Position Summary:
The Manufacturing Systems & Master Data Administrator 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 Administrator 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.
Essential Duties and Responsibilities
- 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.
Required Qualifications:
- Bachelor's degree in Engineering, Supply Chain, Information Systems, Business, Life Sciences, Computer Science, or a related discipline.
- 3+ 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
Skills Required
- Bachelor's degree in Engineering, Supply Chain, Information Systems, Business, Life Sciences, Computer Science, or related discipline.
- 5+ years 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, including leading UAT and deployments.
- Proven ability to create and maintain material masters, BOMs, inventory attributes, vendor master records, manufacturing recipes, and link quality/release requirements.
- Excellent interpersonal, leadership, and communication skills.
- Experience with autologous or allogeneic cell therapy supply chains.
- Certification in Production and Inventory Management or Logistics (e.g., APICS).
What We Do
Orca Bio is a clinical-stage biotechnology company developing a pipeline of high precision allogeneic cell therapy products that are designed to safely replace patients’ diseased blood and immune system with a healthy one. Our manufacturing platform sorts donor blood with single-cell precision and a high level of purity and speed, enabling us to create proprietary, optimal therapeutic mixtures of immune and stem cells that have the potential to transform allogeneic cell therapy. Our talented team is driven by a passion for science and compassion for patients.
