Manufacturing Systems and Master Data Administrator
About the job
- A bachelor's degree in Engineering, Supply Chain, Information Systems, Business, Life Sciences, Computer Science, or a related discipline.
- At least 3 years of experience in manufacturing systems, supply chain systems, enterprise resource planning or manufacturing execution system administration, manufacturing operations, or master data management.
- Experience in pharmaceutical, biotechnology, cell therapy, gene therapy, or another good manufacturing practice-regulated manufacturing environment.
- Experience serving as a business owner or super user for enterprise resource planning and/or manufacturing execution system applications.
- Experience implementing or enhancing enterprise resource planning/manufacturing execution system solutions in a manufacturing environment.
- Excellent interpersonal, leadership, and communication skills.
- Serve as the business owner and super user for enterprise resource planning, manufacturing execution system, and related manufacturing systems, ensuring alignment with operational requirements and good manufacturing practice compliance.
- Develop and maintain manufacturing system standards, procedures, and work instructions.
- Partner with Information Technology and software vendors to resolve system issues and implement improvements.
- Lead User Acceptance Testing, 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 enterprise resource planning/manufacturing execution system applications.
- 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.
- 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 good manufacturing practice compliance.
- Coordinate master data changes and system changes across Procurement, Manufacturing, Quality, Manufacturing Science and Technology, and Supply Chain.
- Experience with autologous or allogeneic cell therapy supply chains.
- Certification in Production and Inventory Management or Logistics, such as APICS.
About the company
Orca Bio develops and commercializes cell therapies to improve outcomes for patients. It works by researching, developing, and producing therapies that use the body’s own cells to treat diseases, with products sold to healthcare providers who administer them to patients. The company aims to enhance the safety and effectiveness of cell therapies, making treatments more reliable for conditions that lack good options. Orca Bio differentiates itself through its focus on delivering safer, more effective therapies and by fostering a strong team culture with active stakeholder communication, including a regularly updated newsroom. Overall, its goal is to expand access to improved cell therapies and become a leading player in the cell therapy market.
Company Size
201-500
Company Stage
Debt Financing
Total Funding
$542M
Headquarters
North Fair Oaks, California
Founded
2016
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Simplify's Take
What believers are saying
- FDA approval on June 30, 2026 validates Orca Bio's platform and pipeline.
- The company raised $250 million in December 2025, funding launch and expansion.
- Princeton capacity and Sacramento hiring support commercialization and faster nationwide patient delivery.
What critics are saying
- TREGZI costs $428,000, forcing transplant centers and payers into tough coverage fights.
- Complex donor-specific manufacturing can bottleneck supply, delaying launches beyond the planned 25 centers.
- Any post-marketing safety signal or FDA CMC issue would cripple Orca Bio's only commercial product.
What makes Orca Bio unique
- Orca Bio's TREGZI won FDA approval on June 30, 2026, first precision cell therapy.
- Its donor-derived regulatory T-cell design directly reduces chronic GVHD after transplant.
- Princeton and Sacramento manufacturing create a bicoastal vein-to-vein network for personalized production.
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Benefits
Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Unlimited Paid Time Off
401(k) Retirement Plan
Parental Leave
Growth & Insights and Company News
6 month growth
0%1 year growth
3%2 year growth
0%The US Food and Drug Administration has approved Tregzi, the first regulatory T cell-based immunotherapy for improving chronic graft-versus-host disease-free survival in adult blood cancer patients undergoing stem cell transplantation. The treatment uses donor-derived immune cells to help fight cancer whilst reducing the risk of chronic GVHD, a serious complication where transplanted donor cells attack the patient's body. In the PRECISION-T trial involving 187 patients, 78% of those receiving Tregzi achieved chronic GVHD-free survival at one year, compared to 38.4% receiving standard transplants. Only 12.6% of Tregzi patients developed serious chronic GVHD within one year versus 44% in the control group. The treatment, developed by Orca Biosystems, received Orphan Drug and Regenerative Medicine Advanced Therapy designations.
Orca Bio has secured FDA approval for Tregzi, a first-of-its-kind engineered cell therapy for blood cancer patients requiring transplants. The allogeneic regulatory T cell-based immunotherapy is approved as an alternative stem cell transplant to improve survival free of chronic graft-versus-host disease in adults with hematological malignancies. In the phase 3 Precision-T trial involving 187 patients, 78% who received Tregzi were alive and free from chronic GVHD at one year, compared to 38% with standard transplants—a 74% improvement. Overall survival was 94% versus 83%. Orca is pricing Tregzi at $428,000 wholesale acquisition cost. The company recently raised $250 million and is launching at select centres, aiming for 25 by year-end. CEO Nate Fernhoff said the company is "well capitalised" for launch but didn't rule out a future IPO.
Orca Bio has received US FDA approval for TREGZI, the first precision-engineered cell therapy for matched-donor hematopoietic stem cell transplantation in adults with hematological malignancies. The therapy uses donor cells to reconstitute the immune system whilst suppressing graft-versus-host disease (GVHD). The approval is based on the Phase 3 Precision-T study of 187 patients with acute myeloid leukaemia, acute lymphoblastic leukaemia, myelodysplastic syndrome and mixed-phenotype acute leukaemia. Results showed 78% chronic GVHD-free survival at 12 months with TREGZI compared to 38% with conventional transplant. Overall survival was 94% versus 83%, whilst non-relapse mortality was 3% compared to 13%. TREGZI is a personalised treatment manufactured for each patient using living cells from a matched donor.
Orca Bio expands Sacramento workforce, adds East Coast manufacturing site ahead of approval. June 15, 2026 san francisco biotechnology network news news, syndication comments off on orca Bio expands Sacramento workforce, adds East Coast manufacturing site ahead of approval. Orca Bio, a biotechnology company that works in precision cell therapy, has expanded its Sacramento workforce and added an East Coast manufacturing center in Princeton, New Jersey, as it prepares for commercialization. Click here to view original post
Orca Bio has expanded its manufacturing capabilities ahead of the potential launch of its lead cell therapy, Orca-T, adding East Coast manufacturing capacity in Princeton, New Jersey, and tripling its West Coast manufacturing workforce in Sacramento, California. The Princeton facility will serve as a strategic East Coast manufacturing bridge, initially producing therapies for ongoing clinical programmes and supporting commercial production following potential FDA approval. The bicoastal network aims to reduce "vein-to-vein" time for patients nationwide. Orca Bio has more than tripled its Sacramento operations team over the past year, enhancing expertise in manufacturing, supply chain logistics and quality assurance. Orca-T's Biologics License Application is under FDA review, with a target action date of 6 July 2026.