Assay Development Scientist - Gainesville, FL (on-site)
The successful Assay Development Scientist will lead diagnostic assay development in a hands-on manner while ensuring regulatory compliance, allowing 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 by the organization.
- Provide hands-on leadership in the development of diagnostic assays, including the production of protocols and reports for formal validation and verification.
- Create and run tests to verify that biosensors adhere to the exacting quality and precision criteria set by the business.
- Create performance guidelines for assays and execute technical troubleshooting.
- Contribute to regulatory documentation.
- Manage dynamic timelines and procedures for all aspects of product development, particularly for bioengineering, genome sequencing, and cDNA hybridization.
- Support the planning and preparation of regulatory submissions for product approvals and clearances necessary by regulatory and/or governmental authorities. Assist in the company's technical communications.
- Assist in organizing meetings and communications with outside partners to make sure that output meets accuracy and quality standards.
- Take part in cross-functional product development, manufacturing, quality, and regulatory teams to make sure the company is prepared to fulfill schedules, goals, and objectives for product development. collaborate with business partners to speed up product development.
- Keep laboratory records and practices up to date and compliant, and proactively enhance the efficacy, efficiency, and quality of R&D initiatives.
- Support all applicable laws, such as the FDA, ISO, IVDR, MDCG, and CMDCAS requirements.
- As needed, assess other quality system documents for approval and support the quality management system.
- Create the technical procedures required to execute technical processes consistently and guarantee ongoing compliance.
Experience & Education:
- B.S. or higher degree in Molecular biology or a closely related field.
- 10+ years experience of biotechnology research and development with an advanced degree (preferred)
- 5+ years of relevant industry experience and IVD assay development
- Experience working in laboratories with a BSL-2 classification is preferred.
- GLP requirements, FDA regulations, vendor-sponsor best practices, strong technical skills, and is capable of supporting infrastructure assessment and improvement.
- Experience with molecular assay development for device applications, including design of experiments and optimization of molecular interactions with nanomaterials, particularly allotropes of carbon and polymers.
- Deep knowledge and hands on experience with qPCR, sequencing and standard molecular biology techniques.