Project Manager, Operations

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� Description

• • Be the orchestrator of life-saving breakthroughs. As Project Manager, Operations at Orca Bio’s 100,000-square-foot, state-of-the-art Sacramento facility, you will drive the cross-functional initiatives that turn pioneering cell-therapy science into commercial reality for the more than one million Americans battling blood cancer.
• • Own the end-to-end delivery of high-impact projects spanning manufacturing scale-up, tech transfer, facility expansions, quality-system enhancements, and continuous-improvement programs. You will translate strategic priorities into detailed, risk-mitigated project plans that keep every milestone on schedule and every dollar on budget.
• • Act as the single point of accountability and communication between Manufacturing, Quality, Supply Chain, Engineering, MS&T, Regulatory Affairs, and senior leadership. Your ability to synthesize technical depth with executive clarity will ensure alignment from the cleanroom floor to the boardroom.
• • Build and maintain living project charters, Gantt charts, risk registers, and KPI dashboards in tools such as MS Project or Smartsheet. You will proactively surface bottlenecks, re-allocate resources, and escalate decisions before minor slips become major delays.
• • Lead stage-gate reviews, change-control boards, and post-implementation effectiveness assessments to guarantee that every deliverable meets cGMP, FDA, EMA, and internal quality standards. Your documentation will withstand regulatory scrutiny and enable seamless tech transfer to future Orca Bio sites.
• • Coordinate readiness activities including operator training, SOP revision, equipment validation, and environmental qualification so that each project moves smoothly from “approved” to “operational” without disrupting ongoing commercial production.
• • Champion Lean Six Sigma and operational-excellence methodologies to reduce cycle times, eliminate waste, and increase capacity. You will quantify savings and present business cases that secure funding for the next wave of innovation.
• • Present concise, data-driven updates to stakeholders ranging from shift supervisors to the C-suite. Your storytelling will transform complex CMC data into compelling narratives that accelerate decision-making and maintain momentum.
• • Serve as a culture carrier for Orca Bio’s core values—passion, courage, and integrity. Whether mentoring junior associates or negotiating with external vendors, you will model urgency, scientific rigor, and compassionate focus on the patient.
• • Travel up to 10 % domestically and internationally to support due-diligence audits, vendor qualifications, and cross-site harmonization. When critical project phases demand it, you will be on-site during weekends or holidays, fully gowned and ready to troubleshoot in ISO-classified cleanroom environments.
• • Contribute to a start-up atmosphere where titles matter less than results. You will roll up your sleeves, challenge the status quo with a “why not?” mindset, and celebrate the diverse perspectives that make our solutions stronger and our impact deeper.