assay development efforts for the company's commercialization, and FDA 510(k) submission, initiatives Adhere to Good Laboratory Practice (GLP) guidelines in 21 CFR Part 58 (FDA, DHHS) relevant to Client's laboratory activities. Adhere to Client's design control, Good Documentation Practice (GDP) and quality system procedures Support stability protocols, plans and actions Support development of BOM and assay design transfer activities Work with general molecular biology laboratory equipment, biological specimens, reagents and chemicals Maintain a safe, organized, and efficient work area following laboratory SOPs.
Design and execute experiments and test protocols according to study/test
plans Troubleshoot and investigate failures related to assay reagents and other consumables Analyze experimental data and write study reports Required Skills Bachelor's degree in Biomedical sciences, Medical Technology, or related technical field, or equivalent years of education and experience required At least 1 year of experience in IVD assay development and commercialization required.
Experience in molecular diagnostic assay development preferred. Hands-on experience in DNA, RNA, PCR and general molecular biology laboratory techniques Experience with working in BSL2 laboratory is preferred Basic knowledge in statistical methods is preferred Ability to write scientific and/or
technical documents, such as experiment plans, protocols and reports Ability to properly operate laboratory tools and equipment including pipettes, centrifuges, vortex mixers, incubators, PCR enclosures, biosafety cabinet, refrigerators and freezers Ability to perform repetitive testing with a high level of attention to detail General computer experience and ability to use corporate data/document/project systems and operate/monitor test equipment.
Applicable knowledge of Microsoft Office (including Excel). Effective verbal and written communication with team members, scientists, engineers, and project managers.
