Technical Operations Lead

Gaia Health; San Francisco (CA); On-site; USD 125,000 - 190,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

One Medical membership and 24/7 care

Generous PTO and company holidays

Life and Disability Insurance

401(k) retirement plan

Pre-tax commuter benefits

Job summary

Gaia Health is assembling its founding team in San Francisco to own facility commissioning and scale-up across production sites. You will drive equipment infrastructure, coordinate with Quality/Regulatory, and manage vendor relationships to meet cGMP requirements.

This high-impact role requires significant onsite presence and travel to project sites, with responsibility from concept through qualified, running state and into commercial-scale manufacturing.

Qualifications

• Bachelor's degree in Engineering or related technical field (or equivalent experience).
• 8+ years of pharmaceutical/biotech technical operations, manufacturing, or facility engineering, with direct experience in facility commissioning.
• Experience with combination drug/device products, including manufacturing considerations across Phase 1 through commercial stages.
• Experience with capacity planning and scale-up strategy in a regulated manufacturing environment.
• Working knowledge of cGMP requirements.
• Experience managing equipment and automation vendors, including contract negotiation and implementation oversight.
• Experience with supplier identification and qualification, and with inventory/demand forecasting in a regulated manufacturing setting.
• Strong project management skills with the ability to manage multiple concurrent workstreams and sites.
• Willingness and ability to travel frequently and spend extended time onsite at facilities, including during commissioning and startup phases.

Responsibilities

• Own facility commissioning activities from planning through startup, including design review, installation oversight, IQ/OQ/PQ, and production readiness.
• Develop and manage commissioning project plans, schedules, and budgets across multiple sites.
• Spend substantial time onsite at production facilities during buildout and startup phases, coordinating directly with construction, engineering, quality, and facility teams.
• Partner with Quality and Regulatory to ensure commissioning activities meet cGMP or other relevant requirements.
• Troubleshoot issues in real time onsite and drive resolution to keep projects on schedule.
• Develop and lead scale-up strategy for products moving from early clinical phases through commercial manufacturing.
• Build capacity models and planning tools to forecast production needs and identify bottlenecks ahead of demand.
• Partner cross-functionally with Process/Formulation Development, Quality, and Commercial teams to align scale-up timelines with business needs.
• Identify and de-risk technical and operational gaps as processes and volumes scale.
• Own vendor relationships for automation and manufacturing equipment supporting scaled operations.
• Lead equipment selection, specification, procurement, and implementation to support current and future manufacturing needs.
• Negotiate contracts, manage vendor performance, and ensure equipment delivery timelines align with facility and scale-up plans.
• Collaborate with engineering and automation vendors to integrate new equipment into existing manufacturing lines with minimal disruption.
• Identify and evaluate suppliers for raw materials, components, and services needed to support facility and manufacturing operations.
• Facilitate supplier qualification activities in partnership with Quality, ensuring new suppliers meet applicable regulatory and quality standards.
• Manage inventory forecasting to align material availability with production schedules, scale-up timelines, and capacity plans.
• Monitor supplier performance and lead resolution of supply issues that could impact production continuity.

Skills

Hands-on operations

Facility commissioning

Project management

Vendor management

Regulatory compliance

Inventory forecasting

Cross-functional collaboration

Education

Bachelor's degree in Engineering or related technical field

Tools

IQ/OQ/PQ procedures

Job description

About Gaia

Gaia’s vision is to fundamentally change our relationship with medicine.

Gaia’s vision is to fundamentally change our relationship with medicine. We have created a personalized drug delivery platform that turns the daily chore of taking medication into a monthly ritual. For chronic medications where missed doses can have serious or potentially life-threatening health implications, Gaia makes taking medication perfectly, simple. Our platform replaces the mental burden of adherence to give us more time, energy, and attention for what matters. We believe treatment should work not only in the body, but in the context of our lives. We’re initially targeting hormone replacement therapy (HRT) for perimenopause and menopause to launch our drug delivery platform. Every woman will experience menopause in her life, and more than 80% experience symptoms that damage their physiology, quality of life, and longevity. The treatment is hormone replacement therapy, and the current delivery modes are… subpar. The HRT market is rapidly growing following new FDA guidelines in 2026, and Gaia has partnered with leading OB-GYNs who have validated that our platform will become the preferred way for women to receive hormone treatment. We’re assembling our founding team in San Francisco to reimagine how medicine fits into our lives. If you want to build at the intersection of breakthrough science and deep human empathy, come join us.

The Role

We are looking for a hands-on Technical Operations professional to own facility commissioning and manufacturing scale-up across our network of production sites. This role sits at the intersection of engineering, quality, and operations — leading facilities from concept through qualified, running state, then driving the manufacturing strategy and equipment infrastructure needed to scale production as the business grows.

This is a high-impact, high-visibility role for someone who wants ownership over tangible outcomes: standing up new facilities, scaling processes from clinical to commercial volumes, and building the automation infrastructure that supports it. Significant onsite presence and travel to project sites is a core and expected part of this job.

What You’ll Own

Facility Commissioning

• Serve as the primary owner and driver of facility commissioning activities from planning through startup, including design review, installation oversight, equipment qualification (IQ/OQ/PQ), and production readiness
• Develop and manage commissioning project plans, schedules, and budgets across multiple concurrent sites
• Spend substantial time onsite at production facilities during buildout and startup phases, coordinating directly with construction, engineering, quality, and facility teams
• Partner with Quality and Regulatory to ensure commissioning activities meet cGMP or other relevant requirements
• Troubleshoot issues in real time onsite and drive resolution to keep projects on schedule

Manufacturing Scale-Up Strategy & Capacity Planning

• Develop and lead scale-up strategy for products moving from early clinical phases through commercial manufacturing
• Build capacity models and planning tools to forecast production needs and identify bottlenecks ahead of demand
• Partner cross-functionally with Process/Formulation Development, Quality, and Commercial teams to align scale-up timelines with business needs
• Identify and de-risk technical and operational gaps as processes and volumes scale

Automation & Equipment Vendor Management

• Own vendor relationships for automation and manufacturing equipment supporting scaled operations
• Lead equipment selection, specification, procurement, and implementation to support current and future manufacturing needs
• Negotiate contracts, manage vendor performance, and ensure equipment delivery timelines align with facility and scale-up plans
• Collaborate with engineering and automation vendors to integrate new equipment into existing manufacturing lines with minimal disruption

Supply Chain Management

• Identify and evaluate suppliers for raw materials, components, and services needed to support facility and manufacturing operations
• Facilitate supplier qualification activities in partnership with Quality, ensuring new suppliers meet applicable regulatory and quality standards
• Manage inventory forecasting to align material availability with production schedules, scale-up timelines, and capacity plans
• Monitor supplier performance and lead resolution of supply issues that could impact production continuity

Your Background

• Bachelor's degree in Engineering or related technical field (or equivalent experience)
• 8+ years of experience in pharmaceutical/biotech technical operations, manufacturing, or facility engineering, with direct experience in facility commissioning
• Demonstrated experience with combination drug/device products, including manufacturing considerations across Phase 1 through commercial stages
• Experience with capacity planning and scale-up strategy in a regulated manufacturing environment
• Working knowledge of cGMP requirements
• Experience managing equipment and automation vendors, including contract negotiation and implementation oversight
• Experience with supplier identification and qualification, and with inventory/demand forecasting in a regulated manufacturing setting
• Strong project management skills with the ability to manage multiple concurrent workstreams and sites
• Willingness and ability to travel frequently and spend extended time onsite at facilities, including during commissioning and startup phases

Compensation

Gaia is committed to fair and equitable compensation practices. The annual salary range for this role is $125,000 - $190,000. Compensation is determined based on your qualifications and experience. Our total compensation package also includes generous equity in Gaia.

Benefits

• Comprehensive medical, dental, and vision insurance with HSA and FSA options
• One Medical membership, 24/7 virtual care, and mental health support
• Generous paid time off, company holidays, and sick time
• Life and Disability Insurance
• 401(k) retirement plan
• Pre-tax commuter benefits for transit and parking

Building Gaia

Like our products, we are building Gaia by design. The quality of the company should match the ambition of the science. At this stage, hiring is one of the most consequential forms of company design. Every person who joins Gaia will shape what we build, how we build it, and what it feels like to work here.

We look for people who care deeply about the quality of their work and the people they build alongside. People who move with urgency without lowering the bar, who are ambitious without losing their humanity, and who want their work to matter beyond the next milestone. We want to build a company that can last for hundreds of years and make life better for the generations that follow.

We’re assembling our founding team in San Francisco. The people who join now will help launch our first product in late 2027, prove an entirely new model of care, and define what Gaia becomes.

Compensation Range

Compensation Range: $125K - $190K