Tech Stack

Description

You will lead a multi-functional team of scientists responsible for developing and validating clinical diagnostic assays from concept through launch. Your role involves overseeing assay development for new assays and product extensions, including expanding the clonoSEQ MRD franchise to additional diseases, sample types, and analytes. You will collaborate with cross-functional teams and represent Clinical Product Development on project core teams to drive product development processes.

Requirements

• PhD in molecular genetics, immunology, bioengineering, or related field with 8+ years of experience
• 4+ years of experience in a diagnostic, medical device or life sciences company
• 4+ years of supervisory experience
• Deep understanding of molecular biology, genomics, multiplex PCR, NGS technology, sequencing data analysis and statistical analysis
• Experience developing IVD or CLIA assays under design control

Responsibilities

• Lead clinical assay development and validation activities
• Provide scientific leadership and decision-making for the team
• Collaborate with cross-functional project core teams
• Oversee design control activities and risk management documentation
• Implement development best practices and mentor team members