Director, MSAT

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� Description

• • Lead the Manufacturing Science & Technology (MSAT) organization at Orca Bio’s 100,000-square-foot, state-of-the-art GMP facility in Sacramento, CA. You will own the end-to-end technical strategy that turns our next-generation, high-precision cell therapies from promising clinical candidates into reliable, scalable commercial products that can save the lives of more than one million Americans battling blood cancer.
• • Build, mentor and inspire a multidisciplinary team of scientists, engineers and technical experts who will become the go-to problem-solvers for late-stage and commercial manufacturing. Your leadership will shape hiring plans, succession pipelines and capability roadmaps so the team is always one step ahead of regulatory expectations and market demand.
• • Serve as the primary technical interface between Process Development, Quality, Operations, Regulatory Affairs and CMC. You will translate complex science into executable manufacturing strategies, ensuring seamless tech transfer, robust scale-up and flawless launch of every new process.
• • Establish and continuously refine KPIs that track process performance, product quality, right-first-time rates, cycle times and cost of goods. Use these metrics to prioritize data-driven improvements that reduce risk, increase yield and accelerate patient access.
• • Drive the design, execution and reporting of critical studies—process performance qualifications, continuous process verification, deviation investigations, comparability protocols and regulatory supportive studies—so every data package withstands FDA, EMA and PMDA scrutiny.
• • Champion a culture of rigorous scientific investigation and root-cause analysis. When deviations occur, you will lead cross-functional teams to uncover true root causes, implement sustainable corrective actions and prevent recurrence, all while maintaining 100 % GMP compliance.
• • Optimize manufacturing processes through alternate raw materials, advanced automation, novel labeling solutions and innovative shipping strategies. Your improvements will directly lower COGS, shorten vein-to-vein time and expand global access to Orca’s life-saving therapies.
• • Oversee the creation and maintenance of technical documentation—master batch records, control strategies, risk assessments, validation master plans and regulatory submission sections—ensuring traceability, clarity and alignment with global standards.
• • Collaborate with external partners, CDMOs and suppliers to qualify new technologies, secure supply continuity and maintain the highest quality standards across the value chain.
• • Present technical strategies, study outcomes and risk assessments to executive leadership, health authorities and key opinion leaders. Your communication skills will turn complex data into compelling narratives that build confidence in Orca’s science and manufacturing excellence.
• • Foster a psychologically safe, inclusive environment where curiosity, courage and integrity flourish. Model Orca’s start-up ethos by rolling up your sleeves on the cleanroom floor when needed and celebrating every milestone with the team.
• • Ensure strict adherence to cleanroom protocols—no cosmetics, jewelry or piercings—and uphold the highest standards of safety, quality and compliance in every action you and your team take.