CHEManager International · 2 days ago
Senior Scientist: IVD Assay Developer
Cambridge, MA
Full-time
Onsite
Senior Level
7+ years expNanobiosym is an innovative nanotechnology company in Cambridge, MA, developing novel technologies to address a broad range of diseases. The Senior Scientist will lead the molecular diagnostic assay development process, ensuring successful FDA submission and managing regulatory documents.
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
Qualification
Required
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
Demonstrated experience and understanding of quality systems (e.g., GLP, ISO, etc.)
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
Preferred
Prefer commercial assay experience
Prefer experience working in BSL-2 laboratory facilities
Project management; personnel management skills preferred
Company
CHEManager International
Wiley’s leading media brand providing first-hand information on the global chemical, life science and process industries
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase