Manager, Operations and Logistics Support

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� Description

• • Lead the orchestration of end-to-end manufacturing and logistics workflows at Orca Bio’s 3400 Business Drive clinical facility, ensuring that every patient batch moves seamlessly from donor blood intake through final cryopreserved drug-product release. You will act as the central hub that synchronizes Manufacturing, Quality, Facilities, Materials Management, MSAT, and IT so that life-saving cell therapies reach patients on time and in full compliance with GMP.
• • Design, document, and continuously refine Standard Operating Procedures (SOPs) and batch records that integrate QC testing milestones with production schedules. Your process maps will eliminate bottlenecks, reduce cycle times, and create transparent hand-offs between teams, directly impacting patient survival outcomes.
• • Own the master production and logistics calendar. You will schedule patient-specific donor collections, graft conditioning windows, analytical sample drop-offs, and final product shipments, while simultaneously slotting routine non-patient runs, equipment maintenance, and capital projects. Expect to juggle 50+ concurrent activities and pivot quickly when donor or patient circumstances change.
• • Serve as the primary point of contact for external logistics partners—couriers, Credo conditioning centers, and clinical sites—ensuring that temperature-controlled chain-of-custody documentation, customs paperwork, and chain-of-identity labels are flawless. You will personally review every temperature excursion report and drive CAPA when deviations occur.
• • Drive capacity-planning exercises that translate forecasted clinical demand into labor, equipment, and cold-storage requirements. You will model “what-if” scenarios for scale-up, present risk-mitigation options to senior leadership, and then execute the approved ramp-up plan, including hiring schedules, training curricula, and facility modifications.
• • Champion data integrity and digital transformation. You will upload batch data files, temperature reports, and Bills of Materials into the QA repository within 24 hours of run completion, maintain real-time dashboards on production KPIs, and configure ERP/LIMS fields to capture new process parameters as products evolve.
• • Contribute to cross-functional innovation initiatives—such as next-generation purification platforms or closed-system cryopreservation workflows—by translating R&D concepts into GMP-ready procedures. Your early involvement ensures manufacturability, regulatory alignment, and on-time tech-transfer to the clinic.
• • Mentor junior associates on gowning, aseptic technique, cold-chain handling, and documentation best practices. Your leadership will cultivate a culture where compliance is second nature and every team member understands how their role affects patient safety.
• • Manage post-run close-out with military precision: reconcile raw-material consumption, verify label accuracy, archive critical batch records, and release suites for the next campaign. You will also schedule and lead “lessons learned” sessions that feed continuous improvement cycles.
• • Maintain physical presence across both Sacramento sites (3400 Business Drive and 7910 Metro Air Parkway) as operational needs dictate. Flexibility to work weekends, holidays, or extended shifts is essential when patient timelines compress or when critical equipment validations are required.