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
