Scientist, Assay Design Transfer

About Alveo

Alveo Technologies is the first company to make molecular detection and diagnostics universally accessible – on the farm, in the field, in the clinic, or in the manufacturing plant – helping prevent or significantly limit the destructive impact of viruses, fungi, bacteria, and other pathogens by detecting earlier at the Point of Need™. Alveo’s rugged and portable, multiplex-capable diagnostic platform employs IntelliSense™, its patented method of direct electrical sensing of nucleic acid amplification to provide affordable, rapid, and accurate results. By enabling early pathogen detection, Alveo helps manage global health, food security, and supply chain resiliency by providing actionable insights at lightspeed. Know Sooner, Act Faster™ with Alveo. For more, visit: https://www.alveotechnologies.com/ 

Alveo Technologies is looking for a Scientist, Assay Design Transfer to work directly with the VP, R&D Assay Development to achieve company milestones in disease detection. The successful candidate will assist in planning experimental roadmaps, work collaboratively with other research staff, and optimize and develop assay products to meet objectives focused on Assay Design Transfer. This position will work closely with Engineering and cross-functional Product Development and Manufacturing teams to coordinate product timelines with other aspects of the product development. You will transfer current assays and molecular technologies to the manufacturing counterpart. You may also assist in writing patents to protect Alveo’s intellectual property and journal articles to publish results.    You Will:  Assist the VP, Assay Development with development and execution of strategic initiatives for the Assay Development R&D group

Write documents for study plans for feasibility developmental phases 

Write reports for concluded studies in feasibility and developmental phases 

Work with Assay Development Scientists to create specifications and formulations for raw materials such as primers, enzymes, chemical/biological reagents and buffers required for carrying out manufacturing of successful wet reagent formulations 

Hands-on experience in conducting technical experiments to develop sample-to-answer molecular diagnostics assays and analyze, summarize the experimental data to achieve timely execution of projects

Provide technical expertise to support new molecular assay development and modify and improve current molecular assay formulations

Interface on a regular basis with manufacturing personnel to continuously support and successfully complete the design transfer of new assays from R&D to Manufacturing. 

Work with Manufacturing to understand the scientific aspects of the manufactured product as needed

Apply lean six sigma techniques and DOE to accelerate time to market

Ensure that any new and/or improved reagent products and processes are adequately tested, guard-band studies completed to ensure successful development and verification phase and design transfer

Create necessary templates for technical protocols, plans and reports that successfully support regulatory submissions

Develop raw material specifications and QC specifications as needed

Help to create product FMEAs (Failure Mode and Effects Analysis) and proactively identify, manage and escalate product and project risks and issues to relevant stakeholders, lead development and delivery of tactical and achievable mitigation and contingency planning

Be involved in cross-functional product and process risk assessment, root cause analysis and troubleshooting 

Lead "lessons learned" sessions, share lessons among project leaders and other teams, integrate lessons into existing processes, tools and templates

Control and propagate an exceptional quality of the documentation and analysis of results that will be submitted to regulatory agencies

Your Background Should Include:  A Ph.D. degree in Biochemistry, Molecular Biology, Microbiology or related field with 5-8 years of IVD experience and a proven track record in product development from feasibility to commercialization. For Master’s degree candidates, 8+ years experience is required.  

Understanding of Primer formulation characteristics such as purity,yield and pooling 

Expertise in genomics and molecular biology, including principles of nucleic acid chemistry, primer design and technologies for gene target amplification using isothermal and PCR

Experience with dry-down reagent techniques is a plus

Familiarity with managing complex tasks and delivering innovative solutions

Strong multidisciplinary background with comprehensive knowledge of systems engineering

Excellent understanding of quality systems, regulatory requirements, development and manufacturing processes

Experience in design control and product lifecycle management is a must

Previous experience with regulatory submissions, US and OUS is a must

Experience in iso-thermal amplification methods is highly desirable

Experience in developing POC products is highly desirable

Ability to work successfully across disciplines in a fast-paced, collaborative and cross-functional team environment

Experience in developing and commercializing diagnostic products in a GLP/GMP environment is a must

Experience working in biosafety level 2 (BSL-2) environment and willingness to work with infectious or otherwise biohazardous materials

Excellent written and verbal communication skills as well as ability to communicate effectively with scientists and engineers from a wide range of technical backgrounds

Salary Range: $131,000 - $142,000 per year