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Aspect Biosystems

Bioprints allogeneic tissue therapeutics

Head of Manufacturing

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeFremont, CA, USAIn-person

About the Job

Requirements

  • A master's degree in Engineering, Biotechnology, Life Sciences, or a related discipline, plus 10 or more years of experience in biotech or pharmaceutical operations; experience in cell and gene therapies, device and combination products is preferred, including 5 or more 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 current Good Manufacturing Practice-regulated environment.
  • Comprehensive understanding of facility design and operations, critical utility management, and environmental, health, and safety regulatory standards for biomanufacturing environments.
  • Ability to build and mentor high-performing operational teams.
  • Ability to align cross-functional teams and manage vendor relationships to execute complex project timelines.

Responsibilities

  • Develop and execute the manufacturing operations strategy in alignment with organizational goals and program timelines.
  • Oversee aseptic manufacturing operations, including cleanroom controls, gowning procedures, environmental monitoring, and material and personnel flow, to maintain contamination control and comply with Good Manufacturing Practice standards.
  • Partner cross-functionally to ensure facilities and manufacturing operations enable execution from discovery through clinical readiness.
  • Build, lead, and mentor a high-performing manufacturing operations team, fostering continuous improvement, Good Manufacturing Practice compliance, and operational excellence.
  • Manage lab operations, including equipment lifecycle, maintenance programs, calibration, and inventory management systems.
  • Support implementation of manufacturing best practices, including documentation systems, materials management, and training protocols.
  • Lead day-to-day site operations and long-term facilities planning, ensuring labs, offices, and production areas are optimized, safe, and compliant.
  • Oversee installation, qualification (IQ/OQ/PQ), maintenance, and calibration of critical manufacturing equipment, ensuring performance, data integrity, Good Manufacturing Practice compliance, and asset lifecycle management.
  • Develop and maintain preventative maintenance programs for manufacturing facilities and equipment, ensuring compliance with Good Manufacturing Practice requirements and managing critical building systems.
  • Collaborate with senior leadership on long-range operational expense planning and annual budgets, and assess and implement facility expansion plans aligned with company growth and program needs.
  • Champion a proactive safety culture and manage safety programs, including biosafety, chemical safety, incident reporting, and emergency response.
  • Ensure compliance with relevant occupational, environmental, and biosafety regulations.
  • Manage vendor relationships for services, utilities, and facilities contractors.

Desired Qualifications

  • Experience in cell and gene therapies, device and combination products.

About the Company

Aspect Biosystems

Bioprints allogeneic tissue therapeutics

Aspect Biosystems develops bioprinted tissue therapeutics for regenerative medicine. Its work centers on a platform that combines proprietary bioprinting technology, therapeutic cells, biomaterials, and computational design to create allogeneic tissue therapeutics for clinical use. The company works through strategic collaborations with leading pharmaceutical and biotechnology firms, funded by partnerships and investors. The product approach uses bioprinting to assemble tissue constructs layer by layer from cells and biomaterials, guided by computational design, producing off-the-shelf (allogeneic) tissue therapies. What sets the company apart is its integrated platform, a focus on allogeneic, scalable tissue products, and a collaboration-driven business model with strong industry partnerships, backed by a solid funding base. Its goal is to advance regenerative medicine by delivering a targeted pipeline of bioprinted tissue therapeutics through collaborations and continued investment.

Company size
51-200
Company stage
Grant
Total funding
$352.7M
Headquarters
Vancouver, Canada
Founded
2013

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