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Salary: USD 205,000 - 240,000 / annual
Aspect Biosystems, a biotechnology company developing bioprinted tissue therapeutics using AI-powered bioprinting, proprietary cell engineering, and advanced biomaterials, is seeking a Head of Manufacturing to lead its transition from research to clinical and commercial readiness.
Reporting to the Chief Technical Operations Officer, you will oversee all facility operations, lab management, safety programs, and GMP-compliant aseptic manufacturing. This is a mission-critical role responsible for scaling physical operations to support bioprinted tissue therapeutic (BTT) programs and the pipeline.
Key responsibilities include:
- Developing and executing manufacturing operations strategy aligned with organizational goals and program timelines
- Overseeing aseptic manufacturing operations, including cleanroom controls, gowning procedures, environmental monitoring, and contamination control to maintain GMP compliance
- Building, leading, and mentoring a high-performing manufacturing operations team with a focus on continuous improvement and operational excellence
- Managing lab operations including equipment lifecycle, maintenance programs, calibration, and inventory systems
- Leading site operations and long-term facilities planning to ensure labs, offices, and production areas are optimized, safe, and compliant
- Overseeing installation, qualification (IQ/OQ/PQ), maintenance, and calibration of critical manufacturing equipment
- Developing and maintaining robust preventative maintenance programs for facilities and equipment
- Collaborating with senior leadership on operational expense planning, annual budgets, and facility expansion plans
- Championing a proactive safety culture and managing comprehensive safety programs including biosafety, chemical safety, and emergency response
- Ensuring compliance with occupational, environmental, and biosafety regulations
- Managing vendor relationships for services, utilities, and facilities contractors
Requirements:
- Master's degree in Engineering, Biotechnology, Life Sciences, or related discipline
- 10+ years of experience in biotech or pharmaceutical operations (cell and gene therapies, device and combination products preferred)
- 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) in cGMP-regulated environments
- Comprehensive understanding of facility design and operations, critical utility management, and EHS regulatory standards for biomanufacturing
- Strategic leader with hands-on approach who excels at building and mentoring high-performing teams
- Driven by operational excellence, continuous improvement, and maintaining high standards for safety, quality, and accountability
- Collaborative partner capable of aligning cross-functional teams and managing vendor relationships for complex project execution
