Science

Skills :

• Bioinformatics
• Biology

Areas :

• Bioinformatics

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