Manager, Manufacturing Systems and Master Data

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 commercial-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 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.

Position Summary:

The Manager, Manufacturing Systems & Master Data serves as the business owner and super user for the company's Manufacturing Execution System (MES) and related manufacturing and supply chain applications. This role is responsible for governing manufacturing master data, driving system improvements, optimizing business processes, and ensuring system capabilities effectively support GMP manufacturing, inventory management, procurement, quality, planning, and commercial operations.

The Manager owns the creation and maintenance of manufacturing and supply chain master data, including material masters, inventory masters, Bills of Materials (BOMs), product specifications, packaging configurations, vendor master records, release testing requirements, and manufacturing data.

In addition, this role leads continuous improvement initiatives for ERP/MES functionality, serves as the primary business liaison to Information Technology, Finance and Software vendors, and ensures business systems evolve to meet operational and regulatory needs. No direct reports.

Serve as the business owner / user for ERP, MES, and related manufacturing systems ensuring systems align with operational requirements and GMP compliance.

• Develop and maintain manufacturing system standards, procedures, and work instructions.
• Partner with IT and software vendors to resolve system issues and implement improvements.
• Lead User Acceptance Testing (UAT), business validation activities, and deployment of system upgrades.
• Develop business requirements and functional specifications for new capabilities and enhancements.
• Own all material master records within Material Management (ERP/MES) systems.
  • Create and maintain raw materials, consumables, packaging, labels, and finished goods.
  • Create and maintain inventory attributes, storage conditions, shelf life, and lot control parameters.
  • Create and maintain Bills of Materials (BOMs).
  • Maintain manufacturing recipes and packaging configurations (where applicable).
  • Maintain material specifications and approved supplier information.
  • Link release testing requirements and quality specifications to materials.
  • Create and maintain vendor master records in partnership with Procurement.
  • Manage units of measure, conversion factors, and planning parameters.
  • Support engineering changes, change controls, and product introductions.
  • Ensure data integrity and GMP compliance.
  • Coordinate master data changes and system changes across Procurement, Manufacturing, Quality, MSAT, and Supply Chain.

Bachelor's degree in Engineering, Supply Chain, Information Systems, Business, Life Sciences, Computer Science, or a related discipline.

5+ years of experience in manufacturing systems, supply chain systems, ERP/MES administration, manufacturing operations, or master data management.

Experience in pharmaceutical, biotechnology, cell therapy, gene therapy, or other GMP-regulated manufacturing environments.

Experience serving as a business owner or super user for ERP and/or MES systems.

Experience implementing or enhancing ERP/MES solutions in a manufacturing environment

Excellent interpersonal, leadership, and communication skills.

Experience with autologous or allogeneic cell therapy supply chains, preferred.

Certification in Production and Inventory Management or Logistics, such as APICS are a plus