Posted 3 months ago

Director, Commercial Manufacturing

SacramentoOn-siteFull-time

AI Summary

The Director, Commercial Manufacturing leads cell therapy manufacturing operations and production support at Orca Bio to ensure reliable, compliant, and timely delivery of patient-specific therapies.

About this role

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.

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

Skills

Autologous ManufacturingCell TherapyCGMPContinuous ImprovementGene TherapyGMP ComplianceLean ManufacturingManufacturing OperationsProduction-supportVisual Management

Director, Commercial Manufacturing

About this role

Physical Demands

Work Conditions

Essential Duties & Key Responsibilities:

Minimum Qualifications:

Preferred Qualifications:

Skills

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