Director, Commercial Manufacturing
About The Position
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.
Requirements
- Bachelorâs 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
Nice To Haves
- Advanced degree (MS, MBA, or PhD) preferred
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
Benefits
- pre-IPO equity
- competitive medical, dental, and vision benefits
- PTO
- 401(k) plan
- life and accidental death and disability coverage
- parental leave benefits
- subsidized daily lunches and snacks at our on-site locations
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What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
101-250 employees
