What are the responsibilities and job description for the Senior Scientist : IVD Assay Developer position at Nanobiosym?

Job Description

Nanobiosym is an innovative nanotechnology company in Cambridge, MA, developing novel technologies to address a broad range of diseases. Nanobiosym was founded by an MIT / Harvard alum to work at the interface of physics, nanotechnology, and biomedicine. Nanobiosym was awarded the 2013 X-PRIZE- the first X-PRIZE ever awarded for healthcare.

DUTIES

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

QUALIFICATIONS

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

Prefer commercial assay experience

Demonstrated experience and understanding of quality systems (e.g., GLP, ISO, etc.)

Prefer experience working in BSL-2 laboratory facilities

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

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Senior Scientist : IVD Assay Developer

What are the responsibilities and job description for the Senior Scientist : IVD Assay Developer position at Nanobiosym?

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