Facilities & Lab Operations Manager

About Genalyte

At Genalyte, we're revolutionizing diagnostic testing to empower a healthier future. Genalyte is a San Diego‑based diagnostics company developing the Merlin platform, a novel photonic ring resonator‑based system designed to deliver rapid, multiplexed diagnostic results. We believe timely, accurate health insights shouldn't be a luxury, but a necessity, and we are driven by a vision where advanced diagnostic capabilities are accessible, efficient, and seamlessly integrated into healthcare. Genalyte is more than a laboratory; we are advocates for health empowerment, dedicated to providing insights that can transform lives and communities.

Why Work For Us

Joining Genalyte at this pivotal pre‑commercial stage means your work will have real, visible impact - on our technology, our culture, and ultimately on how diagnostic testing is delivered to patients. You'll work closely with leadership to build something meaningful from the ground up. Genalyte offers competitive compensation including base salary, significant equity participation, and a comprehensive benefits package. This is a rare opportunity to grow alongside a high‑impact company at an exciting moment in its journey.

Position Summary

The Facilities & Lab Operations Manager ensures the safe, reliable, and compliant operation of Genalyte's facilities, controlled environments, and critical equipment in support of a pre‑commercial diagnostics platform. This is a hands‑on, on‑site role spanning building systems and the Building Management System (BMS); clean room, wet lab, hardware lab, CLIA laboratory, and manufacturing environments; and the equipment calibration and preventive‑maintenance program that underpins quality and inspection readiness. The role partners closely with Manufacturing, Quality, and R&D and currently operates as a hands‑on individual contributor with no direct reports, with the autonomy to own facilities and lab operations end to end.

Essential Functions & Responsibilities

These may include, but are not limited to, the following:

Building Systems & Controlled Environments

• Own the Building Management System (BMS): monitor and maintain temperature and humidity within specification across clean room, wet lab, hardware lab, and manufacturing spaces.
• Anticipate and prevent environmental excursions by proactively adjusting the BMS for seasonal and daily weather conditions (precooler, humidification, and related setpoints), keeping controlled environments in specification at all times.
• Manage environmental monitoring (continuous temperature/humidity logging), respond to alarms and excursions, and maintain the associated records.
• Maintain critical utilities supporting the labs and manufacturing, including process/DI water systems and specialty gas supply.
• Respond to building and environmental emergencies, including after‑hours and on‑call escalation.

Equipment, Calibration & Preventive Maintenance Program

• Own the equipment management program - onboarding and asset tracking, preventive‑maintenance schedules, and calibration cycles - maintained in the quality system (e.g., QCBD).
• Run the monthly PM and calibration schedule; coordinate internal calibrations and external vendor calibrations; ensure certificates and records are captured and inspection‑ready.
• Manage calibration and service vendors and the associated recall and scheduling cadence.
• Support manufacturing equipment validation and qualification activities (IQ, OQ, PQ) in partnership with Manufacturing and Quality.
• Report program metrics (PM and calibration status) into quality and operational reviews.

Compliance, EH&S & Safety

• Ensure facilities and equipment programs comply with applicable GMP, ISO 13485, CLIA, building codes, fire/life‑safety regulations, and OSHA requirements.
• Support EH&S activities, including safety and new‑hire training and hazardous‑materials and biohazard‑waste management, and maintain inspection readiness.
• Coordinate fire and life‑safety inspections and drive remediation items to closure.
• Develop, maintain, and test security policies and access controls.

Vendor, Budget & Facilities Operations

• Manage daily operations across facilities, including janitorial, repair services, equipment installation and delivery, electrical and mechanical work, and moves.
• Source and manage vendors and service contracts; coordinate the landlord and property‑management relationship.
• Own the facilities budget, including annual operating plan development and long‑range planning.
• Maintain a comprehensive facilities plan supporting current headcount and future growth.

Cross-functional Partnership & Workplace

• Partner with Manufacturing, Quality, Finance, Procurement, Legal, R&D, and IT to meet company needs in a timely, cost‑effective manner.
• Act as a culture champion, enhancing the employee experience and reinforcing organizational values.
• Perform other duties as assigned.

Qualifications

Required

• 5+ years of facilities and/or laboratory operations management in a regulated environment (medical device, IVD/diagnostics, pharma, or biotech).
• Hands‑on experience managing a Building Management System (HVAC and clean room temperature/humidity controls).
• Experience owning an equipment calibration and preventive‑maintenance program, including maintaining calibration and PM records in a quality system (QCBD or equivalent) and supporting audits and inspections.
• Working knowledge of GMP, ISO 13485, CLIA, building codes, fire/life‑safety regulations, and OSHA requirements.
• Experience with clean rooms / controlled environments and hazardous and biohazard waste handling.
• Ability to read and interpret building plans and equipment specifications.
• Associate degree or technical trade certification, or equivalent hands‑on experience.

Preferred

• Experience in a commercial or scaling diagnostics / medical‑device company.
• Equipment qualification experience (IQ/OQ/PQ).
• Facilities certification (FMP/CFM) or relevant trade licenses.
• Familiarity with environmental monitoring systems, process/DI water systems, and specialty gas systems; metrology background a plus.

Travel Requirements

Minimal; occasional travel to storage facilities and picking up equipment (

Physical Requirements & Work Environment

This is an on‑site role based at Genalyte's San Diego headquarters. It involves regular hands‑on work in laboratory, clean room, manufacturing, and mechanical/rooftop environments, including standing and walking for extended periods, lifting up to approximately 40 lbs, and occasional after‑hours or on‑call response to building or environmental alarms. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Compensation

The base salary range for this role is $100,000 - $140,000 per year. Individual pay may vary based on job‑related skills, experience, and relevant education or training. In addition to base salary, this role includes meaningful equity participation, and a comprehensive benefits package (health, dental, vision, and a flexible time‑off policy).

Equal Employment Opportunity

Genalyte, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected characteristic.