Head of Manufacturing

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

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.

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.

Qualifications & Experience

• Education & Experience: 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.
• You have deep expertise in aseptic manufacturing operations, cleanroom controls, environmental monitoring, and equipment qualification (IQ/OQ/PQ) within a strict cGMP-regulated environment.
• You have a comprehensive understanding of facility design and operations, critical utility management, and EHS regulatory standards for biomanufacturing environments.
• You are astrategic leader with a hands-on approach who excels at building and mentoring high-performing operational teams.
• You are driven by operational excellence and continuous improvement, maintaining high standards for safety, quality, and accountability.
• You are a collaborative partner capable of aligning cross-functional teams and managing vendor relationships to execute complex project timelines.

The hiring range for this role is $205,000 - $240,000, annually. Our pay scales are based on market data to ensure that compensation is competitive and fair. Offered salaries will be based on a combination of factors including, but not limited to, job-related knowledge, skills, education, and experience. For candidates who exceed role requirements, we are open to exploring above-range offers. Base salary is just one part of the overall compensation at Aspect, team members also receive equity, a comprehensive benefits package, and support for continuous learning and career progression.

Who We Are

Aspect Biosystems is a biotechnology company pioneering the development of a novel category of regenerative medicine designed to restore or supplement biological function and deliver curative therapies for some of the most elusive diseases. Aspect is developing these bioengineered cellular medicines by applying its full-stack tissue therapeutic platform, which integrates proprietary AI-powered bioprinting technology, therapeutic cells, hypoimmune cell engineering, and advanced biomaterials. Aspect is advancing its therapeutic pipeline across multiple endocrine and metabolic diseases, including diabetes and rare endocrine disorders. If you are committed to making a real impact and accelerating the development of life-changing therapies, we want to hear from you!

At Aspect Biosystems, our strength has always been in our diversity. Different people, thinking differently, unified in creating a world that is better for us all. We are committed to creating an inclusive environment for everyone on our team.

All aspects of employment — including the decision to hire, promote, discipline, or terminate — are based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, citizenship status, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, political affiliation, or any other status protected under federal, state, provincial, or local law.