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 groupWrite 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 projectsProvide technical expertise to support new molecular assay development and modify and improve current molecular assay formulationsInterface 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 neededApply lean six sigma techniques and DOE to accelerate time to marketEnsure 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 transferCreate necessary templates for technical protocols, plans and reports that successfully support regulatory submissionsDevelop raw material specifications and QC specifications as neededHelp 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 planningBe 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 templatesControl 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 PCRExperience with dry-down reagent techniques is a plusFamiliarity with managing complex tasks and delivering innovative solutionsStrong multidisciplinary background with comprehensive knowledge of systems engineeringExcellent understanding of quality systems, regulatory requirements, development and manufacturing processesExperience in design control and product lifecycle management is a mustPrevious experience with regulatory submissions, US and OUS is a mustExperience in iso-thermal amplification methods is highly desirableExperience in developing POC products is highly desirableAbility to work successfully across disciplines in a fast-paced, collaborative and cross-functional team environmentExperience in developing and commercializing diagnostic products in a GLP/GMP environment is a mustExperience working in biosafety level 2 (BSL-2) environment and willingness to work with infectious or otherwise biohazardous materialsExcellent written and verbal communication skills as well as ability to communicate effectively with scientists and engineers from a wide range of technical backgroundsSalary Range: $131,000 - $142,000 per yearWe are an equal opportunity employer and value diversity at Alveo Technologies.
We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.Apply for this job
