Head of Manufacturing

Aspect Biosystems•Fremont, CA

1d•$205,000 - $240,000

About The Position

We are seeking a strategic and hands-on Head of Manufacturing to join our Technical Operations team. Reporting to the Chief Technical Operations Officer you will oversee our facilities, lab operations, safety, and manufacturing operations, including aseptic manufacturing to support GMP-compliant production. This is a mission-critical role that will ensure our physical operations scale effectively to support the development and production of our bioprinted tissue therapeutic (BTT) programs as well as subsequent pipeline programs. As we continue our transition from research to clinical and commercial readiness, you will play a key role in optimizing infrastructure, enabling operational excellence, managing costs while fostering a culture of safety, quality, and accountability across our labs and manufacturing environments, with an initial focus on enabling clinical-grade production of our bioprinted tissue therapeutics.

Requirements

Master’s degree in Engineering, Biotechnology, Life Sciences, or a related discipline, with 10+ years of experience in biotech or pharmaceutical operations, cell and gene therapies, device and combination products preferred, including 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.
Strategic leader with a hands-on approach who excels at building and mentoring high-performing operational teams.
Driven by operational excellence and continuous improvement, maintaining high standards for safety, quality, and accountability.
Collaborative partner capable of aligning cross-functional teams and managing vendor relationships to execute complex project timelines.

Responsibilities

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