Our client is a dedicated Austin-based, private equity-funded, medical device company that offers an innovative, FDA EUA-authorized, rapid PCR, point-of-care system. Their product is easy-to-use, affordable, and provides PCR results in only 15 minutes. They have a vision to enable simple, affordable, rapid and accurate testing for everyone. They are an incredibly talented and diverse team of scientists, engineers, and experienced professionals who are driven to excel and make a significant contribution to the world.
As they continue to grow exponentially, they are looking to hire a Scientist I, who will work as part of an Assay Development organization, reporting to the Assay Development Manager. The best fit for this role 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.
What's in it for YOU?
- They offer a fast-paced, exciting, collaborative environment where individual contributions are highly valued as they work to expand the use of transformative testing technology in the market.
- A wonderful company culture with great core values and looking for team players who also align with them – Value Everyone, Ownership, Innovation, Collaboration and Excellence-driven!
- Very exciting time to work with an awesome leadership team has proven experience commercializing biotech, including expertise in system and assay research and development, regulatory, intellectual property, engineering and manufacturing.
- This company is in growth mode and is bound for great things! This is an opportunity for you to help make a significant difference with this delivery to the world!
What YOU get to DO at this growing company:
- 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 laboratory activities.
- Adhere to our client's design control, Good Documentation Practice (GDP) and quality system procedures.
- Support stability protocols, plans and actions.
- Support the 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.
What you NEED to SUCCEED in this challenging role:
- 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.