Head of Biopharma Manufacturing & GMP Operations

Aspect Biosystems Ltd.; Fremont (CA); On-site; USD 205,000 - 240,000; Full time

Benefits offered by this job

Equity

Comprehensive benefits package

Professional development support

Job summary

Aspect Biosystems seeks a strategic, hands-on Head of Manufacturing to scale GMP-compliant operations for its bioprinted tissue programs in Fremont, CA. You will oversee aseptic manufacturing, facilities, safety, and vendor management to support clinical and commercial readiness.

Reporting to the CTO, you will build and mentor a high-performing team, drive continuous improvement, and manage capex/opex planning to enable scalable production and quality across labs and production areas.

Qualifications

• Master’s degree in Engineering, Biotechnology, Life Sciences, or related field; 10+ years in biotech/pharma operations; 5+ years in senior leadership overseeing GMP manufacturing and aseptic processing.
• Deep expertise in aseptic manufacturing, cleanroom controls, environmental monitoring, and IQ/OQ/PQ within a strict cGMP environment.
• Facility design/ops understanding, critical utility mgmt, and EHS regulatory standards for biomanufacturing environments.
• Strategic leader with hands-on approach, mentoring high-performing ops teams.

Responsibilities

• Develop and execute the manufacturing ops strategy aligned with program goals and timelines.
• Oversee aseptic manufacturing operations, cleanroom controls, environmental monitoring, and material/personnel flow to ensure GMP compliance.
• Partner cross-functionally to enable robust execution from discovery through clinical readiness.
• Build, lead, and mentor a manufacturing operations team with a culture of safety and quality.
• Manage lab operations including equipment lifecycle, calibration, and inventory management systems.
• Support implementation of manufacturing best practices, docs systems, materials mgmt, and training protocols.
• Lead day-to-day site ops and long-term facilities planning for labs, offices, and production areas.
• Oversee installation and qualification of critical manufacturing equipment (IQ/OQ/PQ) and asset lifecycle management.
• Develop robust preventative maintenance programs for facilities/equipment and ensure GMP compliance.
• Collaborate with leadership on long-range OPEX planning and facility expansion aligned with growth.
• Champion proactive safety culture including biosafety, chemical safety, incident reporting, and emergency response.
• Ensure compliance with occupational, environmental, and biosafety regs.
• Manage vendor relationships for services, utilities, and facilities contractors.

Skills

Leadership

GMP compliance

Strategic planning

Cross-functional collaboration

Budget management

Safety culture

Team mentoring

Continuous improvement

Education

Master’s degree in Engineering, Biotechnology, Life Sciences, or related field

Tools

IQ/OQ/PQ

Environmental monitoring

Job description

Aspect Biosystems seeks a strategic, hands-on Head of Manufacturing to scale GMP-compliant operations for its bioprinted tissue programs in Fremont, CA. You will oversee aseptic manufacturing, facilities, safety, and vendor management to support clinical and commercial readiness.

Reporting to the CTO, you will build and mentor a high-performing team, drive continuous improvement, and manage capex/opex planning to enable scalable production and quality across labs and production areas.