Assay Development Scientist
As an Assay Development Scientist, you will lead diagnostic assay development in a hands-on manner through successful regulatory submission(s) which allow the Company to legally market products both domestically and internationally. Hands-on in the lab, you will be responsible for designing, planning, executing, and analyzing studies to characterize, verify, or validate assays developed at IdentifySensors Biologics.
- Lead diagnostic assay development, including writing protocols and reports for formal validation and verification, in a hands-on manner through successful regulatory submission(s).
- Design and perform experiments to ensure biosensors meet the company’s high standards for quality and precision.
- Design assay performance specifications and troubleshoot to solve technical problems.
- Contribute to regulatory documents.
- Manage dynamic timelines, and processes across the product development activities, specifically bioengineering and genome sequencing and cDNA hybridization.
- Assist in the company’s technical communications and help manage planning and preparation of regulatory submissions for product approvals and clearances required by regulatory and/or government agencies.
- Assist in coordinating meetings and interactions with external partners to ensure that deliverables meet the company’s standards of quality and precision.
- Participate in cross-functional product development, manufacturing, quality and regulatory teams to help ensure the business is positioned to meet product development timelines, goals and objectives. Interface with corporate partners to facilitate product development.
- Maintain compliant laboratory documents and procedures and proactively improve efficiency, quality and effectiveness of R&D efforts
- Maintain strong relationships with relevant professional organizations & advisors.
- Support all applicable regulations including but not limited to FDA, ISO, IVDR, MDCG, and CMDCAS requirements.
- Support the quality management system and review for approval other quality system documents as applicable.
- Performs other duties as required or assigned to enable effective functioning of the R&D department.
- Establish technical procedures necessary to consistently execute technical processes and ensure continual compliance.
- B.S. or higher degree in Molecular Biology or related discipline.
- Advanced degree is strongly preferred with 10+ years of biotechnology R&D.
- Minimum of 5 years of relevant industry experience and IVD assay development
- Molecular assay development for device applications, including design of experiments and optimization of molecular interactions with nanomaterials, particularly allotropes of carbon and polymers.
- In depth knowledge and hands on experience with qPCR, sequencing and standard molecular biology techniques
- Prefer experience working in BSL-2 laboratory facilities.
- Working knowledge of GLP requirements, FDA regulations, vendor-sponsor best practices, strong technical skills, and is capable of supporting infrastructure assessment and improvement.
- Excellent organizational, writing and verbal communication skills.
- Strong interpersonal skills and excellent project management, data analysis, time management and people skills together with a sense of urgency.
- Ability to travel, including internationally, as needed.