Director, Commercial Manufacturing

The Director, Commercial Manufacturing is responsible for leadership of cell therapy manufacturing operations and production support functions to ensure reliable, compliant, and timely delivery of patient-specific therapies. This role drives consistent batch execution, operational discipline, and cross-functional alignment to meet on-time patient delivery while maintaining the highest standards of quality and safety.

The Director will build and sustain robust production systems, embed lean manufacturing principles, and lead continuous improvement initiatives to scale operations in a dynamic, GMP-regulated environment.

Physical Demands

• Production Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
• Most roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.

Work Conditions

• Many roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.

Essential Duties & Key Responsibilities:

Commercial Manufacturing Oversight
• Provide strategic and day-to-day leadership for GMP manufacturing operations
• Ensure consistent execution of manufacturing batches in alignment with production schedules and patient needs
• Drive right-first-time execution and minimize deviations, batch failures, and delays
• Ensure rapid resolution of manufacturing issues with minimal impact to patients
• Patient-Centric Delivery Execution
  • Own manufacturing performance metrics tied to patient delivery:
    • On-time batch release and shipment
    • Cycle time adherence
    • Schedule attainment
    • Partner cross-functionally with Quality, Supply Chain, and Patient Operations to ensure seamless delivery of autologous therapies
    • Quality and Compliance
      • Ensure full compliance with cGMP, regulatory requirements, and internal quality systems
      • Partner closely with Quality Assurance to:
        • Drive deviation reduction and investigation closure
        • Maintain inspection readiness
        • Support audits and regulatory inspections
        • Promote a strong quality culture and accountability at all levels
        • Safety Leadership
          • Champion a culture of safety across manufacturing operations
          • Ensure compliance with EHS requirements and proactively mitigate risks
          • Lead investigations and corrective actions for safety incidents
          • Lean Manufacturing and Continuous Improvement
            • Establish and sustain lean manufacturing systems, including:
              • Visual management
              • Standard work
              • Tiered accountability
              • Daily performance management
              • Lead continuous improvement initiatives to enhance:
                • Throughput
                • Capacity utilization
                • Cost efficiency
                • Process robustness
                • Utilize data-driven decision-making and performance dashboards
                • People Leadership and Development
                  • Build, lead, and develop high-performing teams across manufacturing and support functions
                  • Establish clear goals, performance expectations, and accountability structures
                  • Foster a culture of engagement, ownership, and continuous learning

Minimum Qualifications:

• Bachelor’s degree in Life Sciences, Engineering, or related field (required)
• 10+ years of experience in biopharmaceutical manufacturing, with a strong preference for cell or gene therapy
• 5+ years in senior leadership roles managing GMP manufacturing teams
• Proven experience in autologous or patient-specific manufacturing environments
• Demonstrated success in scaling manufacturing operations and improving execution performance
• Deep knowledge of cGMP regulations and regulatory expectations
• Strong background in lean manufacturing and operational excellence methodologies

Preferred Qualifications:

• Advanced degree (MS, MBA, or PhD) preferred