Director, Assay Development
About the Company
Our purpose at Talis Biomedical is to advance health equity and outcomes by delivering accurate infectious disease testing in the moment of need, at the point of care.
While timely diagnosis of infectious diseases is critically important to enable effective treatment, testing is primarily performed in centralized laboratories, which require samples to be shipped for processing, delaying the return of results by days. Point-of-care testing solves this problem by delivering the timely information necessary for clinical care.
To deliver our purpose we focus on three things:
- Putting customers and patients first
- Making Talis a great place to work
- Living our values to Dream Big, Share Our Screens, Serve Others, Bring Our "A" Game, and Build Trust
Position Summary:
We are seeking a talented, motivated and driven Director, Assay Development within the R&D division to enable development of rapid diagnostic tests. This high visibility position is an excellent opportunity for individuals seeking a scientific leadership opportunity in the field of moleculr diagnostics.
You will lead members in Assay Development team in assay development and be a pivotal member of the Product Core Team representing the Assay Development function. You will lead all aspects of Assay Development and Assay Verification/validation activities. You will apply your prior experience with Design Controls to develop robust and reliable Product and play a critical role in demonstrating the validity of new assays. You will write assay development plans, protocols and reports and work collaboratively with other departments. You will lead the effort in transferring validated designs to the Operations organization. You will mentor junior scientists and associates on the rigorous development of new assays. Prior molecular In Vitro Diagnostic (IVD) product development experience in infectious disease is preferred. Experience in Loop Mediated Amplification technology is a plus.
This job is located in our Chicago, IL location and may require occasional travel to our Redwood City, California site.
Specific responsibilities include, but are not limited to:
- Lead Assay Development teams in assay development, optimization, verification and validation.
- Design and execute guard-banding studies to ensure robustness on the assays.
- Write Assay Development, Verification and validation plans. Directing in writing protocols and reports.
- Work with the Bioinformatics Team to finalize assay-specific calling algorithms.
- Represent Assay Development on the Product Core Team; collaborate with Program management to build bottoms-up timelines, identify and communicate risks.
- Collaborate with the Reagent/QC development team to establish manufacturing work instructions and quality control specifications.
- Troubleshoot problems and identify solutions to technical challenges.
- Present data at Development Sub team meetings, Core Team meetings and external meetings.
- Hire, develop and manage Assay Development team, including Scientists.
Required Education & Experience
- D. in Molecular Biology, Biochemistry, Microbiology or a related field with 10+ years of experience in Biotechnology or molecular IVD industries.
- 5+ years' experience in infectious disease IVD product development, from bench to commercialization.
- 3+ years' management experience, and strong leadership skills.
- Hands-on expertise in nucleic acid amplification (qPCR, isothermal amplification) technology from assay design to optimization and troubleshooting is required.
- Excellence in trouble shooting and optimization skills. Being able to multitasking and at the same time stay focused is highly desirable.
- Excellent written and oral communication skills.
- Experience with current 21 CFR 820 Quality System Regulation, specifically 820.30, Design Controls.
Additional Desired Experience
- Prior experience with Product Development Core Teams, and/or leading cross-functional assay development sub teams.
- Experience integrating assays onto consumables.
Talis Biomedical offers a comprehensive health and well-being benefits programs, long-term equity incentives, time-off policies, a 401(k) retirement savings plan with an immediate Company match, Education Assistance Program, a rotating suite of snacks, Happy Hours, office perks, and other fun company events! Best of all, join us by working at a growing company like Talis with dedicated and collaborative employees committed to making a difference in Health Care.
Talis Biomedical is proud to be an equal opportunity workplace. All aspects of employment decisions will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of any status protected under federal, state, or local law. We celebrate diversity and are committed to creating an inclusive environment for our colleagues. Talis Biomedical is an E-Verify Participation company.
More About Talis Biomedical:
Built on a foundation of world-class science and engineering, we are developing the Talis One platform, a sample-to-answer, cloud-enabled molecular diagnostic platform that could be rapidly deployed to distributed diagnostic settings in the United States and around the world to diagnose infectious disease at the point-of-care. The Talis One platform comprises a compact instrument, single-use test cartridge, and innovative software including a central cloud database. This system is designed to provide central laboratory levels of accuracy and be operated by an untrained user.
Talis has raised more than $500 million to date and went public in February 2021.
At Talis, we are dedicated to advancing health equity and outcomes through the delivery of highly accurate infectious disease testing in the moment of need, at the point of care.
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