Specialist, Production Project Support

📋 Description

• • Be the catalyst who turns complex manufacturing challenges into streamlined, life-saving solutions. As the Specialist, Production Project Support at Orca Bio, you will sit at the intersection of cutting-edge cell therapy science and world-class operational excellence, driving continuous improvement initiatives that directly impact the safety, quality, and timely delivery of our high-precision investigational therapies to patients fighting blood cancer.
• • Own the end-to-end lifecycle of business process improvements—from initial gap analysis through validated implementation—within our 100,000-square-foot, state-of-the-art GMP facility in Sacramento. You will map current-state workflows, quantify bottlenecks, and design future-state processes that reduce cycle time, minimize deviations, and lower cost of goods while never compromising product quality or regulatory compliance.
• • Serve as the central hub for change control execution, ensuring every modification to equipment, systems, or procedures is documented, risk-assessed, and approved in accordance with FDA, EMA, and global advanced therapy regulations. You will coordinate cross-functional review meetings, track approval workflows in our quality management system, and publish post-implementation effectiveness reports that demonstrate measurable gains.
• • Lead or support root-cause investigations and the resulting corrective and preventive actions (CAPA). You will compile batch records, deviation summaries, and environmental monitoring data; facilitate cross-functional brainstorming sessions; assign action owners; and maintain CAPA dashboards that give leadership real-time visibility into compliance status and continuous improvement momentum.
• • Author, revise, and maintain Standard Operating Procedures in close collaboration with subject-matter experts from Production, Quality Assurance, Engineering, and Validation. Your technical writing will translate complex scientific requirements into clear, user-friendly instructions that operators can execute flawlessly under cleanroom conditions, and you will coordinate training rollouts to ensure seamless adoption.
• • Build and maintain integrated project schedules using MS Project, Smartsheet, or similar tools, tracking milestones, resource allocation, and risk mitigation plans for multiple concurrent initiatives. You will prepare concise executive summaries and present findings during site leadership meetings, influencing investment decisions and strategic priorities.
• • Champion Lean Six Sigma methodologies—value-stream mapping, Kaizen events, 5S, and DMAIC projects—to embed a culture of continuous improvement across the Sacramento site. You will mentor junior staff on data-driven problem solving and celebrate wins that improve patient outcomes.
• • Ensure seamless collaboration between Production, Quality, Engineering, Supply Chain, and Regulatory Affairs by scheduling and facilitating cross-functional meetings, capturing action items, and driving accountability through transparent follow-up. Your diplomacy and communication skills will break down silos and accelerate project timelines.
• • Maintain meticulous documentation in compliance with GMP, GDP, and 21 CFR Part 11 requirements. You will own version control, archival, and retrieval systems, ensuring audit-readiness at all times and serving as a key contact during regulatory inspections.
• • Embrace an entrepreneurial mindset by asking “why not?” and challenging legacy practices. Whether it’s piloting a new digital workflow tool, optimizing gowning procedures to reduce contamination risk, or designing a visual management board that boosts operator engagement, you will experiment, iterate, and scale what works.