Laboratory Operations & Facilities Manager

Laboratory Operations & Facilities Manager

About SiPhox Health

SiPhox Health is building a next-generation, silicon-photonics–based blood testing platform that brings advanced clinical diagnostics into the home. Our system integrates precision optics, microfluidics, and immunoassay chemistry into a compact, high-performance device capable of delivering lab-quality results from a small capillary sample.

We are building not just a lab, but a controlled, production-grade environment where biology, hardware, and manufacturing discipline intersect.

The Role

We are seeking a Laboratory Operations & Facilities Manager who brings manufacturing-grade operational discipline into a BSL-2 laboratory environment.

This is not a traditional academic lab role.

You will own a space that operates with the rigor of a regulated manufacturing floor, where gowning, material flow, environmental control, and adherence to SOPs are critical to product quality and regulatory compliance.

You should be equally comfortable:

• Enforcing gowning protocols and contamination control
• Managing equipment qualification and uptime
• Responding to facility failures in real time
• Operating within (and improving) a quality system

This is a hands-on role. You are the person who makes sure everything works—and keeps working.

Key Responsibilities

Laboratory Operations (Production Mindset)

• Run day-to-day operations of a BSL-2 lab with a manufacturing and quality-first mindset
• Establish and enforce gowning protocols, material flow, and contamination control practices
• Own lab readiness: everything calibrated, stocked, documented, and audit-ready at all times
• Manage full equipment lifecycle: procurement, IQ/OQ/PQ, calibration, maintenance, and uptime
• Maintain strict control over inventory, reagents, and consumables, including traceability
• Ensure compliant handling of biological samples, chemicals, and waste
• Drive continuous improvement of SOPs, work instructions, and operational workflows

Facilities & Environmental Control

• Own facility systems: HVAC, pressure differentials, temperature, humidity, and monitoring systems
• Monitor and maintain cleanroom / controlled environment conditions (including gowning areas, dry rooms, fridges/freezers, etc.)
• Act as first responder for facility issues (power, alarms, equipment failures)
• Coordinate vendors, contractors, and service providers
• Manage lab layout, equipment moves, and space optimization
• Support shipping/receiving, including temperature-sensitive and regulated materials

Quality, EHS, and Compliance

• Operate within and help strengthen a quality management system (FDA / ISO 13485)
• Own biosafety (BSL-2), chemical safety, and environmental health programs
• Ensure the lab is always inspection-ready
• Support audits, CAPAs, and regulatory interactions
• Partner closely with QA/RA to ensure alignment between operations and compliance

Operational Leadership

• Act as the operational backbone for scientists and engineers
• Bring structure, discipline, and reliability to a fast-moving environment
• Communicate clearly on risks, issues, and system performance
• Lead by example—high standards, high ownership, no task beneath you

Qualifications

Required / Strongly Preferred

• 5 years of experience in manufacturing, regulated lab operations, or production environments
• Hands-on experience working under a quality system (FDA, ISO 13485, GMP, or similar)
• Direct experience with gowning, contamination control, and controlled environments
• Experience managing equipment lifecycle (IQ/OQ/PQ, calibration, maintenance)
• Strong operational instincts: you notice when something is off and fix it
• Comfortable being on-site and hands-on daily

Highly Desirable

• Experience in a BSL-2 lab or diagnostic / clinical environment
• Experience with cleanrooms, dry rooms, or controlled manufacturing environments
• Familiarity with environmental monitoring systems and facility infrastructure
• Ability to troubleshoot mechanical, electrical, or lab instrumentation issues
• Experience scaling operations or setting up a new lab or facility

Education

• Bachelor’s degree or higher in a relevant technical field preferred

What We’re Really Looking For

Someone who:

• Treats a lab like a production system, not a research playground
• Understands that gowning, discipline, and process control = product quality
• Can walk into a room and immediately see what’s wrong
• Fixes problems before others notice them
• Brings order, reliability, and calm execution to a chaotic startup environment