Lab Build & Operations Lead - On-Site CLIA Lab (Florida)

Mission Neko is redefining what prevention means, from treating illness when it arrives, to sustaining health before it's ever at risk. Our mission: make data-driven, preventative care accessible to more people, before symptoms appear. In a single, non-invasive visit under an hour, proprietary technology and direct clinical care combine to deliver personalised, actionable insights. It's a team that thinks in 10x, not 10%. Every role here plays a part in building a world where prevention is the norm, and where your work genuinely helps people live longer, healthier lives. Role Purpose This is a two-phase role. First, you build the lab. Then you run it. You'll lead the setup and validation of Neko's on-site clinical laboratory in Miami — Abbott Alinity platforms, SOPs, workflows, regulatory readiness — and bring it through to a compliant go-live under CLIA, CMS, and the state of Florida. After go-live, you become the on-site technical owner and people leader: responsible for instrument performance, testing quality, inspection readiness, and the development of the Laboratory Technologist team that runs the bench day to day. You'll partner closely with the Head of Labs, who provides multi-site oversight and holds final regulatory sign-off. But the lab on the ground — and the team in it — is yours. What You'll Deliver in the First 6–12 Months Lead laboratory setup and go-live readiness, taking the lab from empty space to compliant patient testing under CLIA, CMS, and Florida State regulations. Complete full instrument and assay validation on Abbott Alinity platforms — accuracy, precision, reportable range, reference intervals, analytical performance — with complete, inspection-ready documentation. Establish the SOPs, workflows, and validation practices the lab will run on for years. Build them so they're safe, efficient, and repeatable by the team that comes after you set them. Keep the lab inspection-ready at all times — validation, QC, maintenance, and corrective-action records complete and current. Transition the lab from setup mode into stable day-to-day operations, holding testing quality, turnaround times, and instrument reliability steady through the shift. Manage and develop the Laboratory Technologist team — through 1:1s, performance feedback, technical coaching, and the day-to-day mentorship that turns good lab techs into great ones. Serve as the on-site escalation point for any technical, operational, or quality issue affecting laboratory testing. Build the culture of the lab — quality, accountability, and continuous improvement — from day one. What We're Hiring For Builder Who Can Also Run -- You've stood up a lab before — or something close to it — and you know what go-live actually looks like. But you also know the harder work starts after. You're not the kind of person who builds something impressive and then loses interest when it becomes operational. You take pride in steady-state performance just as much as the launch. Validation Is Your Native Language -- You don't treat validation as paperwork. You understand why every parameter matters, what each one protects against, and how to defend the documentation to an inspector. Accuracy, precision, reportable range, reference intervals — you can talk through your validation strategy before you start, and you can show your work after. Inspection-Ready Is a Default, Not a Project -- You don't prepare for inspections. You operate in a way that means you're always ready. Documentation is current because that's how you work, not because an audit is coming. When something deviates, you address it and document it the same day — not the same week. The Technical Owner People Trust -- When something doesn't work — an instrument flag, an unexpected QC result, a workflow that's quietly breaking down — you're the person the team brings it to. You troubleshoot rigorously, you decide clearly, and you communicate honestly with the Head of Labs about what you've found. You don't minimize problems and you don't catastrophize them. Develops the Team You Rely On -- The lab is only as strong as the Technologists running it. You take their development seriously — not as a side responsibility, but as core to your job. You give honest feedback, you teach the why behind the SOP, and you build people who could eventually do what you do. When something goes wrong on the bench, you treat it as a coaching moment, not a blame moment. Minimum Requirements 5+ years of experience in a supervisor or lead technologist role within a high-complexity clinical laboratory environment Bachelor's degree in Medical Laboratory Science, Clinical Laboratory Science, or a related field. Active Florida Clinical Laboratory Supervisor license, with specialty designation covering clinical chemistry, immunology, and hematology Hands-on experience with automated chemistry and immunoassay platforms. Demonstrated experience with laboratory validation, quality systems, and CLIA requirements. Preferred MLS (ASCP) or equivalent certification. Direct experience with Abbott Alinity or Abbott ARCHITECT platforms. Prior ownership of laboratory setup, instrument validation, or go-live activities. Experience overseeing day-to-day laboratory operations in a clinical setting. Familiarity with laboratory information systems (LIS), such as Epic or Cerner. Compensation & Benefits Paid Time Off & Holidays Medical, Dental, Vision, and Life Insurance 401(k) Retirement Plan Commuter Benefits Wellness Rewards Program Complimentary full Neko scan for you and eligible family members #J-18808-Ljbffr