Scientist I

About Nuclein:

Nuclein is an Austin-based, private equity funded, medical device company that offers an innovative, FDA EUA authorized, rapid PCR, point-of-care system. The Nuclein DASH™ Rapid PCR System is easy-to-use, affordable, and provides PCR results in only 15 minutes.

Our vision is to enable simple, affordable, rapid and accurate testing for everyone. We are a dedicated, talented and diverse team of scientists, engineers and experienced professionals who are driven to excel and make a significant contribution to the world. At Nuclein, we offer a fast-paced, exciting, collaborative environment where individual contributions are highly valued as we work to expand the use of our transformative testing technology in the market.

Please visit Nuclein.com for more information about our company's history, technology, and vision.

Position Summary:

The Scientist 1 position will work as part of the Nuclein Assay Development organization, reporting to the Assay Development Manager. The individual will work within design control and scientific methods to design and perform experiments and tests necessary for the development, commercialization and support of assay products and related products.  

Responsibilities:

• Support the 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 Nuclein’s laboratory activities.
• Adhere to Nuclein’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
  

Qualifications:

• 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.