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Nanobiosym · 3 months ago

Senior Scientist: IVD Assay Developer

Cambridge,MA,US

Full-time

Onsite

Senior Level

7+ years exp

Nanobiosym is an innovative nanotechnology company in Cambridge, MA, developing novel technologies to address a broad range of diseases. They are seeking a Senior Scientist to lead molecular diagnostic assay development, manage regulatory documents, and ensure compliance with FDA submission processes.

GeneticsNanotechnology

Comp. & Benefits

H1B Sponsor Likely

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

IVD assay developmentQPCRRegulatory requirementsMolecular BiologyQuality systemsProject managementLeadership expertiseCommunication skillsOrganizational skillsSelf-motivated

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

Nanobiosym

Where little things make a big difference

Founded in 2004

Cambridge, Massachusetts, USA

11-50 employees

http://nanobiosym.com/

H1B Sponsorship

Nanobiosym has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (1)

2022 (1)