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Orca Bio

Posted 6 months ago

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Associate Director, Production Planning & Procurement

SacramentoOn-siteFull-time

AI Summary

Lead site production planning, scheduling and material planning for biomanufacturing, overseeing MES/ERP deployments and data-driven optimization to ensure continuous clinical and commercial cell-therapy production.

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 Associate Director, Production Planning & Procurement leads planning and procurement functions while driving the design, implementation and optimization of manufacturing execution systems (MES) and enterprise resource planning connections across cell therapy manufacturing sites. This role ensures robust, compliant and scalable planning and procurement processes with digital systems to enable accurate, real-time visibility and uninterrupted production of clinical and commercial cell therapy products. The Associate Director will partner with Manufacturing, Finance IT, Facilities and Quality to deliver a reliable planning foundation that supports operations and data-drive decision-making.

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.

    • Key Responsibilities

    • Production Planning
  • Lead site production planning, production scheduling, and material planning to meet customer service and operational targets
  • Manage production and material capacity planning aligned with clinical and commercial demand forecasts developing and analyzing operational scenarios to support capacity and demand needs.
  • Ensure effective inventory strategies to maintain optimal raw material, consumable, and finished product levels.
  • Develop Sales & Operations Planning (S&OP) processes for cell therapy programs across internal manufacturing sites.
  • Facilitate relationships with internal commercial stakeholders and suppliers and vendors, where appropriate
    • Digital Systems
  • Serve as site business lead for MES and ERP system deployment, configuration, and optimization.
  • Partner with IT, Engineering, and other functions to define requirements, ensure seamless integration, and enable end-to-end planning functionality.
  • Translate planning processes into digital workflows, ensuring master data accuracy, transactional discipline, and real-time visibility.
  • Drive user adoption, training, and change management for MES/ERP solutions at the site.
    • Process Improvement & Analytics
  • Implement best practices in production planning, leveraging system capabilities to improve forecast accuracy, scheduling efficiency, material availability, and cost competitiveness.
  • Establish KPIs and dashboards for planning performance, leveraging ERP/MES data for decision-making.
  • Identify and resolve systemic bottlenecks in planning processes through digital solutions
  • Team Leadership & Development
  • Lead, coach and develop a team of planners and system users.
  • Build a culture of digital fluency, continuous improvement and data-driven decision-making within the planning function. Build a culture of digital fluency, continuous improvement, and data-driven decision-making within the planning function.
    • Leadership
  • Effectively lead, mentor, and coach a direct team
  • Oversees the daily workflow of the department and performance to goals and deliverables
  • Recruits, interviews, hires, and trains new staff
  • Provides constructive and timely performance feedback and evaluations

    • Minimum Qualifications

  • Bachelor’s degree in Supply Chain, Engineering, Life Sciences, or related fields.
  • 5-7 years of progressive supply chain experience in biomanufacturing, cell therapies or advanced therapies.
  • Leadership of digital transformation initiatives including MES and ERP systems.
  • Strong knowledge of production planning, material requirements planning (MRP), and capacity planning within manufacturing.
  • Proven success leading cross-functional teams and driving operational results.
  • Excellent interpersonal, leadership, and communication skills.

    • Preferred Qualifications

  • Experience with autologous or allogeneic cell therapy supply chains.
  • Familiarity with both clinical and commercial supply chain models.
  • Knowledge of manufacturing, chain of identity/custody requirements, and vein-to-vein workflows.

    • Personal Qualities & Physical Demands

  • Demonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment
  • Strong interpersonal skills and ability to communicate effectively
  • Ability to work in a collaborative manner
  • Strong problem-solving skills
  • Domestic and international travel may be required from time to time as needed (approximately 10-25%). Office and GMP warehouse/manufacturing environment.
  • May require occasional lifting up to 25 lbs. and gowning into cleanroom areas.
  • Requires sitting, standing, working in an office environment and computer use.

    • Skills

    Business Process MappingCapacity PlanningChange ManagementData DashboardsDemand ForecastingDigital TransformationERPInventory ManagementIT Requirements GatheringKPIsMaster Data ManagementMaterial PlanningMESMRPProduction PlanningRoot-cause AnalysisS&OPSystems IntegrationUser TrainingWorkflow Automation

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