Technical Operations Lead at Gaia Health | CA, US | Rezi

Technical Operations Lead at Gaia Health

Technical Operations Lead

Gaia Health · CA, US

3 days ago

Technical Operations Lead

Gaia Health · CA, US

3 days ago
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About the Role

Gaia is seeking a hands-on Technical Operations professional to lead facility commissioning and manufacturing scale-up. This role involves managing facilities from concept to qualified state and driving the manufacturing strategy and equipment infrastructure for production scaling. It offers ownership over tangible outcomes like establishing new facilities, scaling processes, and building automation infrastructure.

Responsibilities

  • 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.
  • 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.

Requirements

  • 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.

Location

  • San Francisco

Work Type

  • Onsite
  • Travel

Experience Level

  • 8+ years

Education Level

  • Bachelor's degree in Engineering or related technical field (or equivalent experience)

Salary/Compensations

  • $125,000 – $190,000

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
  • Generous equity

About the Company

  • 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.
  • 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.
  • 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.
  • Like our products, we are building Gaia by design.
  • The quality of the company should match the ambition of the science.
  • 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.
  • 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.