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Gaia Health

Fertility insurance and IVF cost predictions

Technical Operations Lead

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeSan Francisco, CA, USA

About the Job

Requirements

  • A bachelor's degree in Engineering or a related technical field, or equivalent experience.
  • At least 8 years of experience in pharmaceutical or biotechnology technical operations, manufacturing, or facility engineering, including direct facility commissioning experience.
  • Demonstrated experience with combination drug/device products, including manufacturing considerations from Phase 1 through commercial stages.
  • Experience with capacity planning and scale-up strategy in a regulated manufacturing environment.
  • Working knowledge of current Good Manufacturing Practice (cGMP) requirements.
  • Experience managing equipment and automation vendors, including contract negotiation and implementation oversight.
  • Experience with supplier identification and qualification, and inventory and demand forecasting in a regulated manufacturing setting.
  • Strong project management skills and the ability to manage multiple concurrent workstreams and sites.
  • Willingness and ability to travel frequently, up to 50%, and spend extended time onsite at facilities in California and Florida, including during commissioning and startup phases.

Responsibilities

  • Own and drive facility commissioning 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, coordinating with construction, engineering, quality, and facility teams.
  • Partner with Quality and Regulatory to ensure commissioning activities meet cGMP or other relevant requirements.
  • Troubleshoot issues 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 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 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.

About the Company

Gaia Health

Fertility insurance and IVF cost predictions

Gaia Health uses data‑driven models to make fertility care more affordable and predictable. It analyzes personal and anonymized IVF clinic data with AI and machine learning to forecast the likelihood of treatment success for individuals. Based on this forecast, Gaia offers personalized financial plans and insurance that cover the full treatment cost only if a live birth occurs, reducing patients’ financial risk. The service also handles all payments with a single fixed price and supports IVF as well as egg freezing, egg donation, and embryo batching, plus add‑on patient support; its goal is to improve access to fertility care by making treatments predictable, affordable, and patient-centered.

Company size
Not listed
Company stage
Not listed
Total funding
Not listed
Headquarters
Boston, MA
Founded
2025

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