Senior Scientist IVD Assay Developer
Senior Scientist IVD Assay Developer
Posted on :
28-04-2025
Employer Active
1 Vacancy
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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 XPRIZE the first XPRIZE ever awarded for healthcare.
DUTIES
- Lead molecular diagnostic assay development in a handson 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
- Proactively 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 BSL2 laboratory facilities
- Strong work ethic and ability to generate high quality work under tight deadlines
- Flexibility in work schedule
- Selfmotivated independent and a driving force of efficient
- Strong organizational and project management skills
- Excellent oral and written communication skills
Required Experience:
Senior IC
Employment Type
Full-Time
Key Skills
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