Aspectbiosystems

Head of Manufacturing

Fremont, California. Posted a month ago

The role

The Head of Manufacturing will oversee facilities, lab operations, safety, and aseptic manufacturing to support bioprinted tissue therapeutic programs. This role involves scaling physical operations, optimizing infrastructure, and managing costs to ensure clinical-grade production.

What you will do

  • Develop and execute manufacturing operations strategy.
  • Oversee aseptic manufacturing operations and cleanroom controls.
  • Partner cross-functionally to enable execution from discovery to clinical readiness.
  • Build, lead, and mentor a manufacturing operations team.
  • Manage lab operations including equipment lifecycle, maintenance, and inventory.
  • Support implementation of manufacturing best practices and training protocols.
  • Lead day-to-day site operations and long term facilities planning.
  • Oversee installation, qualification, maintenance, and calibration of manufacturing equipment.
  • Develop and maintain preventative maintenance programs.
  • Collaborate with senior leadership on operational expense planning and budgets.

Required qualifications

  • Master’s degree in Engineering, Biotechnology, Life Sciences, or a related discipline
  • 10+ years of experience in biotech or pharmaceutical operations
  • 5+ years in a senior leadership role overseeing GMP manufacturing and aseptic processing
  • Deep expertise in aseptic manufacturing operations, cleanroom controls, environmental monitoring, and equipment qualification (IQ/OQ/PQ) within a strict cGMP-regulated environment
  • Comprehensive understanding of facility design and operations, critical utility management, and EHS regulatory standards for biomanufacturing environments

Nice to have

  • experience in cell and gene therapies, device and combination products

Benefits

  • equity
  • comprehensive benefits package
  • support for continuous learning and career progression

About the company

Aspect Biosystems is a biotechnology company pioneering the development of a novel category of regenerative medicine. The company uses a tissue therapeutic platform integrating AI-powered bioprinting technology, therapeutic cells, hypoimmune cell engineering, and advanced biomaterials.

Head of Manufacturing at Aspectbiosystems | JobZoey