Senior Scientist: IVD Assay Developer at Nanobiosym in Cambridge, MA, USA

Responsibilities

• Lead molecular diagnostic assay development in a hands-on manner through successful FDA submission
• Manage and contribute to regulatory documents
• Project management; personnel management skills preferred
• Design assay performance specifications
• Ensure assay development process meets milestones and timelines
• Troubleshoot and solve technical issues
• Maintain compliant laboratory documents and procedures
• Pro-actively improve efficiency, quality and effectiveness of R & D efforts

Requirements

• PhD in Nucleic Acids Biochemistry, Molecular Biology, or related field
• Minimum of 7 years of relevant industry experience and IVD assay development
• In depth knowledge and hands on experience with qPCR, sequencing and standard molecular biology techniques
• Demonstrated technical, managerial and leadership expertise in assay development
• Strong understanding of FDA and global regulatory requirements
• Strong work ethic and ability to generate high quality work under tight deadlines
• Flexibility in work schedule
• Self-motivated, independent and a driving force of efficient execution
• Strong organizational and project management skills
• Excellent oral and written communication skills
• Demonstrated experience and understanding of quality systems (e.g., GLP, ISO, etc.)
• Prefer experience working in BSL-2 laboratory facilities

Skills

Required

• qPCR
• sequencing
• standard molecular biology techniques
• FDA and global regulatory requirements
• quality systems (GLP, ISO)
• oral and written communication skills
• self-motivated
• independent
• strong work ethic
• flexibility in work schedule

Preferred

• commercial assay experience
• BSL-2 laboratory facilities
• personnel management skills