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Associate Director, Assay Development

Organization
Talis Biomedical
Job Location
230 Constitution Dr.
Menlo Park, CA 94025
United States
Job Description

Company Overview:

Talis is an exciting biomedical company that has developed an innovative, proprietary, point-of-care molecular diagnostics platform - we have also recently developed a rapid COVID-19 assay test that runs on this platform.  We enable rapid testing across a wide range of healthcare settings. The platform consists of a compact instrument, single-use test cartridges, and software. Contribute and be a significant team member as we develop other assays and launch other pipeline products in the infectious disease area.

Our visionary team combines depth of experience with passion to deliver.  Our pioneering tests are designed to enable caregivers to quickly detect infectious organisms and enable individualized care. From the doctor’s office to the hospital bedside, to remote care settings, we are re-defining the treatment of infectious diseases. 

Talis is committed to excellence in advancing improved health outcomes.  This commitment, along with a dynamic team culture, drives our mission to develop and commercialize novel approaches. 

Position Summary:

We are seeking a talented, motivated and driven Associate 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 molecular diagnostics.

You will lead an Assay Development Subteam 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 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. Your prior IVD Development experience will enable you to successfully transfer validated designs to the Operations organization. You will write assay development plans, protocols and reports and work collaboratively with other departments, including Assay Research, Biostatistics, Engineering, Quality, Operations and Commercial. You will mentor more junior scientists and associates on the rigorous development of new assays. Prior In Vitro Diagnostic (IVD) development experience is a must.

 

Specific responsibilities include, but are not limited to:

- Write Assay Development and Verification plans, protocols and reports; collaborate with systems engineering on traceability; adhere to CRF 21 820.30 (Design Controls).

- Lead an Assay Development Subteam, a cross-functional team responsible for executing on the Development and Verification Plans.

- Design and execute formulation guard-banding studies to ensure assay robustness on the TalisOne platform.

- 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 (for incoming, in-process and finished device).

- Troubleshoot problems and identify solutions to technical challenges.

- Present data at Development Subteam meetings, Core Team meetings and external meetings as needed.

- Hire, develop and manage junior staff as needed.

 

Required Education & Experience

- Ph.D. in Molecular Biology, Biochemistry, Biomedical Engineering, Microbiology or a related field with 7-10 years of experience in Biotechnology or Medical Device industries.

- At least 2 years’ experience in an IVD development environment.

- Hands-on expertise in nucleic acid amplification (qPCR, isothermal amplification) formulation optimization and troubleshooting required.

- Excellent written and oral communication skills.

- Experience with current 21 CFR 820 Quality System Regulation, specifically 820.30, Design Controls.

- Excellence in data-driven assay development and optimization and the ability to communicate these findings.

- Strong data analysis skills.

 

Addition Desired Experience

- Experience with design of experiment (DOE) methodology.

- Prior experience with Product Development Core Teams, and/or leading cross-functional assay development subteams.

- Experience integrating assays onto consumables.

 

Talis offers excellent health and welfare benefits, stock options, a 401(k) program with immediate Company match! 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 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.

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