Fulltime opportunity within Genetics testing group.

This is an opportunity for a highly motivated scientist to work in a fast-paced environment and develop diagnostics at the cutting edge of technology and medicine. The successful candidate will incorporate IVD and molecular biology experience to develop robust and innovative diagnostics that make an impact on world health. This position will be an integral part of advancing genetic analysis in the clinical market.

Job responsibilities include:

• Participates in IVD development, from proof of concept to validation, regulatory submission and launch
• This is a hands-on bench scientist position that involves both proof of concept testing and rigorous validation
• Collaborates across functions, eg. software, product mgmt., QARA etc.
• Ensures products are adequately developed to enable smooth Design Transfer
• Actively participates as a member of cross-functional product development teams
• Performs high-quality science and data-driven decision making, with a foundation in statistical analysis, DOE, and six sigma methods
• Ensures DHFs and technical files meet applicable standards. Documentation under design control to ensure quality product development.
• Drives continuous process improvement
• Ensures projects meet timelines; identifies and removes roadblocks to team success

Experience required:

• PhD in Molecular Biology / Genetics / Biochemistry / Bioengineering and minimum 1 year experience in biotech; M.S. with 4+ years of relevant assay development experience.
• Demonstrated teamwork under tight timelines
• Extremely organized and driven to complete projects efficiently
• Completes studies independently and with technical rigor
• Commercial qPCR assay development experience is highly desirable
• Strong experience working in a regulated environment OR demonstrated attention to detail.
• Experience in Design Control a plus
• Expertise in Process Capability / Six Sigma using JMP analysis a plus
• Demonstrates a passion for problem-solving and outside-the-box thinking
• Strong written communication and verbal presentation skills are essential
• Must be highly collaborative; enjoys working in a diverse team and contributes to a positive work environment
• Self-motivated, independent, proactive, organized, diligent, and very nimble