The Opportunity

Reporting to the VP of Product Development, this role will lead a team of Automation Engineers (US-based) as well as leverage global collaboration to fully automate Universal DX's colorectal cancer test for verification and validation testing. Additionally, this role will play a critical role in technology transfer of Universal DX's colorectal cancer test to a strategic partner site (US-based) for regulatory approval and commercialization.  You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancer. As part of the team, you will be in a Company that aims to have a huge positive impact on society by achieving the ambitious purpose of "making cancer a curable disease by detecting it earlier".

Why Now?

This is an exciting time to be at Universal DX. We are growing rapidly and scaling our US operations by building up our team, starting our lab and business operations, and establishing strategic partnerships. We are looking for passionate changemakers to be a part of our journey in this expansive time for us.

How you'll contribute:

Lead a team of Automation Engineers (US-based) and collaborate with EU-based Automation and assay development teams to deliver automated solutions/workflows that meet the product requirements of Universal DX's colorectal cancer test.
Function as a technical SME to identify and address unmet automation needs through cross functional collaboration with scientists, engineers, and project teams.
Represent the automation function both internally and externally, articulating complex scientific concepts to diverse functional groups and stakeholders.

Work closely with Quality Assurance, Information Technology, and Regulatory groups to ensure conformance of NGS workflows with regulatory requirements as appropriate.

• Anticipate and mitigate potential challenges related to automation integration. Oversee product
testing, risk analysis, and validation to ensure automation engineering solutions meet business objectives and customer needs
• Stay abreast of the latest automation technologies and trends. Evaluate emerging technologies and assess their potential impact on Universal DX projects. Make recommendations for technology adoption based on feasibility, cost-effectiveness, and strategic fit
• Manage complex technical projects, balancing scope, timeline, and budget
• Create metrics and KPIs to monitor the success and impact of automation integration efforts. Regularly assess the efficiency gains, quality improvements, and cost savings achieved through design for automation initiatives
• Ability to travel 20% of working time away from work location, may include overnight/weekend travel.

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Qualifications:

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• Bachelor's degree in an engineering discipline (preferably Electrical, Automation/Computer, Electronics, Chemical, Mechanical, Process, Biotech or Manufacturing Engineering) or life sciences discipline (Molecular Biology, Biochemistry, Genetics) with an advanced degree (Business Management or related technical discipline) preferred.
10+ years of prior experience in automation engineering-related position with at least 5 years in a management role, preferably involving highly technical products incorporating customized machine control hardware/software integration.
• Experience in a regulated environment is a must and prior experience with clinical diagnostic products is highly desirable.

• Hands-on experience in the deployment of high throughput and fully automated NGS-based diagnostics in a Clinical laboratory setting is a strong plus.
• Proven proficiency in converting NGS workflows from manual to automated process on liquid handling systems. Deep familiarity with NGS laboratory instrumentation, including liquid handling robots (and associated software) and automation of NGS library prep workflows.
• Experience with Illumina NGS platforms, liquid handling automation systems, and the molecular biology of NGS assays and sequencing workflows.
• Demonstrated expertise in molecular biology wet lab skills, including DNA extraction and purification, PCR and qPCR, DNA library preparation etc.
• Previous experience in leading and managing teams, fostering collaboration with stakeholders, and driving results. Experience managing projects with multiple interdependencies and global collaboration is a strong plus.
• Ability to train others in NGS laboratory techniques and operation
• Awareness of and prior experience with implementing Continuous Improvement (CI) process(es) is a plus
• Exceptional communication skills and proven leadership in influencing stakeholders across
functional boundaries
• Proven ability to work in a fast-paced and dynamic environment, managing multiple priorities and
projects simultaneously.

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