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.
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.
Minimum Experience, Education, Certifications and Licenses:
- 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
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
Who we are
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
Notice to staffing firms
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
