Jobs at Orca Biotech

Manage cross-functional life sciences projects from initiation through implementation, focusing on CMC, technical operations, manufacturing, quality, supply chain, and clinical initiatives. Own project plans, schedules, risks, dependencies, deliverables, meetings, dashboards, RAID logs, and executive communications. Coordinate regulated implementation activities involving GMP, validation, change controls, and operational readiness while supporting PMO governance and portfolio management.

Supports quality assurance systems in a regulated cell therapy manufacturing environment. Responsibilities include managing deviations, change controls, CAPAs, and document control; reviewing batch records and release data; supporting investigations, audits, cGMP compliance, staff training, and continuous improvement initiatives. Collaborates with manufacturing, quality control, and R&D teams while maintaining data integrity and accurate quality documentation.

Support execution and documentation of process improvements, change controls, CAPA, and SOP development in a GMP-regulated cell therapy manufacturing facility. Coordinate data collection, assist root cause investigations, track project milestones, and facilitate cross-functional meetings and training to ensure compliant implementation of production changes.

Support the CEO and President by coordinating executive priorities, preparing board and executive materials, driving cross-functional strategic initiatives, improving operating rhythms, and tracking progress on company priorities. Act as a central coordinator for communication, decision-support, and follow-through across leadership teams to scale organizational effectiveness during the companys transition to commercial-stage.

Implement and maintain Orca Bio’s global quality management system across sites. Lead internal audits, supplier qualification and oversight, quality management reviews, inspection readiness, KPI trending, and QMS improvement initiatives. Partner with IT and business owners on electronic QMS enhancements, requirements, prioritization, validation, and compliance. Provide quality oversight for validation documentation and ensure consistent application of GxP and regulatory requirements across global operations.

Own gross-to-net accruals, revenue forecasting, and commercial operating expense planning for a newly commercialized pharmaceutical product. Build accrual methodologies, forecasting models, reserve reconciliations, government pricing calculations, variance analyses, and audit-ready documentation. Partner with Accounting, Market Access, Commercial, auditors, and executive leadership while supporting revenue close, ASC 606 compliance, planning-system implementation, and process automation.

Lead Orca Bios strategic partnership and licensing efforts: source, evaluate, negotiate, execute, and manage collaborations with academia, biotech, and pharma to expand the cell therapy pipeline. Provide scientific and commercial due diligence, build deal structures, advise the C-suite, and align partnerships with regulatory, manufacturing, and commercial strategies to drive value creation.

Support launch operations and analytics for a cell therapy product, embedding with cross-functional teams to build AI-enabled tools, maintain enterprise data systems (Salesforce, ERP, BI), forecast demand, support supply chain/logistics and manufacturing capacity planning, and assist market research and site onboarding.

Coordinate vein-to-vein logistics: schedule and adjust runs, assign porters and third-party couriers, prepare batch paperwork, track calendars and shipments, reconcile expenses, and serve as cross-trained backup managing live runs, incident response, and contingency decisions.

Own and govern ERP/MES manufacturing master data (materials, BOMs, inventory, vendor records), drive system improvements and UAT, develop functional requirements, ensure GMP compliance, and partner with IT, Procurement, Quality, and vendors to support manufacturing, supply chain, and commercial operations.

The Orca-T Account Manager will liaise between Orca Bio and Authorized Treatment Centers, manage relationships, ensure operational readiness, and drive therapy utilization while supporting clinical engagement.

Lead and supervise logistics and cold chain teams to ensure secure, compliant, on-time donor cell and drug product movement. Own V2V KPIs, real-time disruption response, cold chain readiness, GMP packing, chain-of-custody, vendor/courier program oversight, capacity planning, and cross-functional coordination with Manufacturing, Quality, and Clinical teams.

Field-based account manager responsible for building and maintaining relationships with Authorized Treatment Centers, ensuring site readiness and operational logistics (COI/COC), supporting clinical and commercial engagement, driving therapy utilization, gathering market insights, and representing the company at conferences. Role requires strategic planning and tactical execution to enable delivery of cell therapy treatments.

Orca Bio invites passionate candidates to join their talent community, focusing on transformative next-generation cell therapies and innovative contributions.

Support development and tech transfer of antibody and antibody-conjugate manufacturing in a GMP environment. Perform development and engineering runs, troubleshoot processes, manage GMP clean room tasks, run assays, stability and formulation studies, maintain detailed records, and collaborate with manufacturing, quality, facilities, and supply chain teams to advance clinical pipeline.

The Senior Manager / Associate Director, Cost Accounting leads cost accounting for manufacturing, overseeing product costing, inventory valuation, and financial compliance while supporting the transition from clinical to commercial stages.