Senior Scientist: IVD Assay Developer
Cambridge, MAFull-time$80–130K/yrPosted 7mo agoSeen in employer's feed 3 days ago
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Job overview
Nanobiosym, Inc. is hiring a Senior Scientist: IVD Assay Developer. Nanobiosym, Inc. is an innovative nanotechnology company in Cambridge, MA, developing novel technologies to address a broad range of diseases. Founded by an MIT/Harvard alum, the company works at the interface of physics, nanotechnology, and biomedicine. Nanobiosym was awarded the 2013 X-PRIZE for healthcare.
Key focus areas include Lead molecular diagnostic assay development through successful FDA submission, Manage and contribute to regulatory documents, and Project management.
Successful candidates bring PhD In Nucleic Acids Biochemistry and 7+ Years Relevant Industry Experience. Important skills include Molecular Diagnostic Assay Development, Regulatory Document Management, Assay Performance Specifications Design, Technical Troubleshooting, Compliant Laboratory Document Maintenance, and R&D Efficiency Improvement. Preferred (not required): Personnel Management and BSL-2 Laboratory Experience.
Skills & qualifications
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Full job description
Cambridge, MA, USA | 80000-130000 per year | Full Time
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
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Lead molecular diagnostic assay development in a hands-on manner through successful FDA submission
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Manage and contribute to regulatory documents
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Project management; personnel management skills preferred
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Design assay performance specifications
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Ensure assay development process meets milestones and timelines
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Troubleshoot and solve technical issues
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Maintain compliant laboratory documents and procedures
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Pro-actively improve efficiency, quality and effectiveness of R & D efforts
QUALIFICATIONS
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PhD in Nucleic Acids Biochemistry, Molecular Biology, or related field
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Minimum of 7 years of relevant industry experience and IVD assay development
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In depth knowledge and hands on experience with qPCR, sequencing and standard molecular biology techniques
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Demonstrated technical, managerial and leadership expertise in assay development
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Strong understanding of FDA and global regulatory requirements
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Prefer commercial assay experience
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Demonstrated experience and understanding of quality systems (e.g., GLP, ISO, etc.)
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Prefer experience working in BSL-2 laboratory facilities
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Strong work ethic and ability to generate high quality work under tight deadlines
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Flexibility in work schedule
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Self-motivated, independent and a driving force of efficient execution
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Strong organizational and project management skills
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Excellent oral and written communication skills
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